17.01.2022

What is meant by registration or authorisation batches?

zur Antwort
10.01.2022

What are the 3 designs for counterfeit-proof features?

zur Antwort
03.01.2022

What is a stability commitment?

zur Antwort
27.12.2021

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

zur Antwort
20.12.2021

What is an end-to-end verification system?

zur Antwort
13.12.2021

What is the purpose of stability testing?

zur Antwort
06.12.2021

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

zur Antwort
29.11.2021

What is the FDA inspection report being called?

zur Antwort
22.11.2021

What is a black-box test?

zur Antwort
15.11.2021

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

zur Antwort
08.11.2021

What is a white-box test?

zur Antwort
01.11.2021

What is illustrated in the V model?

zur Antwort
25.10.2021

What is an Establishment Inspection Report (EIR)?

zur Antwort
18.10.2021

What is a computerised system?

zur Antwort
11.10.2021

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

zur Antwort
04.10.2021

What is IT governance?

zur Antwort
27.09.2021

What is meant by offshoring?

zur Antwort
20.09.2021

When is a for-cause audit required?

zur Antwort
13.09.2021

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

zur Antwort
06.09.2021

What is a third-party audit?

zur Antwort
30.08.2021

What is the goal of supplier qualification?

zur Antwort
23.08.2021

What is the purpose of a qualification audit?

zur Antwort
16.08.2021

What is a shared audit?

zur Antwort
09.08.2021

What is pharmacovigilance?

zur Antwort
02.08.2021

What is RAN and what is its purpose?

zur Antwort
26.07.2021

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

zur Antwort
19.07.2021

What is the European safety referral used for?

zur Antwort
12.07.2021

How are deviations defined?

zur Antwort
05.07.2021

What is the purpose of line clearance?

zur Antwort
28.06.2021

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

zur Antwort
21.06.2021

What significance do OEBs have?

zur Antwort
14.06.2021

What task do code readers have on a packaging line?

zur Antwort
07.06.2021

What is an OEL value?

zur Antwort
31.05.2021

What does line clearance mean?

zur Antwort
24.05.2021

For what purposes are insulators used?

zur Antwort
17.05.2021

Which GMP inspection types can be distinguished?

zur Antwort
10.05.2021

What are the powers of the GMP inspectors in inspections?

zur Antwort
03.05.2021

What is confirmed by the written confirmation for imported APIs?

zur Antwort
26.04.2021

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

zur Antwort
19.04.2021

What is the purpose of a general GMP inspection?

zur Antwort
12.04.2021

What are the steps of an inspection procedure?

zur Antwort
05.04.2021

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

zur Antwort
29.03.2021

What activities does the distribution of active ingredients involve?

zur Antwort
22.03.2021

What should you bear in mind when maintaining rooms?

zur Antwort
15.03.2021

What is important for the processing of deviations?

zur Antwort
08.03.2021

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

zur Antwort
01.03.2021

How are self-inspections documented?

zur Antwort
22.02.2021

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

zur Antwort
15.02.2021

What are the advantages of using Ultrafiltration?

zur Antwort
08.02.2021

How do you determine the frequency of self-inspections?

zur Antwort