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
28.09.2020

What role does quality risk management play in the quality management system?

zur Antwort
21.09.2020

In which phases is the quality risk management process divided?

zur Antwort
14.09.2020

What are the requirements for successful quality risk management (QRM)?

zur Antwort
07.09.2020

What are complexing agents and how do they work?

zur Antwort
31.08.2020

What are the advantages and benefits of quality risk management (QRM)?

zur Antwort
24.08.2020

What is a residual risk?

zur Antwort
17.08.2020

What has to be considered for risk management?

zur Antwort
10.08.2020

Why is the use of activated carbon filters critical as a pre-treatment process?

zur Antwort
03.08.2020

What is a risk?

zur Antwort
27.07.2020

What is hygienic design?

zur Antwort
20.07.2020

What is an action limit, and what happens when it is exceeded?

zur Antwort
13.07.2020

Why has drinking water to be pretreated when using it for pharmaceutical water production?

zur Antwort
06.07.2020

What is commissioning?

zur Antwort
29.06.2020

What is monitoring?

zur Antwort
22.06.2020

What is metrology?

zur Antwort
15.06.2020

What phases are involved in planning a construction project?

zur Antwort
08.06.2020

What does official calibration mean?

zur Antwort
01.06.2020

What is an alert limit, and what happens when it is exceeded?

zur Antwort
25.05.2020

What is meant by adjustment?

zur Antwort
18.05.2020

What types of requalification are distinguished?

zur Antwort
11.05.2020

What does calibration mean?

zur Antwort
04.05.2020

What is confirmed by an ATP certificate?

zur Antwort
27.04.2020

What is meant by measurement chain?

zur Antwort
20.04.2020

What data is monitored when monitoring a HVAC system?

zur Antwort
13.04.2020

Which criteria shoud be used for the selection of insulated transport boxes?

zur Antwort
06.04.2020

What is the purpose of a measurement point risk analysis?

zur Antwort
30.03.2020

What is meant by cleanroom equipment?

zur Antwort
23.03.2020

Which key aspects should be addressed when defining the requirements profile of a logistics service provider?

zur Antwort
16.03.2020

Which test is used to determine the conductivity of pharmaceutical water qualities?

zur Antwort
09.03.2020

How are medicinal products requiring cool transport conditions labeled for air freight?

zur Antwort
02.03.2020

For what purposes can drinking water be used in the pharmaceutical industry?

zur Antwort
24.02.2020

What guidelines and quality standards apply to airfreight?

zur Antwort
17.02.2020

Where is a qualification according to DIN Spec. 91323 applicable?

zur Antwort