Question of the Week

10.11.2025

What are the individual steps of an efficient QRM process?

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24.11.2025

How is a QRM process initiated?

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08.12.2025

What should be considered in risk assessment?

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22.12.2025

What are the quality requirements for pharmaceutical gases?

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05.01.2026

What are the requirements for gas distribution systems?

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19.01.2026

What is a gas?

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17.02.2025

What is a Certificate of Analysis (COA)?

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15.09.2025

What is essential for the structure of container closure systems used for product packaging?

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06.03.2023

What are the elements of a computerised system?

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25.03.2019

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

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05.07.2021

What is the purpose of line clearance?

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25.11.2019

What is a training profile?

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06.04.2020

What is the purpose of a measurement point risk analysis?

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17.06.2024

What does the catchphrase "Supply Chain Integrity" mean?

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25.07.2022

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

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31.08.2020

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

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13.11.2023

Who is responsible for qualification?

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29.06.2020

What is monitoring?

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17.04.2023

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

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23.01.2023

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

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08.07.2019

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

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16.03.2020

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

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09.06.2025

What is a validation test?

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14.03.2022

How do files and dossiers differ from each other?

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23.12.2024

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

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14.11.2022

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

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12.09.2022

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

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03.02.2025

What does Annual (Product) Review mean?

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12.12.2022

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

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28.09.2020

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

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16.11.2020

How do you ensure the traceability of the batch documentation?

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02.12.2024

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

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03.03.2025

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

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24.05.2021

For what purposes are insulators used?

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27.05.2024

What is adjustment?

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01.07.2024

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

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05.06.2023

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

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26.09.2022

What are endotoxins?

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11.03.2019

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

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11.01.2021

To which areas does the self-inspection refer?

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21.07.2025

What information should be covered by the validation report?

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01.08.2022

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

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14.08.2023

What general hygiene measures need to be observed?

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20.07.2020

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

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12.06.2023

What are the concepts for protecting clean work areas?

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27.10.2025

How should change management be documented?

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28.08.2023

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

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18.02.2019

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

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22.03.2021

What should you bear in mind when maintaining rooms?

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25.05.2020

What is meant by adjustment?

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12.10.2020

How does a risk assessment work?

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29.01.2024

What has to be considered when releasing batches with deviations?

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10.05.2021

What are the powers of the GMP inspectors in inspections?

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11.10.2021

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

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18.12.2023

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

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01.02.2021

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

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07.08.2023

What are the risks associated with microbiological monitoring?

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30.08.2021

What is the goal of supplier qualification?

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23.05.2022

What formal aspects help to improve the readability of SOPs?

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23.08.2021

What is the purpose of a qualification audit?

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13.12.2021

What is the purpose of stability testing?

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25.03.2024

How do you develop a process management and control strategy?

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29.07.2019

What is the objective of laboratory equipment qualification?

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29.05.2023

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

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10.08.2020

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

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30.01.2023

What are the objectives of personnel medical examinations?

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14.12.2020

What is the purpose of self-inspections?

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02.11.2020

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

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19.09.2022

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?

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21.11.2022

What is a static form?

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04.03.2024

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

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30.11.2020

What does reworking mean in the production of APIs?

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14.10.2024

What types of cabinets are available?

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20.01.2025

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

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15.07.2024

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

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23.12.2019

Why is temperature a critical aspect in transportation?

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04.09.2023

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

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08.05.2023

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

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21.03.2022

What is the function of metadata for document management?

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17.05.2021

Which GMP inspection types can be distinguished?

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25.12.2023

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

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08.07.2024

Which phases characterise the life cycle of a computerised system?

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18.05.2020

What types of requalification are distinguished?

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03.07.2023

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

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30.05.2022

What types of CIP systems are used in practice?

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03.02.2020

What are the possible benefits of risk management in transportation?

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22.02.2021

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

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24.02.2025

What means Limit of Quantitation (LOQ)?

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12.03.2023

What contracts are usually concluded in outsourcing?

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11.05.2020

What does calibration mean?

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29.03.2021

What activities does the distribution of active ingredients involve?

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07.07.2025

What information should be included in the validation plan?

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28.10.2019

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

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14.02.2022

What is an ASMF?

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11.04.2022

What are the 6 different types of Excel applications?

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19.12.2022

What is meant by import?

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10.12.2018

What is the significance of an alert level?

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22.01.2024

What is the purpose of process visualisation?

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24.06.2024

What does reprocessing mean in the production of APIs?

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11.11.2024

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

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28.11.2022

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

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26.08.2019

What is calibration?

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20.11.2023

How should one handle qualification data?

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08.08.2022

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

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06.02.2023

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

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17.01.2022

What are the 3 designs for counterfeit-proof features?

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09.03.2020

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

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11.12.2023

What factors influence cleaning?

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18.10.2021

What is a computerised system?

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01.06.2020

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

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27.07.2020

What is hygienic design?

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17.12.2018

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

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11.03.2024

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

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20.05.2024

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

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06.06.2022

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

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20.12.2021

What is an end-to-end verification system?

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16.12.2024

What information must be included in the microbiological monitoring plan?

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30.12.2024

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

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28.03.2022

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

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07.09.2020

What are complexing agents and how do they work?

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05.04.2021

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

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18.09.2023

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

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10.07.2023

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

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23.06.2025

Why do analytical test methods need to be validated?

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24.12.2018

What is the significance of an action level?

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02.09.2019

Do USP methods need to be validated by the user?

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06.07.2020

What is commissioning?

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30.12.2019

What is DIN Spec 91323?

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16.12.2019

What are the central tasks of logistics?

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07.10.2019

Who is responsible for planning and implementing cleaning validation?

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18.04.2022

Which categories of documents do the EU GMP Guidelines identify?

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20.03.2023

What is the validation of a computerised system?

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18.01.2021

Who developed the fishbone diagram?

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06.11.2023

What is the importance of plant design for qualification?

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31.05.2021

What does line clearance mean?

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10.02.2020

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

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03.10.2022

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

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09.09.2019

What is gauging?

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01.01.2024

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

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20.04.2020

What data is monitored when monitoring a HVAC system?

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15.08.2022

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

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04.08.2025

What determines the level of effort, rigour and formality with which QRM is applied?

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01.04.2019

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

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13.06.2022

Which spray heads can be used in CIP systems?

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07.10.2024

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

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04.01.2021

How does ultrafiltration work?

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16.09.2024

What special factors need to be considered for sterile filtration? (2024)

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16.09.2019

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

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15.04.2019

What are print data for secondary packaging materials?

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13.02.2023

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

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26.08.2024

How can a sterilisation process be checked?

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15.01.2024

What is a deviation?

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27.11.2023

How should the qualification be documented?

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09.12.2024

How is a physicochemical monitoring program structured?

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21.12.2020

What is an active pharmaceutical ingredient (API)?

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29.04.2024

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

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08.04.2019

What is the disadvantage of a sit-over bench?

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12.02.2024

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

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31.12.2018

What is a training profile? (2018)

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19.10.2020

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

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12.07.2021

How are deviations defined?

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21.02.2022

What is meant by archiving?

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04.11.2019

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

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02.03.2020

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

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03.06.2019

Who is responsible for generating the PQ protocols?

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27.03.2023

What are immunological medicinal products?

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07.12.2020

How does electro-deionisation work?

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22.04.2019

What is meant by serialisation?

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19.08.2019

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

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12.04.2021

What are the steps of an inspection procedure?

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07.06.2021

What is an OEL value?

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02.10.2023

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

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24.03.2025

What options are there for evaluating the Quality System?

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28.10.2024

What is the EMA and what tasks does it fulfil?

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23.03.2020

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

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02.08.2021

What is RAN and what is its purpose?

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08.06.2020

What does official calibration mean?

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05.12.2022

What are the advantages of a dynamic e-form?

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07.01.2019

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

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30.10.2023

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

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04.04.2022

What must the data owner ensure regarding data archiving?

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24.07.2023

Which metrics are subject to monitoring?

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08.01.2024

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

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21.08.2023

What is an alert limit?

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20.06.2022

What is a verified copy?

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10.02.2025

What is a Biosafety Level (BSL)?

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10.10.2022

What are the main tasks of the Head of Production?

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25.04.2022

What is a true copy?

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13.05.2024

What quality requirements must pure steam meet?

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19.06.2023

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

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06.01.2020

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

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09.01.2023

How can the suitability of premises be verified?

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12.08.2019

What does commissioning mean?

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22.06.2020

What is metrology?

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04.11.2024

What is the EDQM and what are its tasks?

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18.03.2024

For what purposes are isolators used?

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20.02.2023

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

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15.02.2021

What are the advantages of using Ultrafiltration?

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16.08.2021

What is a shared audit?

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01.04.2024

What must be observed when working with gloves in isolators?

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02.01.2023

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

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10.06.2019

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

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26.06.2023

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

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08.04.2024

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

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09.09.2024

What requirements are placed on cleanroom personnel?

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27.06.2022

Where do SOPs need to be available?

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04.07.2022

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

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25.01.2021

What is an excipient?

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17.08.2020

What has to be considered for risk management?

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09.08.2021

What is pharmacovigilance?

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19.04.2021

What is the purpose of a general GMP inspection?

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24.01.2022

What is meant by registration or authorisation batches?

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23.10.2023

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

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14.09.2020

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

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30.09.2019

Which countries are covered by the British Pharmacopoeia?

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03.01.2022

What is the official document containing official actions sent by the FDA after a GMP inspection called? (2022)

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29.04.2019

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

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30.03.2020

What is meant by cleanroom equipment?

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14.06.2021

What task do code readers have on a packaging line?

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13.09.2021

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

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02.05.2022

To whom are SOPs addressed?

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01.07.2019

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

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14.10.2019

What is industrial hygiene?

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15.06.2020

What phases are involved in planning a construction project?

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24.04.2023

What is the qualification of a computerised system?

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12.08.2024

What are the legal requirements for plastics?

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13.10.2025

In which areas should change management be applied and who is responsible for implementation?

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27.04.2020

What is meant by measurement chain?

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17.10.2022

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

Here's the answer:

19.07.2021

What is the European safety referral used for?

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28.04.2025

What advantages does quality risk management have for the company?

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14.01.2019

What is the minimum requirement for cleaned equipment?

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25.10.2021

What is an Establishment Inspection Report (EIR)?

Here's the answer:

28.02.2022

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

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01.05.2023

What is the purpose of a responsibility matrix?

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17.06.2019

How should raw data be handled?

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11.11.2019

What is a root cause?

Here's the answer:

08.02.2021

How do you determine the frequency of self-inspections?

Here's the answer:

03.04.2023

What is the verification of a computerised system?

Here's the answer:

13.01.2020

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

Here's the answer:

31.07.2023

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

Here's the answer:

20.09.2021

When is a for-cause audit required?

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27.01.2025

What are endotoxins and what are their effects?

Here's the answer:

22.08.2022

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

Here's the answer:

10.03.2025

How are responsibilities split between Quality Control and Quality Assurance?

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10.04.2023

What is the difference between strategic and tactical outsourcing?

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05.08.2019

What is the legal status of the European Pharmacopoeia?

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26.05.2025

What do the abbreviations VP and VR mean?

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19.08.2024

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

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17.02.2020

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

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13.07.2020

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

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11.07.2022

What is a Batch Record Review?

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25.09.2023

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

Here's the answer:

09.11.2020

What does reprocessing mean in the production of APIs? (2020)

Here's the answer:

09.05.2022

What has to be considered in risk management?

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24.06.2019

Which criteria are to be considered when selecting cleaning agents?

Here's the answer:

15.07.2019

What is the Design Qualification?

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17.03.2025

What does quality oversight mean?

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24.10.2022

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

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21.01.2019

What is the significance of growth controls in microbiological monitoring?

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08.03.2021

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

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27.09.2021

What is meant by offshoring?

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04.12.2023

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

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23.09.2024

What needs to be considered when validating a sterility test method? (2024)

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26.10.2020

What is an informal QRM method?

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22.05.2023

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

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18.08.2025

What is required for risk-based decision-making?

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16.01.2023

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

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09.10.2023

What cleaning validation sampling procedures are available for which residues?

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01.09.2025

How can subjectivity in the QRM process be minimized?

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26.04.2021

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

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29.07.2024

Which lubricants can be used in a GMP environment?

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21.10.2024

Which parameters are relevant in the monitoring of pharmaceutical water?

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24.08.2020

What is a residual risk?

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06.05.2019

What is the advantage of a 2D-MatrixCode?

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12.05.2025

What are the phases of the quality risk management process?

Here's the answer:

29.08.2022

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

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17.07.2023

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

Here's the answer:

21.06.2021

What significance do OEBs have?

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26.07.2021

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

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27.02.2023

Which active ingredient manufacturers receive an EU GMP certificate?

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28.01.2019

Is it necessary to wear gloves in cleanroom class D?

Here's the answer:

25.02.2019

Which role plays a runner during an inspection?

Here's the answer:

05.10.2020

How can UV irradiation be used in pharmaceutical water generation?

Here's the answer:

11.09.2023

What is an action limit?

Here's the answer:

18.11.2019

Which general requirement applies to the design of material locks?

Here's the answer:

21.09.2020

In which phases is the quality risk management process divided?

Here's the answer:

06.12.2021

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

Here's the answer:

24.02.2020

What guidelines and quality standards apply to airfreight?

Here's the answer:

13.05.2019

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

Here's the answer:

15.05.2023

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

Here's the answer:

16.05.2022

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

Here's the answer:

03.08.2020

What is a risk?

Here's the answer:

31.01.2022

What is an API Starting Material?

Here's the answer:

22.07.2024

Which different types of stainless steel are available?

Here's the answer:

16.10.2023

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

Here's the answer:

03.06.2024

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

Here's the answer:

07.03.2022

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

Here's the answer:

27.01.2020

What is meant by active and passive temperature control?

Here's the answer:

31.10.2022

What are the advantages of integrated qualification?

Here's the answer:

04.10.2021

What is IT governance?

Here's the answer:

18.07.2022

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

Here's the answer:

01.03.2021

How are self-inspections documented?

Here's the answer:

10.01.2022

What is a stability commitment?

Here's the answer:

05.08.2024

What should be considered when selecting a suitable sealing material?

Here's the answer:

20.05.2019

What is the difference between an EDMS and an EQMS?

Here's the answer:

28.06.2021

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

Here's the answer:

22.04.2024

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

Here's the answer:

06.09.2021

What is a third-party audit?

Here's the answer:

04.02.2019

What is meant by the term "metadata"?

Here's the answer:

20.01.2020

How can medicinal products requiring cool transport conditions be transported?

Here's the answer:

13.01.2025

How is pure steam produced and used?

Here's the answer:

05.02.2024

What is cloud computing?

Here's the answer:

26.02.2024

What do typical manufacturing processes look like?

Here's the answer:

23.11.2020

What is a fishbone diagram used for?

Here's the answer:

06.05.2024

What are the basic physical principles of steam generation?

Here's the answer:

13.04.2020

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

Here's the answer:

15.04.2024

What was the reason for the revision of Annex 1?

Here's the answer:

21.10.2019

What does a challenge-concept for cleaning validation mean?

Here's the answer:

18.11.2024

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

Here's the answer:

05.09.2022

What water quality do you use for cold WFI production?

Here's the answer:

07.02.2022

What are the requirements for advanced electronic signatures?

Here's the answer:

18.03.2019

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

Here's the answer:

06.01.2025

What are the different types of pharmaceutical water?

Here's the answer:

27.05.2019

Which are the key aspects of personnel hygiene?

Here's the answer:

15.03.2021

What is important for the processing of deviations?

Here's the answer:

31.03.2025

How do we deal with risks?

Here's the answer:

04.05.2020

What is confirmed by an ATP certificate?

Here's the answer:

10.06.2024

What is DIN Spec. 91323?

Here's the answer:

29.09.2025

What methods are used for testing leakage?

Here's the answer:

02.09.2024

What is the Sterility Assurance Level (SAL)?

Here's the answer:

07.11.2022

What is a generic form?

Here's the answer:

19.02.2024

What are facility control systems used for?

Here's the answer:

25.11.2024

What special factors need to be considered for sterile filtration?

Here's the answer:

03.05.2021

What is confirmed by the written confirmation for imported APIs?

Here's the answer:

14.04.2025

How can QRM be used?

Here's the answer:

29.11.2021

What is the FDA inspection report being called?

Here's the answer:

30.09.2024

Where can you find regulatory requirements for isolator technology?

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