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?
zur Antwort
12.09.2022
How do APR and PQR differ in terms of the number of batches to be assessed in the review period?
zur Antwort
05.09.2022
What water quality do you use for cold WFI production?
zur Antwort
29.08.2022
What is the required evaluation period for the Product Quality Review?
zur Antwort
22.08.2022
Why must sterile filters not be used in water systems to retain germs?
zur Antwort
15.08.2022
What are the responsibilities of the Qualified Person according to EU Annex 16?
zur Antwort
08.08.2022
Who is responsible for the implementation of a Batch Record Review?
zur Antwort
01.08.2022
What are the disadvantages of using activated charcoal filters in water treatment?
zur Antwort
25.07.2022
What are the main tasks of the Head of Quality Control?
zur Antwort
18.07.2022
What parameters are hidden behind "Feedwater Conductivity Equivalent", and what are they needed for?
zur Antwort
04.07.2022
Is it reasonable to test purified water for the presence of E. coli?
zur Antwort
27.06.2022
Where do SOPs need to be available?
zur Antwort
13.06.2022
Which spray heads can be used in CIP systems?
zur Antwort
06.06.2022
What four phases should the development of a cleaning process ideally go through?
zur Antwort
30.05.2022
What types of CIP systems are used in practice?
zur Antwort
23.05.2022
What formal aspects help to improve the readability of SOPs?
zur Antwort
16.05.2022
Which parameters determine the result of cleaning according to Sinner's circle?
zur Antwort
09.05.2022
What has to be considered in risk management?
zur Antwort
18.04.2022
Which categories of documents do the EU GMP Guidelines identify?
zur Antwort
11.04.2022
What are the 6 different types of Excel applications?
zur Antwort
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?
zur Antwort
21.03.2022
What is the function of metadata for document management?
zur Antwort
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