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
06.09.2021

What is a third-party audit?

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
16.08.2021

What is a shared 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
26.07.2021

How are deviations defined?

zur Antwort
19.07.2021

What is pharmacovigilance?

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
21.06.2021

What significance do OEBs have?

zur Antwort
14.06.2021

What task do code readers have on a packaging line?

zur Antwort
07.06.2021

What is an OEL value?

zur Antwort
31.05.2021

What does line clearance mean?

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
25.01.2021

What is an excipient?

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
04.01.2021

How does ultrafiltration work?

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
26.10.2020

What is an informal QRM method?

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