GMP:Blog | News, Trends and Answers to Your GMP-Questions

24.03.2025 | QUESTION OF THE WEEK

What options are there for evaluating the Quality System?

17.03.2025 | QUESTION OF THE WEEK

What does quality oversight mean?

10.03.2025 | QUESTION OF THE WEEK

How are responsibilities split between Quality Control and Quality Assurance?

03.03.2025 | QUESTION OF THE WEEK

Who is responsible for establishing the Pharmaceutical Quality System and making it work?

24.02.2025 | QUESTION OF THE WEEK

What means Limit of Quantitation (LOQ)?

17.02.2025 | QUESTION OF THE WEEK

What is a Certificate of Analysis (COA)?

10.02.2025 | QUESTION OF THE WEEK

What is a Biosafety Level (BSL)?

03.02.2025 | QUESTION OF THE WEEK

What does Annual (Product) Review mean?

27.01.2025 | QUESTION OF THE WEEK

What are endotoxins and what are their effects?

20.01.2025 | QUESTION OF THE WEEK

What requirements for "Good Distribution Practice" can be found in national and international regulations?

13.01.2025 | QUESTION OF THE WEEK

How is pure steam produced and used?

06.01.2025 | QUESTION OF THE WEEK

What are the different types of pharmaceutical water?

30.12.2024 | QUESTION OF THE WEEK

What special features need to be considered when determining the total microbial count in pharmaceutical water?

23.12.2024 | QUESTION OF THE WEEK

Where can I find specific information on the subject of "transport and temperature"?

16.12.2024 | QUESTION OF THE WEEK

What information must be included in the microbiological monitoring plan?

09.12.2024 | QUESTION OF THE WEEK

How is a physicochemical monitoring program structured?

02.12.2024 | QUESTION OF THE WEEK

Which filters are used in safety cabinets, and which filter tests are to be carried out?

25.11.2024 | QUESTION OF THE WEEK

What special factors need to be considered for sterile filtration?

18.11.2024 | QUESTION OF THE WEEK

What needs to be considered when validating a sterility test method?

11.11.2024 | QUESTION OF THE WEEK

What are isolators and what are they used for in the pharmaceutical industry?

04.11.2024 | QUESTION OF THE WEEK

What is the EDQM and what are its tasks?

28.10.2024 | QUESTION OF THE WEEK

What is the EMA and what tasks does it fulfil?

21.10.2024 | QUESTION OF THE WEEK

Which parameters are relevant in the monitoring of pharmaceutical water?

14.10.2024 | QUESTION OF THE WEEK

What types of cabinets are available?

07.10.2024 | QUESTION OF THE WEEK

What needs to be taken into account when using and maintaining safety cabinets?

30.09.2024 | QUESTION OF THE WEEK

Where can you find regulatory requirements for isolator technology?

23.09.2024 | QUESTION OF THE WEEK

What needs to be considered when validating a sterility test method?

16.09.2024 | QUESTION OF THE WEEK

What special factors need to be considered for sterile filtration?

09.09.2024 | QUESTION OF THE WEEK

What requirements are placed on cleanroom personnel?

02.09.2024 | QUESTION OF THE WEEK

What is the Sterility Assurance Level (SAL)?

26.08.2024 | QUESTION OF THE WEEK

How can a sterilisation process be checked?

19.08.2024 | QUESTION OF THE WEEK

Which sterilisation methods are used in the manufacture of sterile products?

12.08.2024 | QUESTION OF THE WEEK

What are the legal requirements for plastics?

05.08.2024 | QUESTION OF THE WEEK

What should be considered when selecting a suitable sealing material?

29.07.2024 | QUESTION OF THE WEEK

Which lubricants can be used in a GMP environment?

22.07.2024 | QUESTION OF THE WEEK

Which different types of stainless steel are available?

15.07.2024 | QUESTION OF THE WEEK

What general hygiene measures need to be observed in storage areas?

08.07.2024 | QUESTION OF THE WEEK

Which phases characterise the life cycle of a computerised system?

01.07.2024 | QUESTION OF THE WEEK

Why does it take a year to qualify the performance of a water supply system?

24.06.2024 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?

17.06.2024 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?

10.06.2024 | QUESTION OF THE WEEK

What is DIN Spec. 91323?

03.06.2024 | QUESTION OF THE WEEK

What is the advantage of Building Information Modeling (BIM) for planning new premises?

27.05.2024 | QUESTION OF THE WEEK

What is adjustment?

20.05.2024 | QUESTION OF THE WEEK

What must be observed when planning and designing distribution systems for pure steam?

13.05.2024 | QUESTION OF THE WEEK

What quality requirements must pure steam meet?

06.05.2024 | QUESTION OF THE WEEK

What are the basic physical principles of steam generation?

29.04.2024 | QUESTION OF THE WEEK

What do the authorities expect during the first inspections after the revised Annex 1 came into force?

22.04.2024 | QUESTION OF THE WEEK

What is the focus for personnel in the revised Annex 1?

15.04.2024 | QUESTION OF THE WEEK

What was the reason for the revision of Annex 1?

08.04.2024 | QUESTION OF THE WEEK

What are the major trends that have recently changed the concept of validation?

01.04.2024 | QUESTION OF THE WEEK

What must be observed when working with gloves in isolators?

25.03.2024 | QUESTION OF THE WEEK

How do you develop a process management and control strategy?

18.03.2024 | QUESTION OF THE WEEK

For what purposes are isolators used?

11.03.2024 | QUESTION OF THE WEEK

How can the specific requirements for sterile products be taken into account in the quality management system?

04.03.2024 | QUESTION OF THE WEEK

Which quality and process parameters must typically be taken into account during process validation for terminally sterilized products?

26.02.2024 | QUESTION OF THE WEEK

What do typical manufacturing processes look like?

19.02.2024 | QUESTION OF THE WEEK

What are facility control systems used for?

12.02.2024 | QUESTION OF THE WEEK

Who is responsible for the existence and effectiveness of deviation management?

05.02.2024 | QUESTION OF THE WEEK

What is cloud computing?

29.01.2024 | QUESTION OF THE WEEK

What has to be considered when releasing batches with deviations?

22.01.2024 | QUESTION OF THE WEEK

What is the purpose of process visualisation?

15.01.2024 | QUESTION OF THE WEEK

What is a deviation?

08.01.2024 | QUESTION OF THE WEEK

Which GxP critical aspects are affected when storing data in the cloud?

01.01.2024 | QUESTION OF THE WEEK

What is the difference between a corrective action and a preventive action?

25.12.2023 | QUESTION OF THE WEEK

What requirements must cleaning processes meet in terms of cleaning validation?

18.12.2023 | QUESTION OF THE WEEK

What is the difference between a correction and a corrective action?

11.12.2023 | QUESTION OF THE WEEK

What factors influence cleaning?

04.12.2023 | QUESTION OF THE WEEK

What is meant by the term 'CAPA' or 'CAPA management'?

27.11.2023 | QUESTION OF THE WEEK

How should the qualification be documented?

20.11.2023 | QUESTION OF THE WEEK

How should one handle qualification data?

13.11.2023 | QUESTION OF THE WEEK

Who is responsible for qualification?

06.11.2023 | QUESTION OF THE WEEK

What is the importance of plant design for qualification?

30.10.2023 | QUESTION OF THE WEEK

When is a determination of the conductivity useful in cleaning validation?

23.10.2023 | QUESTION OF THE WEEK

What are the advantages and disadvantages of the rinse test for cleaning validation?

16.10.2023 | QUESTION OF THE WEEK

What are the advantages and disadvantages of the swab test for cleaning validation?

09.10.2023 | QUESTION OF THE WEEK

What cleaning validation sampling procedures are available for which residues?

02.10.2023 | QUESTION OF THE WEEK

What is the official document containing official actions sent by the FDA after a GMP inspection called?

25.09.2023 | QUESTION OF THE WEEK

What are responsibilities of the Qualified Person according to EU Annex 16?

18.09.2023 | QUESTION OF THE WEEK

What are the spatial requirements for the incoming goods and dispatch areas?

11.09.2023 | QUESTION OF THE WEEK

What is an action limit?

04.09.2023 | QUESTION OF THE WEEK

When is qualification required for rooms and air handling units and when is technical acceptance testing sufficient?

28.08.2023 | QUESTION OF THE WEEK

Why is batch-specific identification necessary and how is it done?

21.08.2023 | QUESTION OF THE WEEK

What is an alert limit?

14.08.2023 | QUESTION OF THE WEEK

What general hygiene measures need to be observed?

07.08.2023 | QUESTION OF THE WEEK

What are the risks associated with microbiological monitoring?

31.07.2023 | QUESTION OF THE WEEK

Which two aspects of the storage organisation are GMP/GDP critical?

24.07.2023 | QUESTION OF THE WEEK

Which metrics are subject to monitoring?

17.07.2023 | QUESTION OF THE WEEK

What should be done with goods that have been rejected, quarantined or returned from the market?

10.07.2023 | QUESTION OF THE WEEK

Is there a difference between pharma monitoring and I&C system?

03.07.2023 | QUESTION OF THE WEEK

What is the difference between the clean up period according to Annex 1 and the recovery time according to ISO 14644-3?

26.06.2023 | QUESTION OF THE WEEK

Which processes are available for reduction of microbial counts in water systems?

19.06.2023 | QUESTION OF THE WEEK

Which persons are responsible for storage in the GMP or GDP area?

12.06.2023 | QUESTION OF THE WEEK

What are the concepts for protecting clean work areas?

05.06.2023 | QUESTION OF THE WEEK

What is rouging and how do you deal with the problem?

29.05.2023 | QUESTION OF THE WEEK

What is a Contamination Control Strategy (CCS) and what does it include?

22.05.2023 | QUESTION OF THE WEEK

What documents are required for operation of a pharmaceutical water system?

15.05.2023 | QUESTION OF THE WEEK

What is the difference between cleanroom class and air cleanliness grade?

08.05.2023 | QUESTION OF THE WEEK

What are the phases that characterise the life cycle of a computerised system?

01.05.2023 | QUESTION OF THE WEEK

What is the purpose of a responsibility matrix?

24.04.2023 | QUESTION OF THE WEEK

What is the qualification of a computerised system?

17.04.2023 | QUESTION OF THE WEEK

How can conformance with GMP requirements for active substances be proven?

10.04.2023 | QUESTION OF THE WEEK

What is the difference between strategic and tactical outsourcing?

03.04.2023 | QUESTION OF THE WEEK

What is the verification of a computerised system?

27.03.2023 | QUESTION OF THE WEEK

What are immunological medicinal products?

20.03.2023 | QUESTION OF THE WEEK

What is the validation of a computerised system?

12.03.2023 | QUESTION OF THE WEEK

What contracts are usually concluded in outsourcing?

06.03.2023 | QUESTION OF THE WEEK

What are the elements of a computerised system?

27.02.2023 | QUESTION OF THE WEEK

Which active ingredient manufacturers receive an EU GMP certificate?

20.02.2023 | QUESTION OF THE WEEK

Under what conditions may a contract acceptor subcontract activities to third parties?

13.02.2023 | QUESTION OF THE WEEK

Which product groups are included under the term immunological medicinal products?

06.02.2023 | QUESTION OF THE WEEK

In outsourcing, who is responsible for the quality of the medicinal products produced?

30.01.2023 | QUESTION OF THE WEEK

What are the objectives of personnel medical examinations?

23.01.2023 | QUESTION OF THE WEEK

What is the dual function of protective clothing in pharmaceutical manufacturing?

16.01.2023 | QUESTION OF THE WEEK

What do inspectors of premises and rooms pay particular attention to?

09.01.2023 | QUESTION OF THE WEEK

How can the suitability of premises be verified?

02.01.2023 | QUESTION OF THE WEEK

To which products does the new Annex 21 to the EU GMP Guide apply?

19.12.2022 | QUESTION OF THE WEEK

What is meant by import?

12.12.2022 | QUESTION OF THE WEEK

What are the 3 main types of safety features against drug counterfeiting?

05.12.2022 | QUESTION OF THE WEEK

What are the advantages of a dynamic e-form?

28.11.2022 | QUESTION OF THE WEEK

At what point may water be used during the performance qualification of a water supply system?

21.11.2022 | QUESTION OF THE WEEK

What is a static form?

14.11.2022 | QUESTION OF THE WEEK

Why does the performance qualification of a water supply system take one year?

07.11.2022 | QUESTION OF THE WEEK

What is a generic form?

31.10.2022 | QUESTION OF THE WEEK

What are the advantages of integrated qualification?

24.10.2022 | QUESTION OF THE WEEK

What differences are there between electronic document management systems (eDMS) and electronic quality management systems (eQMS)?

17.10.2022 | QUESTION OF THE WEEK

Which phases are distinguished in the performance qualification of a water supply system?

10.10.2022 | QUESTION OF THE WEEK

What are the main tasks of the Head of Production?

03.10.2022 | QUESTION OF THE WEEK

What are the advantages and disadvantages of in-line measurement of the conductivity of water for injection (WFI)?

26.09.2022 | QUESTION OF THE WEEK

What are endotoxins?

19.09.2022 | QUESTION OF THE WEEK

Can operators of existing systems for the production of highly purified water (HPW) still refer to the Ph. Eur. now that HPW is no longer listed there?

12.09.2022 | QUESTION OF THE WEEK

How do APR and PQR differ in terms of the number of batches to be assessed in the review period?

05.09.2022 | QUESTION OF THE WEEK

What water quality do you use for cold WFI production?

29.08.2022 | QUESTION OF THE WEEK

What is the required evaluation period for the Product Quality Review?

22.08.2022 | QUESTION OF THE WEEK

Why must sterile filters not be used in water systems to retain germs?

15.08.2022 | QUESTION OF THE WEEK

What are the responsibilities of the Qualified Person according to EU Annex 16?

08.08.2022 | QUESTION OF THE WEEK

Who is responsible for the implementation of a Batch Record Review?

01.08.2022 | QUESTION OF THE WEEK

What are the disadvantages of using activated charcoal filters in water treatment?

25.07.2022 | QUESTION OF THE WEEK

What are the main tasks of the Head of Quality Control?

18.07.2022 | QUESTION OF THE WEEK

What parameters are hidden behind "Feedwater Conductivity Equivalent", and what are they needed for?

11.07.2022 | QUESTION OF THE WEEK

What is a Batch Record Review?

04.07.2022 | QUESTION OF THE WEEK

Is it reasonable to test purified water for the presence of E. coli?

27.06.2022 | QUESTION OF THE WEEK

Where do SOPs need to be available?

20.06.2022 | QUESTION OF THE WEEK

What is a verified copy?

13.06.2022 | QUESTION OF THE WEEK

Which spray heads can be used in CIP systems?

06.06.2022 | QUESTION OF THE WEEK

What four phases should the development of a cleaning process ideally go through?

30.05.2022 | QUESTION OF THE WEEK

What types of CIP systems are used in practice?

23.05.2022 | QUESTION OF THE WEEK

What formal aspects help to improve the readability of SOPs?

16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?

09.05.2022 | QUESTION OF THE WEEK

What has to be considered in risk management?

02.05.2022 | QUESTION OF THE WEEK

To whom are SOPs addressed?

25.04.2022 | QUESTION OF THE WEEK

What is a true copy?

18.04.2022 | QUESTION OF THE WEEK

Which categories of documents do the EU GMP Guidelines identify?

11.04.2022 | QUESTION OF THE WEEK

What are the 6 different types of Excel applications?

04.04.2022 | QUESTION OF THE WEEK

What must the data owner ensure regarding data archiving?

28.03.2022 | QUESTION OF THE WEEK

From what stage in the chemical manufacturing process do GMP regulations apply?

21.03.2022 | QUESTION OF THE WEEK

What is the function of metadata for document management?

14.03.2022 | QUESTION OF THE WEEK

How do files and dossiers differ from each other?

07.03.2022 | QUESTION OF THE WEEK

What types of impurities may be present in chemical active substances?

28.02.2022 | QUESTION OF THE WEEK

What elements should be contained in a validation plan for Excel spreadsheets?

21.02.2022 | QUESTION OF THE WEEK

What is meant by archiving?

14.02.2022 | QUESTION OF THE WEEK

What is an ASMF?

07.02.2022 | QUESTION OF THE WEEK

What are the requirements for advanced electronic signatures?

31.01.2022 | QUESTION OF THE WEEK

What is an API Starting Material?

24.01.2022 | QUESTION OF THE WEEK

What is meant by registration or authorisation batches?

17.01.2022 | QUESTION OF THE WEEK

What are the 3 designs for counterfeit-proof features?

10.01.2022 | QUESTION OF THE WEEK

What is a stability commitment?

03.01.2022 | QUESTION OF THE WEEK

What is the official document containing official actions sent by the FDA after a GMP inspection called?

20.12.2021 | QUESTION OF THE WEEK

What is an end-to-end verification system?

13.12.2021 | QUESTION OF THE WEEK

What is the purpose of stability testing?

06.12.2021 | QUESTION OF THE WEEK

What are the 3 main types of safety features against counterfeit medicines?

29.11.2021 | QUESTION OF THE WEEK

What is the FDA inspection report being called?

22.11.2021 | QUESTION OF THE WEEK

What is a black-box test?

15.11.2021 | QUESTION OF THE WEEK

What is meant by front office and back office in the context of a GMP inspection?

08.11.2021 | QUESTION OF THE WEEK

What is a white-box test?

01.11.2021 | QUESTION OF THE WEEK

What is illustrated in the V model?

25.10.2021 | QUESTION OF THE WEEK

What is an Establishment Inspection Report (EIR)?

18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?

11.10.2021 | QUESTION OF THE WEEK

What are the most important QMS areas of a GMP inspection?

04.10.2021 | QUESTION OF THE WEEK

What is IT governance?

27.09.2021 | QUESTION OF THE WEEK

What is meant by offshoring?

20.09.2021 | QUESTION OF THE WEEK

When is a for-cause audit required?

13.09.2021 | QUESTION OF THE WEEK

What are the phases in the lifecycle of the supplier relationship?

06.09.2021 | QUESTION OF THE WEEK

What is a third-party audit?

30.08.2021 | QUESTION OF THE WEEK

What is the goal of supplier qualification?

23.08.2021 | QUESTION OF THE WEEK

What is the purpose of a qualification audit?

16.08.2021 | QUESTION OF THE WEEK

What is a shared audit?

09.08.2021 | QUESTION OF THE WEEK

What is pharmacovigilance?

02.08.2021 | QUESTION OF THE WEEK

What is RAN and what is its purpose?

26.07.2021 | QUESTION OF THE WEEK

What interfaces to other quality systems does the deviation management have?

19.07.2021 | QUESTION OF THE WEEK

What is the European safety referral used for?

12.07.2021 | QUESTION OF THE WEEK

How are deviations defined?

05.07.2021 | QUESTION OF THE WEEK

What is the purpose of line clearance?

28.06.2021 | QUESTION OF THE WEEK

What is the purpose of bulk filling inspection on the packaging line?

21.06.2021 | QUESTION OF THE WEEK

What significance do OEBs have?

14.06.2021 | QUESTION OF THE WEEK

What task do code readers have on a packaging line?

07.06.2021 | QUESTION OF THE WEEK

What is an OEL value?

31.05.2021 | QUESTION OF THE WEEK

What does line clearance mean?

24.05.2021 | QUESTION OF THE WEEK

For what purposes are insulators used?

17.05.2021 | QUESTION OF THE WEEK

Which GMP inspection types can be distinguished?

10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?

03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?

26.04.2021 | QUESTION OF THE WEEK

What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?

19.04.2021 | QUESTION OF THE WEEK

What is the purpose of a general GMP inspection?

12.04.2021 | QUESTION OF THE WEEK

What are the steps of an inspection procedure?

05.04.2021 | QUESTION OF THE WEEK

In which countries do the GMP rules for active ingredients according to ICH Q7 apply?

29.03.2021 | QUESTION OF THE WEEK

What activities does the distribution of active ingredients involve?

22.03.2021 | QUESTION OF THE WEEK

What should you bear in mind when maintaining rooms?

15.03.2021 | QUESTION OF THE WEEK

What is important for the processing of deviations?

08.03.2021 | QUESTION OF THE WEEK

Which metrics should be looked at when reviewing the status of a site?

01.03.2021 | QUESTION OF THE WEEK

How are self-inspections documented?

22.02.2021 | QUESTION OF THE WEEK

What does a company that has incorporated a proactive compliance program look like?

15.02.2021 | QUESTION OF THE WEEK

What are the advantages of using Ultrafiltration?

08.02.2021 | QUESTION OF THE WEEK

How do you determine the frequency of self-inspections?

01.02.2021 | QUESTION OF THE WEEK

What is the difference between an EU regulation and an EU directive?

25.01.2021 | QUESTION OF THE WEEK

What is an excipient?

18.01.2021 | QUESTION OF THE WEEK

Who developed the fishbone diagram?

11.01.2021 | QUESTION OF THE WEEK

To which areas does the self-inspection refer?

04.01.2021 | QUESTION OF THE WEEK

How does ultrafiltration work?

21.12.2020 | QUESTION OF THE WEEK

What is an active pharmaceutical ingredient (API)?

14.12.2020 | QUESTION OF THE WEEK

What is the purpose of self-inspections?

07.12.2020 | QUESTION OF THE WEEK

How does electro-deionisation work?

30.11.2020 | QUESTION OF THE WEEK

What does reworking mean in the production of APIs?

23.11.2020 | QUESTION OF THE WEEK

What is a fishbone diagram used for?

16.11.2020 | QUESTION OF THE WEEK

How do you ensure the traceability of the batch documentation?

09.11.2020 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?

02.11.2020 | QUESTION OF THE WEEK

What are the pros and cons when using UV irradiation in water pre-treatment systems?

26.10.2020 | QUESTION OF THE WEEK

What is an informal QRM method?

19.10.2020 | QUESTION OF THE WEEK

Which two factors are particularly important for a GMP-compliant process validation?

12.10.2020 | QUESTION OF THE WEEK

How does a risk assessment work?

05.10.2020 | QUESTION OF THE WEEK

How can UV irradiation be used in pharmaceutical water generation?

28.09.2020 | QUESTION OF THE WEEK

What role does quality risk management play in the quality management system?

21.09.2020 | QUESTION OF THE WEEK

In which phases is the quality risk management process divided?

14.09.2020 | QUESTION OF THE WEEK

What are the requirements for successful quality risk management (QRM)?

07.09.2020 | QUESTION OF THE WEEK

What are complexing agents and how do they work?

31.08.2020 | QUESTION OF THE WEEK

What are the advantages and benefits of quality risk management (QRM)?

24.08.2020 | QUESTION OF THE WEEK

What is a residual risk?

17.08.2020 | QUESTION OF THE WEEK

What has to be considered for risk management?

10.08.2020 | QUESTION OF THE WEEK

Why is the use of activated carbon filters critical as a pre-treatment process?

03.08.2020 | QUESTION OF THE WEEK

What is a risk?

27.07.2020 | QUESTION OF THE WEEK

What is hygienic design?

20.07.2020 | QUESTION OF THE WEEK

What is an action limit, and what happens when it is exceeded?

13.07.2020 | QUESTION OF THE WEEK

Why has drinking water to be pretreated when using it for pharmaceutical water production?

06.07.2020 | QUESTION OF THE WEEK

What is commissioning?

29.06.2020 | QUESTION OF THE WEEK

What is monitoring?

22.06.2020 | QUESTION OF THE WEEK

What is metrology?

15.06.2020 | QUESTION OF THE WEEK

What phases are involved in planning a construction project?

08.06.2020 | QUESTION OF THE WEEK

What does official calibration mean?

01.06.2020 | QUESTION OF THE WEEK

What is an alert limit, and what happens when it is exceeded?

25.05.2020 | QUESTION OF THE WEEK

What is meant by adjustment?

18.05.2020 | QUESTION OF THE WEEK

What types of requalification are distinguished?

11.05.2020 | QUESTION OF THE WEEK

What does calibration mean?

04.05.2020 | QUESTION OF THE WEEK

What is confirmed by an ATP certificate?

27.04.2020 | QUESTION OF THE WEEK

What is meant by measurement chain?

20.04.2020 | QUESTION OF THE WEEK

What data is monitored when monitoring a HVAC system?

13.04.2020 | QUESTION OF THE WEEK

Which criteria shoud be used for the selection of insulated transport boxes?

06.04.2020 | QUESTION OF THE WEEK

What is the purpose of a measurement point risk analysis?

30.03.2020 | QUESTION OF THE WEEK

What is meant by cleanroom equipment?

23.03.2020 | QUESTION OF THE WEEK

Which key aspects should be addressed when defining the requirements profile of a logistics service provider?

16.03.2020 | QUESTION OF THE WEEK

Which test is used to determine the conductivity of pharmaceutical water qualities?

09.03.2020 | QUESTION OF THE WEEK

How are medicinal products requiring cool transport conditions labeled for air freight?

02.03.2020 | QUESTION OF THE WEEK

For what purposes can drinking water be used in the pharmaceutical industry?

24.02.2020 | QUESTION OF THE WEEK

What guidelines and quality standards apply to airfreight?

17.02.2020 | QUESTION OF THE WEEK

Where is a qualification according to DIN Spec. 91323 applicable?

10.02.2020 | QUESTION OF THE WEEK

Which aspects are decisive for the performance of passive shipping containers?

03.02.2020 | QUESTION OF THE WEEK

What are the possible benefits of risk management in transportation?

27.01.2020 | QUESTION OF THE WEEK

What is meant by active and passive temperature control?

20.01.2020 | QUESTION OF THE WEEK

How can medicinal products requiring cool transport conditions be transported?

13.01.2020 | QUESTION OF THE WEEK

What are the phases of a qualification of insulated transport boxes?

06.01.2020 | QUESTION OF THE WEEK

Where can you find concrete information regarding "transport and temperature?"

30.12.2019 | QUESTION OF THE WEEK

What is DIN Spec 91323?

23.12.2019 | QUESTION OF THE WEEK

Why is temperature a critical aspect in transportation?

16.12.2019 | QUESTION OF THE WEEK

What are the central tasks of logistics?

09.12.2019 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?

02.12.2019 | QUESTION OF THE WEEK

What is the difference between a bubble type and a sink type pressure cascade?

25.11.2019 | QUESTION OF THE WEEK

What is a training profile?

18.11.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?

11.11.2019 | QUESTION OF THE WEEK

What is a root cause?

04.11.2019 | QUESTION OF THE WEEK

What is the difference between the point of occurrence and the point of recognition of a failure?

28.10.2019 | QUESTION OF THE WEEK

What is the difference between a direct cause and a contributing cause of failure?

21.10.2019 | QUESTION OF THE WEEK

What does a challenge-concept for cleaning validation mean?

14.10.2019 | QUESTION OF THE WEEK

What is industrial hygiene?

07.10.2019 | QUESTION OF THE WEEK

Who is responsible for planning and implementing cleaning validation?

30.09.2019 | QUESTION OF THE WEEK

Which countries are covered by the British Pharmacopoeia?

23.09.2019 | QUESTION OF THE WEEK

What is adjustment?

16.09.2019 | QUESTION OF THE WEEK

Do European Pharmacopoeia methods need to be validated by the user?

09.09.2019 | QUESTION OF THE WEEK

What is gauging?

02.09.2019 | QUESTION OF THE WEEK

Do USP methods need to be validated by the user?

26.08.2019 | QUESTION OF THE WEEK

What is calibration?

19.08.2019 | QUESTION OF THE WEEK

What is the link between the European and the British Pharmacopoeia?

12.08.2019 | QUESTION OF THE WEEK

What is commissioning?

05.08.2019 | QUESTION OF THE WEEK

What is the legal status of the the European Pharmacopoeia?

29.07.2019 | QUESTION OF THE WEEK

What is the objective of laboratory equipment qualification?

22.07.2019 | QUESTION OF THE WEEK

What is adjustment?

15.07.2019 | QUESTION OF THE WEEK

What is the Design Qualification?

08.07.2019 | QUESTION OF THE WEEK

Why is a system suitability test (SST) performed in addition to equipment qualification?

01.07.2019 | QUESTION OF THE WEEK

When is it imperative to monitor transport temperatures for finished drug products?

24.06.2019 | QUESTION OF THE WEEK

Which criteria are to be considered when selecting cleaning agents?

17.06.2019 | QUESTION OF THE WEEK

How should raw data be handled?

10.06.2019 | QUESTION OF THE WEEK

Why should OQ tests cover the entire working range of the equipment?

03.06.2019 | QUESTION OF THE WEEK

Who is responsible for generating the PQ protocols?

27.05.2019 | QUESTION OF THE WEEK

Which are the key aspects of personnel hygiene?

20.05.2019 | QUESTION OF THE WEEK

What is the difference between an EDMS and an EQMS?

13.05.2019 | QUESTION OF THE WEEK

What are the so-called safety features on packaging materials?

06.05.2019 | QUESTION OF THE WEEK

What is the advantage of a 2D-MatrixCode?

29.04.2019 | QUESTION OF THE WEEK

How can a uniform colouring of secondary packaging materials be achieved?

22.04.2019 | QUESTION OF THE WEEK

What is meant by serialisation?

15.04.2019 | QUESTION OF THE WEEK

What are print data for secondary packaging materials?

08.04.2019 | QUESTION OF THE WEEK

What is the disadvantage of a sit-over bench?

01.04.2019 | QUESTION OF THE WEEK

Is it acceptable to use a transport trolley for material transfer from one cleanliness class to another?

25.03.2019 | QUESTION OF THE WEEK

Which materials can be used for furniture and furnishings in cleanliness Grade C?

18.03.2019 | QUESTION OF THE WEEK

What are the major trends that have changed the concept of validation recently?

11.03.2019 | QUESTION OF THE WEEK

What should be considered when installing automatic sliding doors in cleanrooms?

04.03.2019 | QUESTION OF THE WEEK

What is the advantage of Building Information Modeling (BIM) for planning new premises?

25.02.2019 | QUESTION OF THE WEEK

Which role plays a runner during an inspection?

18.02.2019 | QUESTION OF THE WEEK

What is the difference between a bubble type and a sink type pressure cascade?

11.02.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?

04.02.2019 | QUESTION OF THE WEEK

What is meant by the term "metadata"?

28.01.2019 | QUESTION OF THE WEEK

Is it necessary to wear gloves in cleanroom class D?

21.01.2019 | QUESTION OF THE WEEK

What is the significance of growth controls in microbiological monitoring?

14.01.2019 | QUESTION OF THE WEEK

What is the minimum requirement for cleaned equipment?

07.01.2019 | QUESTION OF THE WEEK

Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?

31.12.2018 | QUESTION OF THE WEEK

What is a training profile?

24.12.2018 | QUESTION OF THE WEEK

What is the significance of an action level?

17.12.2018 | QUESTION OF THE WEEK

Should calibration be done during IQ or as part of OQ?

10.12.2018 | QUESTION OF THE WEEK

What is the significance of an alert level?

03.12.2018 | QUESTION OF THE WEEK

Welche Voraussetzungen müssen bei der Vergabe von Prüfungen an ein Lohnlabor zwingend erfüllt sein?

26.11.2018 | QUESTION OF THE WEEK

Welche Anforderung wird an ein Auftragslabor gestellt, das neben der Prüfung auch eine Freigabe durchführt?

19.11.2018 | QUESTION OF THE WEEK

Was versteht man unter Device Master Record (DMR) und Device History Record (DHR)?

05.11.2018 | QUESTION OF THE WEEK

Welche Bedeutung haben Ionenaustauscher bei der Pharmawasseraufbereitung?

29.10.2018 | QUESTION OF THE WEEK

Für welche Zwecke werden UV-Strahler in Wasseraufbereitungsanlagen eingesetzt?

22.10.2018 | QUESTION OF THE WEEK

Was ist Ultrafiltration und wofür wird sie eingesetzt?

10.09.2018 | QUESTION OF THE WEEK

Wie ist die Instandhaltungsrate definiert?

03.09.2018 | QUESTION OF THE WEEK

Welche Maßnahmen beinhaltet die Instandhaltung?

27.08.2018 | QUESTION OF THE WEEK

Welche Aufgabe erfüllt die Instandhaltung?

24.03.2025 | QUESTION OF THE WEEK

What options are there for evaluating the Quality System?

10.03.2025 | QUESTION OF THE WEEK

How are responsibilities split between Quality Control and Quality Assurance?

24.02.2025 | QUESTION OF THE WEEK

What means Limit of Quantitation (LOQ)?

10.02.2025 | QUESTION OF THE WEEK

What is a Biosafety Level (BSL)?

27.01.2025 | QUESTION OF THE WEEK

What are endotoxins and what are their effects?

13.01.2025 | QUESTION OF THE WEEK

How is pure steam produced and used?

30.12.2024 | QUESTION OF THE WEEK

What special features need to be considered when determining the total microbial count in pharmaceutical water?

16.12.2024 | QUESTION OF THE WEEK

What information must be included in the microbiological monitoring plan?

02.12.2024 | QUESTION OF THE WEEK

Which filters are used in safety cabinets, and which filter tests are to be carried out?

18.11.2024 | QUESTION OF THE WEEK

What needs to be considered when validating a sterility test method?

04.11.2024 | QUESTION OF THE WEEK

What is the EDQM and what are its tasks?

21.10.2024 | QUESTION OF THE WEEK

Which parameters are relevant in the monitoring of pharmaceutical water?

07.10.2024 | QUESTION OF THE WEEK

What needs to be taken into account when using and maintaining safety cabinets?

23.09.2024 | QUESTION OF THE WEEK

What needs to be considered when validating a sterility test method?

09.09.2024 | QUESTION OF THE WEEK

What requirements are placed on cleanroom personnel?

26.08.2024 | QUESTION OF THE WEEK

How can a sterilisation process be checked?

12.08.2024 | QUESTION OF THE WEEK

What are the legal requirements for plastics?

29.07.2024 | QUESTION OF THE WEEK

Which lubricants can be used in a GMP environment?

15.07.2024 | QUESTION OF THE WEEK

What general hygiene measures need to be observed in storage areas?

01.07.2024 | QUESTION OF THE WEEK

Why does it take a year to qualify the performance of a water supply system?

17.06.2024 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?

03.06.2024 | QUESTION OF THE WEEK

What is the advantage of Building Information Modeling (BIM) for planning new premises?

20.05.2024 | QUESTION OF THE WEEK

What must be observed when planning and designing distribution systems for pure steam?

06.05.2024 | QUESTION OF THE WEEK

What are the basic physical principles of steam generation?

22.04.2024 | QUESTION OF THE WEEK

What is the focus for personnel in the revised Annex 1?

08.04.2024 | QUESTION OF THE WEEK

What are the major trends that have recently changed the concept of validation?

25.03.2024 | QUESTION OF THE WEEK

How do you develop a process management and control strategy?

11.03.2024 | QUESTION OF THE WEEK

How can the specific requirements for sterile products be taken into account in the quality management system?

26.02.2024 | QUESTION OF THE WEEK

What do typical manufacturing processes look like?

12.02.2024 | QUESTION OF THE WEEK

Who is responsible for the existence and effectiveness of deviation management?

29.01.2024 | QUESTION OF THE WEEK

What has to be considered when releasing batches with deviations?

15.01.2024 | QUESTION OF THE WEEK

What is a deviation?

01.01.2024 | QUESTION OF THE WEEK

What is the difference between a corrective action and a preventive action?

18.12.2023 | QUESTION OF THE WEEK

What is the difference between a correction and a corrective action?

04.12.2023 | QUESTION OF THE WEEK

What is meant by the term 'CAPA' or 'CAPA management'?

20.11.2023 | QUESTION OF THE WEEK

How should one handle qualification data?

06.11.2023 | QUESTION OF THE WEEK

What is the importance of plant design for qualification?

23.10.2023 | QUESTION OF THE WEEK

What are the advantages and disadvantages of the rinse test for cleaning validation?

09.10.2023 | QUESTION OF THE WEEK

What cleaning validation sampling procedures are available for which residues?

25.09.2023 | QUESTION OF THE WEEK

What are responsibilities of the Qualified Person according to EU Annex 16?

11.09.2023 | QUESTION OF THE WEEK

What is an action limit?

28.08.2023 | QUESTION OF THE WEEK

Why is batch-specific identification necessary and how is it done?

14.08.2023 | QUESTION OF THE WEEK

What general hygiene measures need to be observed?

31.07.2023 | QUESTION OF THE WEEK

Which two aspects of the storage organisation are GMP/GDP critical?

17.07.2023 | QUESTION OF THE WEEK

What should be done with goods that have been rejected, quarantined or returned from the market?

03.07.2023 | QUESTION OF THE WEEK

What is the difference between the clean up period according to Annex 1 and the recovery time according to ISO 14644-3?

19.06.2023 | QUESTION OF THE WEEK

Which persons are responsible for storage in the GMP or GDP area?

05.06.2023 | QUESTION OF THE WEEK

What is rouging and how do you deal with the problem?

22.05.2023 | QUESTION OF THE WEEK

What documents are required for operation of a pharmaceutical water system?

08.05.2023 | QUESTION OF THE WEEK

What are the phases that characterise the life cycle of a computerised system?

24.04.2023 | QUESTION OF THE WEEK

What is the qualification of a computerised system?

10.04.2023 | QUESTION OF THE WEEK

What is the difference between strategic and tactical outsourcing?

27.03.2023 | QUESTION OF THE WEEK

What are immunological medicinal products?

12.03.2023 | QUESTION OF THE WEEK

What contracts are usually concluded in outsourcing?

27.02.2023 | QUESTION OF THE WEEK

Which active ingredient manufacturers receive an EU GMP certificate?

13.02.2023 | QUESTION OF THE WEEK

Which product groups are included under the term immunological medicinal products?

30.01.2023 | QUESTION OF THE WEEK

What are the objectives of personnel medical examinations?

16.01.2023 | QUESTION OF THE WEEK

What do inspectors of premises and rooms pay particular attention to?

02.01.2023 | QUESTION OF THE WEEK

To which products does the new Annex 21 to the EU GMP Guide apply?

12.12.2022 | QUESTION OF THE WEEK

What are the 3 main types of safety features against drug counterfeiting?

28.11.2022 | QUESTION OF THE WEEK

At what point may water be used during the performance qualification of a water supply system?

14.11.2022 | QUESTION OF THE WEEK

Why does the performance qualification of a water supply system take one year?

31.10.2022 | QUESTION OF THE WEEK

What are the advantages of integrated qualification?

17.10.2022 | QUESTION OF THE WEEK

Which phases are distinguished in the performance qualification of a water supply system?

03.10.2022 | QUESTION OF THE WEEK

What are the advantages and disadvantages of in-line measurement of the conductivity of water for injection (WFI)?

19.09.2022 | QUESTION OF THE WEEK

Can operators of existing systems for the production of highly purified water (HPW) still refer to the Ph. Eur. now that HPW is no longer listed there?

05.09.2022 | QUESTION OF THE WEEK

What water quality do you use for cold WFI production?

22.08.2022 | QUESTION OF THE WEEK

Why must sterile filters not be used in water systems to retain germs?

08.08.2022 | QUESTION OF THE WEEK

Who is responsible for the implementation of a Batch Record Review?

25.07.2022 | QUESTION OF THE WEEK

What are the main tasks of the Head of Quality Control?

11.07.2022 | QUESTION OF THE WEEK

What is a Batch Record Review?

27.06.2022 | QUESTION OF THE WEEK

Where do SOPs need to be available?

13.06.2022 | QUESTION OF THE WEEK

Which spray heads can be used in CIP systems?

30.05.2022 | QUESTION OF THE WEEK

What types of CIP systems are used in practice?

16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?

02.05.2022 | QUESTION OF THE WEEK

To whom are SOPs addressed?

18.04.2022 | QUESTION OF THE WEEK

Which categories of documents do the EU GMP Guidelines identify?

04.04.2022 | QUESTION OF THE WEEK

What must the data owner ensure regarding data archiving?

21.03.2022 | QUESTION OF THE WEEK

What is the function of metadata for document management?

07.03.2022 | QUESTION OF THE WEEK

What types of impurities may be present in chemical active substances?

21.02.2022 | QUESTION OF THE WEEK

What is meant by archiving?

07.02.2022 | QUESTION OF THE WEEK

What are the requirements for advanced electronic signatures?

24.01.2022 | QUESTION OF THE WEEK

What is meant by registration or authorisation batches?

10.01.2022 | QUESTION OF THE WEEK

What is a stability commitment?

20.12.2021 | QUESTION OF THE WEEK

What is an end-to-end verification system?

06.12.2021 | QUESTION OF THE WEEK

What are the 3 main types of safety features against counterfeit medicines?

22.11.2021 | QUESTION OF THE WEEK

What is a black-box test?

08.11.2021 | QUESTION OF THE WEEK

What is a white-box test?

25.10.2021 | QUESTION OF THE WEEK

What is an Establishment Inspection Report (EIR)?

11.10.2021 | QUESTION OF THE WEEK

What are the most important QMS areas of a GMP inspection?

27.09.2021 | QUESTION OF THE WEEK

What is meant by offshoring?

13.09.2021 | QUESTION OF THE WEEK

What are the phases in the lifecycle of the supplier relationship?

30.08.2021 | QUESTION OF THE WEEK

What is the goal of supplier qualification?

16.08.2021 | QUESTION OF THE WEEK

What is a shared audit?

02.08.2021 | QUESTION OF THE WEEK

What is RAN and what is its purpose?

19.07.2021 | QUESTION OF THE WEEK

What is the European safety referral used for?

05.07.2021 | QUESTION OF THE WEEK

What is the purpose of line clearance?

21.06.2021 | QUESTION OF THE WEEK

What significance do OEBs have?

07.06.2021 | QUESTION OF THE WEEK

What is an OEL value?

24.05.2021 | QUESTION OF THE WEEK

For what purposes are insulators used?

10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?

26.04.2021 | QUESTION OF THE WEEK

What information is required for the registration of any manufacturers, importers and distributors of active substances in the EU?

12.04.2021 | QUESTION OF THE WEEK

What are the steps of an inspection procedure?

29.03.2021 | QUESTION OF THE WEEK

What activities does the distribution of active ingredients involve?

15.03.2021 | QUESTION OF THE WEEK

What is important for the processing of deviations?

01.03.2021 | QUESTION OF THE WEEK

How are self-inspections documented?

15.02.2021 | QUESTION OF THE WEEK

What are the advantages of using Ultrafiltration?

01.02.2021 | QUESTION OF THE WEEK

What is the difference between an EU regulation and an EU directive?

18.01.2021 | QUESTION OF THE WEEK

Who developed the fishbone diagram?

04.01.2021 | QUESTION OF THE WEEK

How does ultrafiltration work?

14.12.2020 | QUESTION OF THE WEEK

What is the purpose of self-inspections?

30.11.2020 | QUESTION OF THE WEEK

What does reworking mean in the production of APIs?

16.11.2020 | QUESTION OF THE WEEK

How do you ensure the traceability of the batch documentation?

02.11.2020 | QUESTION OF THE WEEK

What are the pros and cons when using UV irradiation in water pre-treatment systems?

19.10.2020 | QUESTION OF THE WEEK

Which two factors are particularly important for a GMP-compliant process validation?

05.10.2020 | QUESTION OF THE WEEK

How can UV irradiation be used in pharmaceutical water generation?

21.09.2020 | QUESTION OF THE WEEK

In which phases is the quality risk management process divided?

07.09.2020 | QUESTION OF THE WEEK

What are complexing agents and how do they work?

24.08.2020 | QUESTION OF THE WEEK

What is a residual risk?

10.08.2020 | QUESTION OF THE WEEK

Why is the use of activated carbon filters critical as a pre-treatment process?

27.07.2020 | QUESTION OF THE WEEK

What is hygienic design?

13.07.2020 | QUESTION OF THE WEEK

Why has drinking water to be pretreated when using it for pharmaceutical water production?

29.06.2020 | QUESTION OF THE WEEK

What is monitoring?

15.06.2020 | QUESTION OF THE WEEK

What phases are involved in planning a construction project?

01.06.2020 | QUESTION OF THE WEEK

What is an alert limit, and what happens when it is exceeded?

18.05.2020 | QUESTION OF THE WEEK

What types of requalification are distinguished?

04.05.2020 | QUESTION OF THE WEEK

What is confirmed by an ATP certificate?

20.04.2020 | QUESTION OF THE WEEK

What data is monitored when monitoring a HVAC system?

06.04.2020 | QUESTION OF THE WEEK

What is the purpose of a measurement point risk analysis?

23.03.2020 | QUESTION OF THE WEEK

Which key aspects should be addressed when defining the requirements profile of a logistics service provider?

09.03.2020 | QUESTION OF THE WEEK

How are medicinal products requiring cool transport conditions labeled for air freight?

24.02.2020 | QUESTION OF THE WEEK

What guidelines and quality standards apply to airfreight?

10.02.2020 | QUESTION OF THE WEEK

Which aspects are decisive for the performance of passive shipping containers?

27.01.2020 | QUESTION OF THE WEEK

What is meant by active and passive temperature control?

13.01.2020 | QUESTION OF THE WEEK

What are the phases of a qualification of insulated transport boxes?

30.12.2019 | QUESTION OF THE WEEK

What is DIN Spec 91323?

16.12.2019 | QUESTION OF THE WEEK

What are the central tasks of logistics?

02.12.2019 | QUESTION OF THE WEEK

What is the difference between a bubble type and a sink type pressure cascade?

18.11.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?

04.11.2019 | QUESTION OF THE WEEK

What is the difference between the point of occurrence and the point of recognition of a failure?

21.10.2019 | QUESTION OF THE WEEK

What does a challenge-concept for cleaning validation mean?

07.10.2019 | QUESTION OF THE WEEK

Who is responsible for planning and implementing cleaning validation?

23.09.2019 | QUESTION OF THE WEEK

What is adjustment?

09.09.2019 | QUESTION OF THE WEEK

What is gauging?

26.08.2019 | QUESTION OF THE WEEK

What is calibration?

12.08.2019 | QUESTION OF THE WEEK

What is commissioning?

29.07.2019 | QUESTION OF THE WEEK

What is the objective of laboratory equipment qualification?

15.07.2019 | QUESTION OF THE WEEK

What is the Design Qualification?

01.07.2019 | QUESTION OF THE WEEK

When is it imperative to monitor transport temperatures for finished drug products?

17.06.2019 | QUESTION OF THE WEEK

How should raw data be handled?

03.06.2019 | QUESTION OF THE WEEK

Who is responsible for generating the PQ protocols?

20.05.2019 | QUESTION OF THE WEEK

What is the difference between an EDMS and an EQMS?

06.05.2019 | QUESTION OF THE WEEK

What is the advantage of a 2D-MatrixCode?

22.04.2019 | QUESTION OF THE WEEK

What is meant by serialisation?

08.04.2019 | QUESTION OF THE WEEK

What is the disadvantage of a sit-over bench?

25.03.2019 | QUESTION OF THE WEEK

Which materials can be used for furniture and furnishings in cleanliness Grade C?

11.03.2019 | QUESTION OF THE WEEK

What should be considered when installing automatic sliding doors in cleanrooms?

25.02.2019 | QUESTION OF THE WEEK

Which role plays a runner during an inspection?

11.02.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?

28.01.2019 | QUESTION OF THE WEEK

Is it necessary to wear gloves in cleanroom class D?

14.01.2019 | QUESTION OF THE WEEK

What is the minimum requirement for cleaned equipment?

31.12.2018 | QUESTION OF THE WEEK

What is a training profile?

17.12.2018 | QUESTION OF THE WEEK

Should calibration be done during IQ or as part of OQ?

03.12.2018 | QUESTION OF THE WEEK

Welche Voraussetzungen müssen bei der Vergabe von Prüfungen an ein Lohnlabor zwingend erfüllt sein?

19.11.2018 | QUESTION OF THE WEEK

Was versteht man unter Device Master Record (DMR) und Device History Record (DHR)?

29.10.2018 | QUESTION OF THE WEEK

Für welche Zwecke werden UV-Strahler in Wasseraufbereitungsanlagen eingesetzt?

10.09.2018 | QUESTION OF THE WEEK

Wie ist die Instandhaltungsrate definiert?

27.08.2018 | QUESTION OF THE WEEK

Welche Aufgabe erfüllt die Instandhaltung?

17.03.2025 | QUESTION OF THE WEEK

What does quality oversight mean?

03.03.2025 | QUESTION OF THE WEEK

Who is responsible for establishing the Pharmaceutical Quality System and making it work?

17.02.2025 | QUESTION OF THE WEEK

What is a Certificate of Analysis (COA)?

03.02.2025 | QUESTION OF THE WEEK

What does Annual (Product) Review mean?

20.01.2025 | QUESTION OF THE WEEK

What requirements for "Good Distribution Practice" can be found in national and international regulations?

06.01.2025 | QUESTION OF THE WEEK

What are the different types of pharmaceutical water?

23.12.2024 | QUESTION OF THE WEEK

Where can I find specific information on the subject of "transport and temperature"?

09.12.2024 | QUESTION OF THE WEEK

How is a physicochemical monitoring program structured?

25.11.2024 | QUESTION OF THE WEEK

What special factors need to be considered for sterile filtration?

11.11.2024 | QUESTION OF THE WEEK

What are isolators and what are they used for in the pharmaceutical industry?

28.10.2024 | QUESTION OF THE WEEK

What is the EMA and what tasks does it fulfil?

14.10.2024 | QUESTION OF THE WEEK

What types of cabinets are available?

30.09.2024 | QUESTION OF THE WEEK

Where can you find regulatory requirements for isolator technology?

16.09.2024 | QUESTION OF THE WEEK

What special factors need to be considered for sterile filtration?

02.09.2024 | QUESTION OF THE WEEK

What is the Sterility Assurance Level (SAL)?

19.08.2024 | QUESTION OF THE WEEK

Which sterilisation methods are used in the manufacture of sterile products?

05.08.2024 | QUESTION OF THE WEEK

What should be considered when selecting a suitable sealing material?

22.07.2024 | QUESTION OF THE WEEK

Which different types of stainless steel are available?

08.07.2024 | QUESTION OF THE WEEK

Which phases characterise the life cycle of a computerised system?

24.06.2024 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?

10.06.2024 | QUESTION OF THE WEEK

What is DIN Spec. 91323?

27.05.2024 | QUESTION OF THE WEEK

What is adjustment?

13.05.2024 | QUESTION OF THE WEEK

What quality requirements must pure steam meet?

29.04.2024 | QUESTION OF THE WEEK

What do the authorities expect during the first inspections after the revised Annex 1 came into force?

15.04.2024 | QUESTION OF THE WEEK

What was the reason for the revision of Annex 1?

01.04.2024 | QUESTION OF THE WEEK

What must be observed when working with gloves in isolators?

18.03.2024 | QUESTION OF THE WEEK

For what purposes are isolators used?

04.03.2024 | QUESTION OF THE WEEK

Which quality and process parameters must typically be taken into account during process validation for terminally sterilized products?

19.02.2024 | QUESTION OF THE WEEK

What are facility control systems used for?

05.02.2024 | QUESTION OF THE WEEK

What is cloud computing?

22.01.2024 | QUESTION OF THE WEEK

What is the purpose of process visualisation?

08.01.2024 | QUESTION OF THE WEEK

Which GxP critical aspects are affected when storing data in the cloud?

25.12.2023 | QUESTION OF THE WEEK

What requirements must cleaning processes meet in terms of cleaning validation?

11.12.2023 | QUESTION OF THE WEEK

What factors influence cleaning?

27.11.2023 | QUESTION OF THE WEEK

How should the qualification be documented?

13.11.2023 | QUESTION OF THE WEEK

Who is responsible for qualification?

30.10.2023 | QUESTION OF THE WEEK

When is a determination of the conductivity useful in cleaning validation?

16.10.2023 | QUESTION OF THE WEEK

What are the advantages and disadvantages of the swab test for cleaning validation?

02.10.2023 | QUESTION OF THE WEEK

What is the official document containing official actions sent by the FDA after a GMP inspection called?

18.09.2023 | QUESTION OF THE WEEK

What are the spatial requirements for the incoming goods and dispatch areas?

04.09.2023 | QUESTION OF THE WEEK

When is qualification required for rooms and air handling units and when is technical acceptance testing sufficient?

21.08.2023 | QUESTION OF THE WEEK

What is an alert limit?

07.08.2023 | QUESTION OF THE WEEK

What are the risks associated with microbiological monitoring?

24.07.2023 | QUESTION OF THE WEEK

Which metrics are subject to monitoring?

10.07.2023 | QUESTION OF THE WEEK

Is there a difference between pharma monitoring and I&C system?

26.06.2023 | QUESTION OF THE WEEK

Which processes are available for reduction of microbial counts in water systems?

12.06.2023 | QUESTION OF THE WEEK

What are the concepts for protecting clean work areas?

29.05.2023 | QUESTION OF THE WEEK

What is a Contamination Control Strategy (CCS) and what does it include?

15.05.2023 | QUESTION OF THE WEEK

What is the difference between cleanroom class and air cleanliness grade?

01.05.2023 | QUESTION OF THE WEEK

What is the purpose of a responsibility matrix?

17.04.2023 | QUESTION OF THE WEEK

How can conformance with GMP requirements for active substances be proven?

03.04.2023 | QUESTION OF THE WEEK

What is the verification of a computerised system?

20.03.2023 | QUESTION OF THE WEEK

What is the validation of a computerised system?

06.03.2023 | QUESTION OF THE WEEK

What are the elements of a computerised system?

20.02.2023 | QUESTION OF THE WEEK

Under what conditions may a contract acceptor subcontract activities to third parties?

06.02.2023 | QUESTION OF THE WEEK

In outsourcing, who is responsible for the quality of the medicinal products produced?

23.01.2023 | QUESTION OF THE WEEK

What is the dual function of protective clothing in pharmaceutical manufacturing?

09.01.2023 | QUESTION OF THE WEEK

How can the suitability of premises be verified?

19.12.2022 | QUESTION OF THE WEEK

What is meant by import?

05.12.2022 | QUESTION OF THE WEEK

What are the advantages of a dynamic e-form?

21.11.2022 | QUESTION OF THE WEEK

What is a static form?

07.11.2022 | QUESTION OF THE WEEK

What is a generic form?

24.10.2022 | QUESTION OF THE WEEK

What differences are there between electronic document management systems (eDMS) and electronic quality management systems (eQMS)?

10.10.2022 | QUESTION OF THE WEEK

What are the main tasks of the Head of Production?

26.09.2022 | QUESTION OF THE WEEK

What are endotoxins?

12.09.2022 | QUESTION OF THE WEEK

How do APR and PQR differ in terms of the number of batches to be assessed in the review period?

29.08.2022 | QUESTION OF THE WEEK

What is the required evaluation period for the Product Quality Review?

15.08.2022 | QUESTION OF THE WEEK

What are the responsibilities of the Qualified Person according to EU Annex 16?

01.08.2022 | QUESTION OF THE WEEK

What are the disadvantages of using activated charcoal filters in water treatment?

18.07.2022 | QUESTION OF THE WEEK

What parameters are hidden behind "Feedwater Conductivity Equivalent", and what are they needed for?

04.07.2022 | QUESTION OF THE WEEK

Is it reasonable to test purified water for the presence of E. coli?

20.06.2022 | QUESTION OF THE WEEK

What is a verified copy?

06.06.2022 | QUESTION OF THE WEEK

What four phases should the development of a cleaning process ideally go through?

23.05.2022 | QUESTION OF THE WEEK

What formal aspects help to improve the readability of SOPs?

09.05.2022 | QUESTION OF THE WEEK

What has to be considered in risk management?

25.04.2022 | QUESTION OF THE WEEK

What is a true copy?

11.04.2022 | QUESTION OF THE WEEK

What are the 6 different types of Excel applications?

28.03.2022 | QUESTION OF THE WEEK

From what stage in the chemical manufacturing process do GMP regulations apply?

14.03.2022 | QUESTION OF THE WEEK

How do files and dossiers differ from each other?

28.02.2022 | QUESTION OF THE WEEK

What elements should be contained in a validation plan for Excel spreadsheets?

14.02.2022 | QUESTION OF THE WEEK

What is an ASMF?

31.01.2022 | QUESTION OF THE WEEK

What is an API Starting Material?

17.01.2022 | QUESTION OF THE WEEK

What are the 3 designs for counterfeit-proof features?

03.01.2022 | QUESTION OF THE WEEK

What is the official document containing official actions sent by the FDA after a GMP inspection called?

13.12.2021 | QUESTION OF THE WEEK

What is the purpose of stability testing?

29.11.2021 | QUESTION OF THE WEEK

What is the FDA inspection report being called?

15.11.2021 | QUESTION OF THE WEEK

What is meant by front office and back office in the context of a GMP inspection?

01.11.2021 | QUESTION OF THE WEEK

What is illustrated in the V model?

18.10.2021 | QUESTION OF THE WEEK

What is a computerised system?

04.10.2021 | QUESTION OF THE WEEK

What is IT governance?

20.09.2021 | QUESTION OF THE WEEK

When is a for-cause audit required?

06.09.2021 | QUESTION OF THE WEEK

What is a third-party audit?

23.08.2021 | QUESTION OF THE WEEK

What is the purpose of a qualification audit?

09.08.2021 | QUESTION OF THE WEEK

What is pharmacovigilance?

26.07.2021 | QUESTION OF THE WEEK

What interfaces to other quality systems does the deviation management have?

12.07.2021 | QUESTION OF THE WEEK

How are deviations defined?

28.06.2021 | QUESTION OF THE WEEK

What is the purpose of bulk filling inspection on the packaging line?

14.06.2021 | QUESTION OF THE WEEK

What task do code readers have on a packaging line?

31.05.2021 | QUESTION OF THE WEEK

What does line clearance mean?

17.05.2021 | QUESTION OF THE WEEK

Which GMP inspection types can be distinguished?

03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?

19.04.2021 | QUESTION OF THE WEEK

What is the purpose of a general GMP inspection?

05.04.2021 | QUESTION OF THE WEEK

In which countries do the GMP rules for active ingredients according to ICH Q7 apply?

22.03.2021 | QUESTION OF THE WEEK

What should you bear in mind when maintaining rooms?

08.03.2021 | QUESTION OF THE WEEK

Which metrics should be looked at when reviewing the status of a site?

22.02.2021 | QUESTION OF THE WEEK

What does a company that has incorporated a proactive compliance program look like?

08.02.2021 | QUESTION OF THE WEEK

How do you determine the frequency of self-inspections?

25.01.2021 | QUESTION OF THE WEEK

What is an excipient?

11.01.2021 | QUESTION OF THE WEEK

To which areas does the self-inspection refer?

21.12.2020 | QUESTION OF THE WEEK

What is an active pharmaceutical ingredient (API)?

07.12.2020 | QUESTION OF THE WEEK

How does electro-deionisation work?

23.11.2020 | QUESTION OF THE WEEK

What is a fishbone diagram used for?

09.11.2020 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?

26.10.2020 | QUESTION OF THE WEEK

What is an informal QRM method?

12.10.2020 | QUESTION OF THE WEEK

How does a risk assessment work?

28.09.2020 | QUESTION OF THE WEEK

What role does quality risk management play in the quality management system?

14.09.2020 | QUESTION OF THE WEEK

What are the requirements for successful quality risk management (QRM)?

31.08.2020 | QUESTION OF THE WEEK

What are the advantages and benefits of quality risk management (QRM)?

17.08.2020 | QUESTION OF THE WEEK

What has to be considered for risk management?

03.08.2020 | QUESTION OF THE WEEK

What is a risk?

20.07.2020 | QUESTION OF THE WEEK

What is an action limit, and what happens when it is exceeded?

06.07.2020 | QUESTION OF THE WEEK

What is commissioning?

22.06.2020 | QUESTION OF THE WEEK

What is metrology?

08.06.2020 | QUESTION OF THE WEEK

What does official calibration mean?

25.05.2020 | QUESTION OF THE WEEK

What is meant by adjustment?

11.05.2020 | QUESTION OF THE WEEK

What does calibration mean?

27.04.2020 | QUESTION OF THE WEEK

What is meant by measurement chain?

13.04.2020 | QUESTION OF THE WEEK

Which criteria shoud be used for the selection of insulated transport boxes?

30.03.2020 | QUESTION OF THE WEEK

What is meant by cleanroom equipment?

16.03.2020 | QUESTION OF THE WEEK

Which test is used to determine the conductivity of pharmaceutical water qualities?

02.03.2020 | QUESTION OF THE WEEK

For what purposes can drinking water be used in the pharmaceutical industry?

17.02.2020 | QUESTION OF THE WEEK

Where is a qualification according to DIN Spec. 91323 applicable?

03.02.2020 | QUESTION OF THE WEEK

What are the possible benefits of risk management in transportation?

20.01.2020 | QUESTION OF THE WEEK

How can medicinal products requiring cool transport conditions be transported?

06.01.2020 | QUESTION OF THE WEEK

Where can you find concrete information regarding "transport and temperature?"

23.12.2019 | QUESTION OF THE WEEK

Why is temperature a critical aspect in transportation?

09.12.2019 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?

25.11.2019 | QUESTION OF THE WEEK

What is a training profile?

11.11.2019 | QUESTION OF THE WEEK

What is a root cause?

28.10.2019 | QUESTION OF THE WEEK

What is the difference between a direct cause and a contributing cause of failure?

14.10.2019 | QUESTION OF THE WEEK

What is industrial hygiene?

30.09.2019 | QUESTION OF THE WEEK

Which countries are covered by the British Pharmacopoeia?

16.09.2019 | QUESTION OF THE WEEK

Do European Pharmacopoeia methods need to be validated by the user?

02.09.2019 | QUESTION OF THE WEEK

Do USP methods need to be validated by the user?

19.08.2019 | QUESTION OF THE WEEK

What is the link between the European and the British Pharmacopoeia?

05.08.2019 | QUESTION OF THE WEEK

What is the legal status of the the European Pharmacopoeia?

22.07.2019 | QUESTION OF THE WEEK

What is adjustment?

08.07.2019 | QUESTION OF THE WEEK

Why is a system suitability test (SST) performed in addition to equipment qualification?

24.06.2019 | QUESTION OF THE WEEK

Which criteria are to be considered when selecting cleaning agents?

10.06.2019 | QUESTION OF THE WEEK

Why should OQ tests cover the entire working range of the equipment?

27.05.2019 | QUESTION OF THE WEEK

Which are the key aspects of personnel hygiene?

13.05.2019 | QUESTION OF THE WEEK

What are the so-called safety features on packaging materials?

29.04.2019 | QUESTION OF THE WEEK

How can a uniform colouring of secondary packaging materials be achieved?

15.04.2019 | QUESTION OF THE WEEK

What are print data for secondary packaging materials?

01.04.2019 | QUESTION OF THE WEEK

Is it acceptable to use a transport trolley for material transfer from one cleanliness class to another?

18.03.2019 | QUESTION OF THE WEEK

What are the major trends that have changed the concept of validation recently?

04.03.2019 | QUESTION OF THE WEEK

What is the advantage of Building Information Modeling (BIM) for planning new premises?

18.02.2019 | QUESTION OF THE WEEK

What is the difference between a bubble type and a sink type pressure cascade?

04.02.2019 | QUESTION OF THE WEEK

What is meant by the term "metadata"?

21.01.2019 | QUESTION OF THE WEEK

What is the significance of growth controls in microbiological monitoring?

07.01.2019 | QUESTION OF THE WEEK

Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?

24.12.2018 | QUESTION OF THE WEEK

What is the significance of an action level?

10.12.2018 | QUESTION OF THE WEEK

What is the significance of an alert level?

26.11.2018 | QUESTION OF THE WEEK

Welche Anforderung wird an ein Auftragslabor gestellt, das neben der Prüfung auch eine Freigabe durchführt?

05.11.2018 | QUESTION OF THE WEEK

Welche Bedeutung haben Ionenaustauscher bei der Pharmawasseraufbereitung?

22.10.2018 | QUESTION OF THE WEEK

Was ist Ultrafiltration und wofür wird sie eingesetzt?

03.09.2018 | QUESTION OF THE WEEK

Welche Maßnahmen beinhaltet die Instandhaltung?