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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!
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.
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.
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.
Yes, you can blend compliant API batches.
You can find details in the following documents:
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.
According to current European standards the following test strains are obligatory:
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.
The requirements of Annex 15 of the EU GMP Guidelines can be summarized as follows:
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.
Maas & Peither AG – GMP Publishing