TOP 15 Countdown: “Question of the Week”

Every week we publish GMP related questions which you might have asked yourself before. Get short and precise answers, links and working material to the corresponding chapters in the GMP Compliance Adviser.

(The question and the appropriate answer will be available online for one week – until the next quiz question comes up).

Now you have the opportunity in our Lead article to view the most clicked questions in 2019. Could you answer them yourself? If not, you are not alone. Just follow the link and get the answer from the GMP Compliance Adviser for more in-depth knowledge.

Happy reading!

15.
Who is responsible for planning and implementing cleaning validation?

The Head of Production and Head of QC are jointly responsible for planning and implementing the cleaning validation because production-related processes (cleaning of equipment) and testing processes (sampling and residue analysis) are affected by the cleaning validation.

> Read more in the GMP Compliance Adviser: Chapter 8.A

14.
When is it imperative to monitor transport temperatures for finished drug products?

Monitoring is important especially in the initial phases of cooperation with a logistic service provider and during validation processes.

> Read more in the GMP Compliance Adviser: Chapter 16.J.1

13.
What is the difference between an EDMS and an EQMS?

While an EDMS (electronic document management system) focuses on the document, an EQMS (electronic quality management system) is mainly focused on the management of processes such as change and deviation management or CAPA. An EDMS is in effect a part and prerequisite of the EQMS.

> Read more in the GMP Compliance Adviser: Chapter 1.H

12.
Which countries are covered by the British Pharmacopoeia?

The British Pharmacopoeia also applies to Australia, Canada and around 100 other countries on almost all continents.

> Read more in the GMP Compliance Adviser: Chapter 14.K.5

11.
Do USP methods need to be validated by the user?

The methods in the USP are validated for the use foreseen in the USP (21 CFR 211.194(a)(2)).The method sought by the USP here is described in chapter <1225> Validation of Compendial Procedures. In this respect, the method in the USP corresponds to that in the European Pharmacopoeia. When working with the USP, however, it is essential for users to perform a verification before carrying out an analytical test. The procedure for this is described in chapter <1226> Verification of Compendial Procedures. This is also required in the FDA validation guideline.

> Read more in the GMP Compliance Adviser: Chapter 14.K.6

10.
Do European Pharmacopoeia methods need to be validated by the user?

The test methods and procedures specified in the substance monographs are validated as part of the elaboration of the monographs. The methods of the Ph. Eur. are therefore accepted as validated by the European regulatory authorities, so that a reference to the relevant monograph is sufficient. Additional validation by the user is only necessary if this is expressly required in the text.

> Read more in the GMP Compliance Adviser: Chapter 14.K.4

9.
Who is responsible for generating the PQ protocols?

In most cases equipment from different suppliers are linked together and subject to PQ as a complete plant or line. As a consequence, the documentation required for the PQ must be generated by the pharmaceutical manufacturer.

> Read more in the GMP Compliance Adviser: Chapter 6.G

8.
Why is a system suitability test (SST) performed in addition to equipment qualification?

Clear and correct analytical results can only be achieved if the quality and performance of the analytical instruments are guaranteed to remain constant. This is essential for the assessment of the quality of the product to be tested. If system suitability tests are available, the risk analysis required in the event of equipment failures can be limited to the period back to the last successful system suitability test and does not have to cover the entire period back to the last successful qualification.

> Read more in the GMP Compliance Adviser: Chapter 14.C.15

7.
What is meant by the term "metadata"?

Metadata is data that describes the attributes of other data, e.g. their structure, data elements, inter-relationships and other characteristics. They also allow attribution of data to individuals or data sources (following MHRA GxP Data Integrity Definitions and Guidance for Industry, Draft 2016).

> Read more in the GMP Compliance Adviser: Chapter 15.H.3

6.
What is the significance of growth controls in microbiological monitoring?

Growth controls support the evaluation of culture media without evidence of growth that were used during hygiene monitoring. They rule out the likelihood of incorrect negative results. Growth controls check the functionality of the culture medium used and the disinfectant neutraliser it contains.

> Read more in the GMP Compliance Adviser: Chapter 10.E

5.
Why should inactivating agents be added to the culture media when performing tests for microbiological monitoring?

Inactivating agents should be added to the medium to anticipate the presence of absorbed growth-retarding substances and inactivate them.

> Read more in the GMP Compliance Adviser: Chapter 10.E

4.
Is it necessary to wear gloves in cleanroom class D?

Gloves must only be worn when working with open product.

> Read more in the GMP Compliance Adviser: Chapter 11.B.1.1

3.
What are the major trends that have changed the concept of validation recently?

Validation is understood as a lifecycle model instead of an isolated action. Continuous data evaluation replaces gathering and archiving data as evidence. Risk-based action replaces extensive action for maximum compliance.

> Read more in the GMP Compliance Adviser: Chapter 7.B.2.1

2.
What is the difference between the point of occurrence and the point of recognition of a failure?

The point of occurrence (PoO) is the point at which a failure situation actually occurs for the first time, whereas the point of recognition (PoR) is the point at which the failure situation is recognised. PoO and PoR can (but don't have to be) identical.

> Read more in the GMP Compliance Adviser: Chapter 20.E

1.
What is the minimum requirement for cleaned equipment?

An essential requirement is that every machine is visually clean after cleaning. The visually clean criterion therefore is always the minimum requirement.

> Read more in the GMP Compliance Adviser: Chapter 8.A

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