The Quality Working Party (QWP) of the European Medicines Agency (EMEA)
has published a current catalogue of questions and answers on
inspections on the Agency's website.Among
them are quite interesting questions, like e.g. which regulatory
consequences exist in the implementation of an alternative
microbiological rapid method for determining the quality of water for
injection and purified water.
In its answer, the EMEA says that, according to the current
legislation in the EU, manufacturers of medicinal products have to use
water in compliance with the standard defined in the European
Pharmacopoeia (Ph.Eur.). Recently, a new chapter dealing with the
acceptance of "Rapid Microbiological Methods" as a substitute for
traditional methods was included into the Ph.Eur. The prerequisite for
acceptance is appropriate validation.
The QWP as well as the ad hoc GMP inspectors' group both suggest that
these methods should be carefully reviewed in order to ensure that the
validation and the water used fulfil the Ph.Eur. requirements. However,
since there is no product-specific validation for water, a company can
ask the supervisory authority for a specific site inspection - if
necessary involving a pharmaceutical assessor.
On the whole, the authority expects that the water meets the
specifications defined in the Ph.Eur. Therefore, in case of a test, no
change to dossier requirements would be necessary and normally, no
regulatory consequences for individual products would be anticipated.
Another question deals with the validation of the manufacturing
process in case a bulk product is used to manufacture a series of
products - which are the criteria for defining the pilot batch size?
The authority says that this decision is up to the applicant. In its
answer, the QWP also refers to the guideline on process validation
(CPMP/QWP/848/96, CVMP/598/99) that was drawn up jointly by CHMP and
CVMP. Where it is justified, this guideline leaves a certain scope to
the applicants. They only have to prove that the batch size defined for
validation is big enough to provide reliable information on the complete
production.
Besides, in its answer to another question, the Agency confirms that
reduced test designs are possible in stability studies on medicinal
products for veterinary use. However, the chosen design must be
sufficiently explained and justified. Even though the ICH
Guideline Q1D "Bracketing and Matrixing Designs for Stability Testing of
Drug Substances and Drug Products (CPMP/ICH/4104/00)" refers to new
drug substances and drug products for human use, manufacturers of
veterinary medicinal products can follow this guideline. In this case,
however, they should observe all aspects of the guideline.
The complete EMEA Q&A page can be found at this Internet address:
http://www.emea.eu.int/Inspections/QWPfaq.html
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