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
11.07.2022

What is a Batch Record Review?

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
20.06.2022

What is a verified copy?

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
02.05.2022

To whom are SOPs addressed?

zur Antwort
25.04.2022

What is a true copy?

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
21.02.2022

What is meant by archiving?

zur Antwort
14.02.2022

What is an ASMF?

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
10.01.2022

What is a stability commitment?

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
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 a GMP inspection?

zur Antwort
04.10.2021

What is IT governance?

zur Antwort