24.10.2017 |

LOGFILE No. 47/2017 – Ask Our Experts – Part 1 – 6 GMP-Questions which might be of interest to You

Ask Our Experts – Part 1

6 GMP-Questions which might be of interest to you

7 minutes reading time

by Sabine Rabus

Being aware of all current aspects of GMP is quite a tough job. To clarify pending issues is an almost everyday business. The subscribers of our GMP Compliance Adviser, the world’s most comprehensive GMP online knowledge, have the unique opportunity to get answers to those GMP-questions that cannot be resolved within their company or that need additional expert advice. Since the introduction of the Ask Our Experts-Button time has shown that our service is not only well received but also extensively used by our customers.

For our LOGFILE readers we have compiled ten questions that reached us through the Ask Our Experts-Button. Today you’ll read the first six question and answers. We believe they will be of interest to other GMP-professionals as well. Check them out!

1. What is the difference between Quality Plan and Quality Manual?

Quality Plan

This is more coming from the Medical Device industry and is meanwhile sometimes used

to fulfill senior management requirements in the sense of taking responsibility. See also the links below. There are no formal requirements, nor the legal need to have such a document.

Quality Manual

This is usually the collection of quality procedures in a company. For example all the quality related SOPS, policies together in one file or hardcopy – our quality manual or you could also say our quality document collection.

Relevant chapters in the GMP Compliance Adviser:

Chapter 1.D.1.3: Quality Planning

Chapter 23.B.3: Quality Planning (Medical Devices)


2. How is old equipment, especially an old machine, to qualify?

Generally said, an “old machine” has to be qualified the same way a “new machine” has to. The purpose is always to provide evidence that the equipment is fit for the intended purpose throughout its lifecycle. As a piece of equipment ages, the probability of failure tends to increase. This may require further re-qualification steps (risk analysis, more periodic reviews) and coming with this a more detailed documentation.

Chapter 6 Qualification of the GMP Compliance Adviser offers plenty of information regarding that matter. Especially the Chapters 6.A, 6.H and 6. J. can be recommended for reading.

Relevant chapters in the GMP Compliance Adviser:

Chapter 6: Qualification


3. Is it ok to mix two different sources of an active ingredient for one batch of product? For Example from India and Italy. Is this according to GMP?

Yes, you can blend compliant API batches.

You can find details in the following documents:

  • ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - Questions and Answers, Section 8.2
  • EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials, Section 8.4 Blending Batches of Intermediates or APIs.

Relevant chapters in the GMP Compliance Adviser:

Chapter E.7.1: ICH Q7 Guideline

Chapter C.5: EU GMP Guide Part II


4. What does “local transportation” mean in connection with the WHO guideline on good storage practices?

Local transportation is considered to be a “short-term interruption” when it comes to storing a drug product, meaning a transport over a short distance within a certain “regional” area, so rather in the same city and close surroundings.

Check out Chapter 24 of the GMP Compliance Adviser. Section 24.F.3 discusses the WHO guidelines in detail.

Relevant chapters in the GMP Compliance Adviser:

Chapter H.13: WHO Guide to good storage practices for pharmaceuticals

Chapter 24: Transportation


5. Which organisms need to be checked in disinfection validation (efficacy testing of cleaning agents used for cleaning of the Clean Rooms)?

According to current European standards the following test strains are obligatory:

  • Bactericidal efficacy
    S. aureus (ATCC 6538), P. aeruginosa (ATCC 15442), Ec. hirae (ATCC 10541), E. coli (ATCC 10536)
  • Fungicidal efficacy
    C. albicans (ATCC 10231), A. brasiliensis (ATCC 16404)
  • Sporicidal efficacy
    B. subtilis (ATCC 6633)

To perform the test more practical I would recommend to use in-house strains on company-specific test surfaces.

At least one gram+, one gram-, one yeast, one mould and one bacterial spore. If necessary you should complement with ATCC strains.

Relevant chapters in the GMP Compliance Adviser:

14.K Microbiological testing


6. Is it correct that for equipment, whose performance is defined by only one parameter (for example – centrifuge (not refrigerated one), the only performance parameter is RPM), validation/re-validation is not required?

The requirements of Annex 15 of the EU GMP Guidelines can be summarized as follows:

  • Equipment qualification is required in general, no matter how many functions are to be tested.
  • The qualified status has to be upheld, e.g. by means of maintenance, and monitored by means of change control.
  • Revalidation is required in risk-based intervals.

On the other hand, the Guidelines allow to define the scope and depth of validation/qualification based on a risk analysis.

So it is possible to make a “small” qualification for simple equipment, and to define the time interval and the relevant tests for requalification by your own.

For detailed information on this topic, you should have a look at chapter 6.J of your GMP Compliance Adviser, especially the section on classification of equipment in risk categories.

This sample-SOP should answer all your questions around equipment qualification.

Relevant chapters in the GMP Compliance Adviser:

Chapter 6.J: Example SOP for the qualification of equipment and machinery

Chapter C.6.15: EU GMP Guide Annex 15



In part 2 of the article you'll read questions and answers on labelling of incoming materials containers, operating ranges for air change per hour, expiry date of HEPA filters, and in-house calibration by an unauthorized laboratory.


Sabine Rabus
Maas & Peither AG – GMP Publishing
Schopfheim, Germany
E-Mail: sabine.rabus@gmp-publishing.com