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
09.08.2021
What interfaces to other quality systems does the deviation management have?
zur Antwort
02.08.2021
What is the European safety referral used for?
zur Antwort
12.07.2021
What is RAN and what is its purpose?
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?
zur Antwort
12.04.2021
What are the steps of an inspection procedure?
zur Antwort
05.04.2021
In which countries do the GMP rules for active ingredients according to ICH Q7 apply?
zur Antwort
29.03.2021
What activities does the distribution of active ingredients involve?
zur Antwort
22.03.2021
What should you bear in mind when maintaining rooms?
zur Antwort
15.03.2021
What is important for the processing of deviations?
zur Antwort
08.03.2021
Which metrics should be looked at when reviewing the status of a site?
zur Antwort
01.03.2021
How are self-inspections documented?
zur Antwort
22.02.2021
What does a company that has incorporated a proactive compliance program look like?
zur Antwort
15.02.2021
What are the advantages of using Ultrafiltration?
zur Antwort
08.02.2021
How do you determine the frequency of self-inspections?
zur Antwort
01.02.2021
What is the difference between an EU regulation and an EU directive?
zur Antwort
18.01.2021
Who developed the fishbone diagram?
zur Antwort
11.01.2021
To which areas does the self-inspection refer?
zur Antwort
21.12.2020
What is an active pharmaceutical ingredient (API)?
zur Antwort
14.12.2020
What is the purpose of self-inspections?
zur Antwort
07.12.2020
How does electro-deionisation work?
zur Antwort
30.11.2020
What does reworking mean in the production of APIs?
zur Antwort
23.11.2020
What is a fishbone diagram used for?
zur Antwort
16.11.2020
How do you ensure the traceability of the batch documentation?
zur Antwort
09.11.2020
What does reprocessing mean in the production of APIs?
zur Antwort
02.11.2020
What are the pros and cons when using UV irradiation in water pre-treatment systems?
zur Antwort
19.10.2020
Which two factors are particularly important for a GMP-compliant process validation?
zur Antwort
12.10.2020
How does a risk assessment work?
zur Antwort
05.10.2020
How can UV irradiation be used in pharmaceutical water generation?
zur Antwort
