04.04.2022
What must the data owner ensure regarding data archiving?
zur Antwort
28.03.2022
From what stage in the chemical manufacturing process do GMP regulations apply?
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21.03.2022
What is the function of metadata for document management?
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14.03.2022
How do files and dossiers differ from each other?
zur Antwort
07.03.2022
What types of impurities may be present in chemical active substances?
zur Antwort
28.02.2022
What elements should be contained in a validation plan for Excel spreadsheets?
zur Antwort
07.02.2022
What are the requirements for advanced electronic signatures?
zur Antwort
31.01.2022
What is an API Starting Material?
zur Antwort
24.01.2022
What is meant by registration or authorisation batches?
zur Antwort
17.01.2022
What are the 3 designs for counterfeit-proof features?
zur Antwort
03.01.2022
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
15.11.2021
What is meant by front office and back office in the context of a GMP inspection?
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
11.10.2021
What are the most important QMS areas of a GMP inspection?
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
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
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
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
14.06.2021
What task do code readers have on a packaging line?
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?
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