20.02.2023

Under what conditions may a contract acceptor subcontract activities to third parties?

zur Antwort
13.02.2023

Which product groups are included under the term immunological medicinal products?

zur Antwort
06.02.2023

In outsourcing, who is responsible for the quality of the medicinal products produced?

zur Antwort
30.01.2023

What are the objectives of personnel medical examinations?

zur Antwort
23.01.2023

What is the dual function of protective clothing in pharmaceutical manufacturing?

zur Antwort
16.01.2023

What do inspectors of premises and rooms pay particular attention to?

zur Antwort
09.01.2023

How can the suitability of premises be verified?

zur Antwort
02.01.2023

To which products does the new Annex 21 to the EU GMP Guide apply?

zur Antwort
19.12.2022

What is meant by import?

zur Antwort
12.12.2022

What are the 3 main types of safety features against drug counterfeiting?

zur Antwort
05.12.2022

What are the advantages of a dynamic e-form?

zur Antwort
28.11.2022

At what point may water be used during the performance qualification of a water supply system?

zur Antwort
21.11.2022

What is a static form?

zur Antwort
14.11.2022

Why does the performance qualification of a water supply system take one year?

zur Antwort
07.11.2022

What is a generic form?

zur Antwort
31.10.2022

What are the advantages of integrated qualification?

zur Antwort
24.10.2022

What differences are there between electronic document management systems (eDMS) and electronic quality management systems (eQMS)?

zur Antwort
17.10.2022

Which phases are distinguished in the performance qualification of a water supply system?

zur Antwort
10.10.2022

What are the main tasks of the Head of Production?

zur Antwort
03.10.2022

What are the advantages and disadvantages of in-line measurement of the conductivity of water for injection (WFI)?

zur Antwort
26.09.2022

What are endotoxins?

zur Antwort
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?

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