GMP:Blog

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10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?


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03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?


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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?


read more ...
19.04.2021 | QUESTION OF THE WEEK

What is the purpose of a general GMP inspection?


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12.04.2021 | QUESTION OF THE WEEK

What are the steps of an inspection procedure?


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05.04.2021 | QUESTION OF THE WEEK

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


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29.03.2021 | QUESTION OF THE WEEK

What activities does the distribution of active ingredients involve?


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22.03.2021 | QUESTION OF THE WEEK

What should you bear in mind when maintaining rooms?


read more ...
15.03.2021 | QUESTION OF THE WEEK

What is important for the processing of deviations?


read more ...
08.03.2021 | QUESTION OF THE WEEK

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


read more ...
01.03.2021 | QUESTION OF THE WEEK

How are self-inspections documented?


read more ...
22.02.2021 | QUESTION OF THE WEEK

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


read more ...
15.02.2021 | QUESTION OF THE WEEK

What are the advantages of using Ultrafiltration?


read more ...
08.02.2021 | QUESTION OF THE WEEK

How do you determine the frequency of self-inspections?


read more ...
01.02.2021 | QUESTION OF THE WEEK

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


read more ...
25.01.2021 | QUESTION OF THE WEEK

What is an excipient?


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18.01.2021 | QUESTION OF THE WEEK

Who developed the fishbone diagram?


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11.01.2021 | QUESTION OF THE WEEK

To which areas does the self-inspection refer?


read more ...
04.01.2021 | QUESTION OF THE WEEK

How does ultrafiltration work?


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21.12.2020 | QUESTION OF THE WEEK

What is an active pharmaceutical ingredient (API)?


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14.12.2020 | QUESTION OF THE WEEK

What is the purpose of self-inspections?


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07.12.2020 | QUESTION OF THE WEEK

How does electro-deionisation work?


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30.11.2020 | QUESTION OF THE WEEK

What does reworking mean in the production of APIs?


read more ...
23.11.2020 | QUESTION OF THE WEEK

What is a fishbone diagram used for?


read more ...
16.11.2020 | QUESTION OF THE WEEK

How do you ensure the traceability of the batch documentation?


read more ...
09.11.2020 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?


read more ...
02.11.2020 | QUESTION OF THE WEEK

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


read more ...
26.10.2020 | QUESTION OF THE WEEK

What is an informal QRM method?


read more ...
19.10.2020 | QUESTION OF THE WEEK

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


read more ...
12.10.2020 | QUESTION OF THE WEEK

How does a risk assessment work?


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05.10.2020 | QUESTION OF THE WEEK

How can UV irradiation be used in pharmaceutical water generation?


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28.09.2020 | QUESTION OF THE WEEK

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


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21.09.2020 | QUESTION OF THE WEEK

In which phases is the quality risk management process divided?


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14.09.2020 | QUESTION OF THE WEEK

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


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07.09.2020 | QUESTION OF THE WEEK

What are complexing agents and how do they work?


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31.08.2020 | QUESTION OF THE WEEK

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


read more ...
24.08.2020 | QUESTION OF THE WEEK

What is a residual risk?


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17.08.2020 | QUESTION OF THE WEEK

What has to be considered for risk management?


read more ...
10.08.2020 | QUESTION OF THE WEEK

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


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03.08.2020 | QUESTION OF THE WEEK

What is a risk?


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27.07.2020 | QUESTION OF THE WEEK

What is hygienic design?


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20.07.2020 | QUESTION OF THE WEEK

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


read more ...
13.07.2020 | QUESTION OF THE WEEK

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


read more ...
06.07.2020 | QUESTION OF THE WEEK

What is commissioning?


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29.06.2020 | QUESTION OF THE WEEK

What is monitoring?


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22.06.2020 | QUESTION OF THE WEEK

What is metrology?


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15.06.2020 | QUESTION OF THE WEEK

What phases are involved in planning a construction project?


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08.06.2020 | QUESTION OF THE WEEK

What does official calibration mean?


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01.06.2020 | QUESTION OF THE WEEK

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


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25.05.2020 | QUESTION OF THE WEEK

What is meant by adjustment?


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18.05.2020 | QUESTION OF THE WEEK

What types of requalification are distinguished?


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11.05.2020 | QUESTION OF THE WEEK

What does calibration mean?


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04.05.2020 | QUESTION OF THE WEEK

What is confirmed by an ATP certificate?


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27.04.2020 | QUESTION OF THE WEEK

What is meant by measurement chain?


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20.04.2020 | QUESTION OF THE WEEK

What data is monitored when monitoring a HVAC system?


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13.04.2020 | QUESTION OF THE WEEK

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


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06.04.2020 | QUESTION OF THE WEEK

What is the purpose of a measurement point risk analysis?


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30.03.2020 | QUESTION OF THE WEEK

What is meant by cleanroom equipment?


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23.03.2020 | QUESTION OF THE WEEK

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


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16.03.2020 | QUESTION OF THE WEEK

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


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09.03.2020 | QUESTION OF THE WEEK

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


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02.03.2020 | QUESTION OF THE WEEK

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


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24.02.2020 | QUESTION OF THE WEEK

What guidelines and quality standards apply to airfreight?


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17.02.2020 | QUESTION OF THE WEEK

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


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10.02.2020 | QUESTION OF THE WEEK

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


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03.02.2020 | QUESTION OF THE WEEK

What are the possible benefits of risk management in transportation?


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27.01.2020 | QUESTION OF THE WEEK

What is meant by active and passive temperature control?


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20.01.2020 | QUESTION OF THE WEEK

How can medicinal products requiring cool transport conditions be transported?


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13.01.2020 | QUESTION OF THE WEEK

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


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06.01.2020 | QUESTION OF THE WEEK

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


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30.12.2019 | QUESTION OF THE WEEK

What is DIN Spec 91323?


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23.12.2019 | QUESTION OF THE WEEK

Why is temperature a critical aspect in transportation?


read more ...
16.12.2019 | QUESTION OF THE WEEK

What are the central tasks of logistics?


read more ...
09.12.2019 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?


read more ...
02.12.2019 | QUESTION OF THE WEEK

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


read more ...
25.11.2019 | QUESTION OF THE WEEK

What is a training profile?


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18.11.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?


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11.11.2019 | QUESTION OF THE WEEK

What is a root cause?


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04.11.2019 | QUESTION OF THE WEEK

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


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28.10.2019 | QUESTION OF THE WEEK

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


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21.10.2019 | QUESTION OF THE WEEK

What does a challenge-concept for cleaning validation mean?


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14.10.2019 | QUESTION OF THE WEEK

What is industrial hygiene?


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07.10.2019 | QUESTION OF THE WEEK

Who is responsible for planning and implementing cleaning validation?


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30.09.2019 | QUESTION OF THE WEEK

Which countries are covered by the British Pharmacopoeia?


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23.09.2019 | QUESTION OF THE WEEK

What is adjustment?


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16.09.2019 | QUESTION OF THE WEEK

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


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09.09.2019 | QUESTION OF THE WEEK

What is gauging?


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02.09.2019 | QUESTION OF THE WEEK

Do USP methods need to be validated by the user?


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26.08.2019 | QUESTION OF THE WEEK

What is calibration?


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19.08.2019 | QUESTION OF THE WEEK

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


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12.08.2019 | QUESTION OF THE WEEK

What is commissioning?


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05.08.2019 | QUESTION OF THE WEEK

What is the legal status of the the European Pharmacopoeia?


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29.07.2019 | QUESTION OF THE WEEK

What is the objective of laboratory equipment qualification?


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22.07.2019 | QUESTION OF THE WEEK

What is adjustment?


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15.07.2019 | QUESTION OF THE WEEK

What is the Design Qualification?


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08.07.2019 | QUESTION OF THE WEEK

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


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01.07.2019 | QUESTION OF THE WEEK

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


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24.06.2019 | QUESTION OF THE WEEK

Which criteria are to be considered when selecting cleaning agents?


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17.06.2019 | QUESTION OF THE WEEK

How should raw data be handled?


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10.06.2019 | QUESTION OF THE WEEK

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


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03.06.2019 | QUESTION OF THE WEEK

Who is responsible for generating the PQ protocols?


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27.05.2019 | QUESTION OF THE WEEK

Which are the key aspects of personnel hygiene?


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20.05.2019 | QUESTION OF THE WEEK

What is the difference between an EDMS and an EQMS?


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13.05.2019 | QUESTION OF THE WEEK

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


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06.05.2019 | QUESTION OF THE WEEK

What is the advantage of a 2D-MatrixCode?


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29.04.2019 | QUESTION OF THE WEEK

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


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22.04.2019 | QUESTION OF THE WEEK

What is meant by serialisation?


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15.04.2019 | QUESTION OF THE WEEK

What are print data for secondary packaging materials?


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08.04.2019 | QUESTION OF THE WEEK

What is the disadvantage of a sit-over bench?


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01.04.2019 | QUESTION OF THE WEEK

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


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25.03.2019 | QUESTION OF THE WEEK

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


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18.03.2019 | QUESTION OF THE WEEK

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


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11.03.2019 | QUESTION OF THE WEEK

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


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04.03.2019 | QUESTION OF THE WEEK

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


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25.02.2019 | QUESTION OF THE WEEK

Which role plays a runner during an inspection?


read more ...
18.02.2019 | QUESTION OF THE WEEK

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


read more ...
11.02.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?


read more ...
04.02.2019 | QUESTION OF THE WEEK

What is meant by the term "metadata"?


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28.01.2019 | QUESTION OF THE WEEK

Is it necessary to wear gloves in cleanroom class D?


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21.01.2019 | QUESTION OF THE WEEK

What is the significance of growth controls in microbiological monitoring?


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14.01.2019 | QUESTION OF THE WEEK

What is the minimum requirement for cleaned equipment?


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07.01.2019 | QUESTION OF THE WEEK

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


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31.12.2018 | QUESTION OF THE WEEK

What is a training profile?


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24.12.2018 | QUESTION OF THE WEEK

What is the significance of an action level?


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17.12.2018 | QUESTION OF THE WEEK

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


read more ...
10.12.2018 | QUESTION OF THE WEEK

What is the significance of an alert level?


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03.12.2018 | QUESTION OF THE WEEK

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


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26.11.2018 | QUESTION OF THE WEEK

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


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19.11.2018 | QUESTION OF THE WEEK

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


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05.11.2018 | QUESTION OF THE WEEK

Welche Bedeutung haben Ionenaustauscher bei der Pharmawasseraufbereitung?


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29.10.2018 | QUESTION OF THE WEEK

Für welche Zwecke werden UV-Strahler in Wasseraufbereitungsanlagen eingesetzt?


read more ...
22.10.2018 | QUESTION OF THE WEEK

Was ist Ultrafiltration und wofür wird sie eingesetzt?


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10.09.2018 | QUESTION OF THE WEEK

Wie ist die Instandhaltungsrate definiert?


read more ...
03.09.2018 | QUESTION OF THE WEEK

Welche Maßnahmen beinhaltet die Instandhaltung?


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27.08.2018 | QUESTION OF THE WEEK

Welche Aufgabe erfüllt die Instandhaltung?


read more ...
10.05.2021 | QUESTION OF THE WEEK

What are the powers of the GMP inspectors in inspections?


read more ...
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?


read more ...
12.04.2021 | QUESTION OF THE WEEK

What are the steps of an inspection procedure?


read more ...
29.03.2021 | QUESTION OF THE WEEK

What activities does the distribution of active ingredients involve?


read more ...
15.03.2021 | QUESTION OF THE WEEK

What is important for the processing of deviations?


read more ...
01.03.2021 | QUESTION OF THE WEEK

How are self-inspections documented?


read more ...
15.02.2021 | QUESTION OF THE WEEK

What are the advantages of using Ultrafiltration?


read more ...
01.02.2021 | QUESTION OF THE WEEK

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


read more ...
18.01.2021 | QUESTION OF THE WEEK

Who developed the fishbone diagram?


read more ...
04.01.2021 | QUESTION OF THE WEEK

How does ultrafiltration work?


read more ...
14.12.2020 | QUESTION OF THE WEEK

What is the purpose of self-inspections?


read more ...
30.11.2020 | QUESTION OF THE WEEK

What does reworking mean in the production of APIs?


read more ...
16.11.2020 | QUESTION OF THE WEEK

How do you ensure the traceability of the batch documentation?


read more ...
02.11.2020 | QUESTION OF THE WEEK

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


read more ...
19.10.2020 | QUESTION OF THE WEEK

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


read more ...
05.10.2020 | QUESTION OF THE WEEK

How can UV irradiation be used in pharmaceutical water generation?


read more ...
21.09.2020 | QUESTION OF THE WEEK

In which phases is the quality risk management process divided?


read more ...
07.09.2020 | QUESTION OF THE WEEK

What are complexing agents and how do they work?


read more ...
24.08.2020 | QUESTION OF THE WEEK

What is a residual risk?


read more ...
10.08.2020 | QUESTION OF THE WEEK

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


read more ...
27.07.2020 | QUESTION OF THE WEEK

What is hygienic design?


read more ...
13.07.2020 | QUESTION OF THE WEEK

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


read more ...
29.06.2020 | QUESTION OF THE WEEK

What is monitoring?


read more ...
15.06.2020 | QUESTION OF THE WEEK

What phases are involved in planning a construction project?


read more ...
01.06.2020 | QUESTION OF THE WEEK

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


read more ...
18.05.2020 | QUESTION OF THE WEEK

What types of requalification are distinguished?


read more ...
04.05.2020 | QUESTION OF THE WEEK

What is confirmed by an ATP certificate?


read more ...
20.04.2020 | QUESTION OF THE WEEK

What data is monitored when monitoring a HVAC system?


read more ...
06.04.2020 | QUESTION OF THE WEEK

What is the purpose of a measurement point risk analysis?


read more ...
23.03.2020 | QUESTION OF THE WEEK

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


read more ...
09.03.2020 | QUESTION OF THE WEEK

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


read more ...
24.02.2020 | QUESTION OF THE WEEK

What guidelines and quality standards apply to airfreight?


read more ...
10.02.2020 | QUESTION OF THE WEEK

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


read more ...
27.01.2020 | QUESTION OF THE WEEK

What is meant by active and passive temperature control?


read more ...
13.01.2020 | QUESTION OF THE WEEK

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


read more ...
30.12.2019 | QUESTION OF THE WEEK

What is DIN Spec 91323?


read more ...
16.12.2019 | QUESTION OF THE WEEK

What are the central tasks of logistics?


read more ...
02.12.2019 | QUESTION OF THE WEEK

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


read more ...
18.11.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?


read more ...
04.11.2019 | QUESTION OF THE WEEK

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


read more ...
21.10.2019 | QUESTION OF THE WEEK

What does a challenge-concept for cleaning validation mean?


read more ...
07.10.2019 | QUESTION OF THE WEEK

Who is responsible for planning and implementing cleaning validation?


read more ...
23.09.2019 | QUESTION OF THE WEEK

What is adjustment?


read more ...
09.09.2019 | QUESTION OF THE WEEK

What is gauging?


read more ...
26.08.2019 | QUESTION OF THE WEEK

What is calibration?


read more ...
12.08.2019 | QUESTION OF THE WEEK

What is commissioning?


read more ...
29.07.2019 | QUESTION OF THE WEEK

What is the objective of laboratory equipment qualification?


read more ...
15.07.2019 | QUESTION OF THE WEEK

What is the Design Qualification?


read more ...
01.07.2019 | QUESTION OF THE WEEK

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


read more ...
17.06.2019 | QUESTION OF THE WEEK

How should raw data be handled?


read more ...
03.06.2019 | QUESTION OF THE WEEK

Who is responsible for generating the PQ protocols?


read more ...
20.05.2019 | QUESTION OF THE WEEK

What is the difference between an EDMS and an EQMS?


read more ...
06.05.2019 | QUESTION OF THE WEEK

What is the advantage of a 2D-MatrixCode?


read more ...
22.04.2019 | QUESTION OF THE WEEK

What is meant by serialisation?


read more ...
08.04.2019 | QUESTION OF THE WEEK

What is the disadvantage of a sit-over bench?


read more ...
25.03.2019 | QUESTION OF THE WEEK

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


read more ...
11.03.2019 | QUESTION OF THE WEEK

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


read more ...
25.02.2019 | QUESTION OF THE WEEK

Which role plays a runner during an inspection?


read more ...
11.02.2019 | QUESTION OF THE WEEK

Which general requirement applies to the design of material locks?


read more ...
28.01.2019 | QUESTION OF THE WEEK

Is it necessary to wear gloves in cleanroom class D?


read more ...
14.01.2019 | QUESTION OF THE WEEK

What is the minimum requirement for cleaned equipment?


read more ...
31.12.2018 | QUESTION OF THE WEEK

What is a training profile?


read more ...
17.12.2018 | QUESTION OF THE WEEK

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


read more ...
03.12.2018 | QUESTION OF THE WEEK

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


read more ...
19.11.2018 | QUESTION OF THE WEEK

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


read more ...
29.10.2018 | QUESTION OF THE WEEK

Für welche Zwecke werden UV-Strahler in Wasseraufbereitungsanlagen eingesetzt?


read more ...
10.09.2018 | QUESTION OF THE WEEK

Wie ist die Instandhaltungsrate definiert?


read more ...
27.08.2018 | QUESTION OF THE WEEK

Welche Aufgabe erfüllt die Instandhaltung?


read more ...
03.05.2021 | QUESTION OF THE WEEK

What is confirmed by the written confirmation for imported APIs?


read more ...
19.04.2021 | QUESTION OF THE WEEK

What is the purpose of a general GMP inspection?


read more ...
05.04.2021 | QUESTION OF THE WEEK

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


read more ...
22.03.2021 | QUESTION OF THE WEEK

What should you bear in mind when maintaining rooms?


read more ...
08.03.2021 | QUESTION OF THE WEEK

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


read more ...
22.02.2021 | QUESTION OF THE WEEK

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


read more ...
08.02.2021 | QUESTION OF THE WEEK

How do you determine the frequency of self-inspections?


read more ...
25.01.2021 | QUESTION OF THE WEEK

What is an excipient?


read more ...
11.01.2021 | QUESTION OF THE WEEK

To which areas does the self-inspection refer?


read more ...
21.12.2020 | QUESTION OF THE WEEK

What is an active pharmaceutical ingredient (API)?


read more ...
07.12.2020 | QUESTION OF THE WEEK

How does electro-deionisation work?


read more ...
23.11.2020 | QUESTION OF THE WEEK

What is a fishbone diagram used for?


read more ...
09.11.2020 | QUESTION OF THE WEEK

What does reprocessing mean in the production of APIs?


read more ...
26.10.2020 | QUESTION OF THE WEEK

What is an informal QRM method?


read more ...
12.10.2020 | QUESTION OF THE WEEK

How does a risk assessment work?


read more ...
28.09.2020 | QUESTION OF THE WEEK

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


read more ...
14.09.2020 | QUESTION OF THE WEEK

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


read more ...
31.08.2020 | QUESTION OF THE WEEK

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


read more ...
17.08.2020 | QUESTION OF THE WEEK

What has to be considered for risk management?


read more ...
03.08.2020 | QUESTION OF THE WEEK

What is a risk?


read more ...
20.07.2020 | QUESTION OF THE WEEK

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


read more ...
06.07.2020 | QUESTION OF THE WEEK

What is commissioning?


read more ...
22.06.2020 | QUESTION OF THE WEEK

What is metrology?


read more ...
08.06.2020 | QUESTION OF THE WEEK

What does official calibration mean?


read more ...
25.05.2020 | QUESTION OF THE WEEK

What is meant by adjustment?


read more ...
11.05.2020 | QUESTION OF THE WEEK

What does calibration mean?


read more ...
27.04.2020 | QUESTION OF THE WEEK

What is meant by measurement chain?


read more ...
13.04.2020 | QUESTION OF THE WEEK

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


read more ...
30.03.2020 | QUESTION OF THE WEEK

What is meant by cleanroom equipment?


read more ...
16.03.2020 | QUESTION OF THE WEEK

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


read more ...
02.03.2020 | QUESTION OF THE WEEK

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


read more ...
17.02.2020 | QUESTION OF THE WEEK

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


read more ...
03.02.2020 | QUESTION OF THE WEEK

What are the possible benefits of risk management in transportation?


read more ...
20.01.2020 | QUESTION OF THE WEEK

How can medicinal products requiring cool transport conditions be transported?


read more ...
06.01.2020 | QUESTION OF THE WEEK

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


read more ...
23.12.2019 | QUESTION OF THE WEEK

Why is temperature a critical aspect in transportation?


read more ...
09.12.2019 | QUESTION OF THE WEEK

What does the catchphrase "Supply Chain Integrity" mean?


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25.11.2019 | QUESTION OF THE WEEK

What is a training profile?


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11.11.2019 | QUESTION OF THE WEEK

What is a root cause?


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28.10.2019 | QUESTION OF THE WEEK

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


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14.10.2019 | QUESTION OF THE WEEK

What is industrial hygiene?


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30.09.2019 | QUESTION OF THE WEEK

Which countries are covered by the British Pharmacopoeia?


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16.09.2019 | QUESTION OF THE WEEK

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


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02.09.2019 | QUESTION OF THE WEEK

Do USP methods need to be validated by the user?


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19.08.2019 | QUESTION OF THE WEEK

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


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05.08.2019 | QUESTION OF THE WEEK

What is the legal status of the the European Pharmacopoeia?


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22.07.2019 | QUESTION OF THE WEEK

What is adjustment?


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08.07.2019 | QUESTION OF THE WEEK

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


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24.06.2019 | QUESTION OF THE WEEK

Which criteria are to be considered when selecting cleaning agents?


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10.06.2019 | QUESTION OF THE WEEK

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


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27.05.2019 | QUESTION OF THE WEEK

Which are the key aspects of personnel hygiene?


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13.05.2019 | QUESTION OF THE WEEK

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


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29.04.2019 | QUESTION OF THE WEEK

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


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15.04.2019 | QUESTION OF THE WEEK

What are print data for secondary packaging materials?


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01.04.2019 | QUESTION OF THE WEEK

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


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18.03.2019 | QUESTION OF THE WEEK

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


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04.03.2019 | QUESTION OF THE WEEK

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


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18.02.2019 | QUESTION OF THE WEEK

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


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04.02.2019 | QUESTION OF THE WEEK

What is meant by the term "metadata"?


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21.01.2019 | QUESTION OF THE WEEK

What is the significance of growth controls in microbiological monitoring?


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07.01.2019 | QUESTION OF THE WEEK

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


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24.12.2018 | QUESTION OF THE WEEK

What is the significance of an action level?


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10.12.2018 | QUESTION OF THE WEEK

What is the significance of an alert level?


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26.11.2018 | QUESTION OF THE WEEK

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


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05.11.2018 | QUESTION OF THE WEEK

Welche Bedeutung haben Ionenaustauscher bei der Pharmawasseraufbereitung?


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22.10.2018 | QUESTION OF THE WEEK

Was ist Ultrafiltration und wofür wird sie eingesetzt?


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03.09.2018 | QUESTION OF THE WEEK

Welche Maßnahmen beinhaltet die Instandhaltung?


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