27.05.2024

What is adjustment?

zur Antwort
20.05.2024

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

zur Antwort
13.05.2024

What quality requirements must pure steam meet?

zur Antwort
06.05.2024

What are the basic physical principles of steam generation?

zur Antwort
29.04.2024

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

zur Antwort
22.04.2024

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

zur Antwort
15.04.2024

What was the reason for the revision of Annex 1?

zur Antwort
08.04.2024

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

zur Antwort
01.04.2024

What must be observed when working with gloves in isolators?

zur Antwort
25.03.2024

How do you develop a process management and control strategy?

zur Antwort
18.03.2024

For what purposes are isolators used?

zur Antwort
11.03.2024

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

zur Antwort
04.03.2024

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

zur Antwort
26.02.2024

What do typical manufacturing processes look like?

zur Antwort
19.02.2024

What are facility control systems used for?

zur Antwort
12.02.2024

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

zur Antwort
05.02.2024

What is cloud computing?

zur Antwort
29.01.2024

What has to be considered when releasing batches with deviations?

zur Antwort
22.01.2024

What is the purpose of process visualisation?

zur Antwort
15.01.2024

What is a deviation?

zur Antwort
08.01.2024

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

zur Antwort
01.01.2024

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

zur Antwort
25.12.2023

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

zur Antwort
18.12.2023

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

zur Antwort
11.12.2023

What factors influence cleaning?

zur Antwort
04.12.2023

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

zur Antwort
27.11.2023

How should the qualification be documented?

zur Antwort
20.11.2023

How should one handle qualification data?

zur Antwort
13.11.2023

Who is responsible for qualification?

zur Antwort
06.11.2023

What is the importance of plant design for qualification?

zur Antwort
30.10.2023

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

zur Antwort
23.10.2023

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

zur Antwort
16.10.2023

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

zur Antwort
09.10.2023

What cleaning validation sampling procedures are available for which residues?

zur Antwort
02.10.2023

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

zur Antwort
25.09.2023

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

zur Antwort
18.09.2023

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

zur Antwort
11.09.2023

What is an action limit?

zur Antwort
04.09.2023

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

zur Antwort
28.08.2023

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

zur Antwort
21.08.2023

What is an alert limit?

zur Antwort
14.08.2023

What general hygiene measures need to be observed?

zur Antwort
07.08.2023

What are the risks associated with microbiological monitoring?

zur Antwort
31.07.2023

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

zur Antwort
24.07.2023

Which metrics are subject to monitoring?

zur Antwort
17.07.2023

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

zur Antwort
10.07.2023

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

zur Antwort
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?

zur Antwort
26.06.2023

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

zur Antwort
19.06.2023

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

zur Antwort