24.03.2025

What options are there for evaluating the Quality System?

zur Antwort
17.03.2025

What does quality oversight mean?

zur Antwort
10.03.2025

How are responsibilities split between Quality Control and Quality Assurance?

zur Antwort
03.03.2025

Who is responsible for establishing the Pharmaceutical Quality System and making it work?

zur Antwort
24.02.2025

What means Limit of Quantitation (LOQ)?

zur Antwort
17.02.2025

What is a Certificate of Analysis (COA)?

zur Antwort
10.02.2025

What is a Biosafety Level (BSL)?

zur Antwort
03.02.2025

What does Annual (Product) Review mean?

zur Antwort
27.01.2025

What are endotoxins and what are their effects?

zur Antwort
20.01.2025

What requirements for "Good Distribution Practice" can be found in national and international regulations?

zur Antwort
13.01.2025

How is pure steam produced and used?

zur Antwort
06.01.2025

What are the different types of pharmaceutical water?

zur Antwort
30.12.2024

What special features need to be considered when determining the total microbial count in pharmaceutical water?

zur Antwort
23.12.2024

Where can I find specific information on the subject of "transport and temperature"?

zur Antwort
16.12.2024

What information must be included in the microbiological monitoring plan?

zur Antwort
09.12.2024

How is a physicochemical monitoring program structured?

zur Antwort
02.12.2024

Which filters are used in safety cabinets, and which filter tests are to be carried out?

zur Antwort
25.11.2024

What special factors need to be considered for sterile filtration?

zur Antwort
18.11.2024

What needs to be considered when validating a sterility test method?

zur Antwort
11.11.2024

What are isolators and what are they used for in the pharmaceutical industry?

zur Antwort
04.11.2024

What is the EDQM and what are its tasks?

zur Antwort
28.10.2024

What is the EMA and what tasks does it fulfil?

zur Antwort
21.10.2024

Which parameters are relevant in the monitoring of pharmaceutical water?

zur Antwort
14.10.2024

What types of cabinets are available?

zur Antwort
07.10.2024

What needs to be taken into account when using and maintaining safety cabinets?

zur Antwort
30.09.2024

Where can you find regulatory requirements for isolator technology?

zur Antwort
23.09.2024

What needs to be considered when validating a sterility test method?

zur Antwort
16.09.2024

What special factors need to be considered for sterile filtration?

zur Antwort
09.09.2024

What requirements are placed on cleanroom personnel?

zur Antwort
02.09.2024

What is the Sterility Assurance Level (SAL)?

zur Antwort
26.08.2024

How can a sterilisation process be checked?

zur Antwort
19.08.2024

Which sterilisation methods are used in the manufacture of sterile products?

zur Antwort
12.08.2024

What are the legal requirements for plastics?

zur Antwort
05.08.2024

What should be considered when selecting a suitable sealing material?

zur Antwort
29.07.2024

Which lubricants can be used in a GMP environment?

zur Antwort
22.07.2024

Which different types of stainless steel are available?

zur Antwort
15.07.2024

What general hygiene measures need to be observed in storage areas?

zur Antwort
08.07.2024

Which phases characterise the life cycle of a computerised system?

zur Antwort
01.07.2024

Why does it take a year to qualify the performance of a water supply system?

zur Antwort
24.06.2024

What does reprocessing mean in the production of APIs?

zur Antwort
17.06.2024

What does the catchphrase "Supply Chain Integrity" mean?

zur Antwort
10.06.2024

What is DIN Spec. 91323?

zur Antwort
03.06.2024

What is the advantage of Building Information Modeling (BIM) for planning new premises?

zur Antwort
27.05.2024

What is adjustment?

zur Antwort
20.05.2024

What must be observed when planning and designing distribution systems for pure steam?

zur Antwort
13.05.2024

What quality requirements must pure steam meet?

zur Antwort
06.05.2024

What are the basic physical principles of steam generation?

zur Antwort
29.04.2024

What do the authorities expect during the first inspections after the revised Annex 1 came into force?

zur Antwort
22.04.2024

What is the focus for personnel in the revised Annex 1?

zur Antwort
15.04.2024

What was the reason for the revision of Annex 1?

zur Antwort