08.05.2023
What are the phases that characterise the life cycle of a computerised system?
zur Antwort
01.05.2023
What is the purpose of a responsibility matrix?
zur Antwort
24.04.2023
What is the qualification of a computerised system?
zur Antwort
17.04.2023
How can conformance with GMP requirements for active substances be proven?
zur Antwort
10.04.2023
What is the difference between strategic and tactical outsourcing?
zur Antwort
03.04.2023
What is the verification of a computerised system?
zur Antwort
27.03.2023
What are immunological medicinal products?
zur Antwort
20.03.2023
What is the validation of a computerised system?
zur Antwort
12.03.2023
What contracts are usually concluded in outsourcing?
zur Antwort
06.03.2023
What are the elements of a computerised system?
zur Antwort
27.02.2023
Which active ingredient manufacturers receive an EU GMP certificate?
zur Antwort
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
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
14.11.2022
Why does the performance qualification of a water supply system take one year?
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
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?
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