15.07.2019
What is the Design Qualification?
zur Antwort
08.07.2019
Why is a system suitability test (SST) performed in addition to equipment qualification?
zur Antwort
01.07.2019
When is it imperative to monitor transport temperatures for finished drug products?
zur Antwort
24.06.2019
Which criteria are to be considered when selecting cleaning agents?
zur Antwort
10.06.2019
Why should OQ tests cover the entire working range of the equipment?
zur Antwort
03.06.2019
Who is responsible for generating the PQ protocols?
zur Antwort
27.05.2019
Which are the key aspects of personnel hygiene?
zur Antwort
20.05.2019
What is the difference between an EDMS and an EQMS?
zur Antwort
13.05.2019
What are the so-called safety features on packaging materials?
zur Antwort
06.05.2019
What is the advantage of a 2D-MatrixCode?
zur Antwort
29.04.2019
How can a uniform colouring of secondary packaging materials be achieved?
zur Antwort
15.04.2019
What are print data for secondary packaging materials?
zur Antwort
08.04.2019
What is the disadvantage of a sit-over bench?
zur Antwort
01.04.2019
Is it acceptable to use a transport trolley for material transfer from one cleanliness class to another?
zur Antwort
25.03.2019
Which materials can be used for furniture and furnishings in cleanliness Grade C?
zur Antwort
18.03.2019
What are the major trends that have changed the concept of validation recently?
zur Antwort
11.03.2019
What should be considered when installing automatic sliding doors in cleanrooms?
zur Antwort
04.03.2019
What is the advantage of Building Information Modeling (BIM) for planning new premises?
zur Antwort
25.02.2019
Which role plays a runner during an inspection?
zur Antwort
18.02.2019
What is the difference between a bubble type and a sink type pressure cascade?
zur Antwort
11.02.2019
Which general requirement applies to the design of material locks?
zur Antwort
04.02.2019
What is meant by the term "metadata"?
zur Antwort
28.01.2019
Is it necessary to wear gloves in cleanroom class D?
zur Antwort
21.01.2019
What is the significance of growth controls in microbiological monitoring?
zur Antwort
14.01.2019
What is the minimum requirement for cleaned equipment?
zur Antwort
07.01.2019
Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?
zur Antwort
24.12.2018
What is the significance of an action level?
zur Antwort
17.12.2018
Should calibration be done during IQ or as part of OQ?
zur Antwort
10.12.2018
What is the significance of an alert level?
zur Antwort
03.12.2018
Welche Voraussetzungen müssen bei der Vergabe von Prüfungen an ein Lohnlabor zwingend erfüllt sein?
zur Antwort
26.11.2018
Welche Anforderung wird an ein Auftragslabor gestellt, das neben der Prüfung auch eine Freigabe durchführt?
zur Antwort
19.11.2018
Was versteht man unter Device Master Record (DMR) und Device History Record (DHR)?
zur Antwort
05.11.2018
Welche Bedeutung haben Ionenaustauscher bei der Pharmawasseraufbereitung?
zur Antwort
29.10.2018
Für welche Zwecke werden UV-Strahler in Wasseraufbereitungsanlagen eingesetzt?
zur Antwort
22.10.2018
Was ist Ultrafiltration und wofür wird sie eingesetzt?
zur Antwort
10.09.2018
Wie ist die Instandhaltungsrate definiert?
zur Antwort
03.09.2018
Welche Maßnahmen beinhaltet die Instandhaltung?
zur Antwort
27.08.2018
Welche Aufgabe erfüllt die Instandhaltung?
zur Antwort