29.07.2019

What is the objective of laboratory equipment qualification?

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22.07.2019

What is adjustment?

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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?

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24.06.2019

Which criteria are to be considered when selecting cleaning agents?

zur Antwort
17.06.2019

How should raw data be handled?

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?

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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?

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29.04.2019

How can a uniform colouring of secondary packaging materials be achieved?

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22.04.2019

What is meant by serialisation?

zur Antwort
15.04.2019

What are print data for secondary packaging materials?

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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?

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25.03.2019

Which materials can be used for furniture and furnishings in cleanliness Grade C?

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18.03.2019

What are the major trends that have changed the concept of validation recently?

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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?

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18.02.2019

What is the difference between a bubble type and a sink type pressure cascade?

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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
31.12.2018

What is a training profile?

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?

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