EMEA Publishes New Q&A Document on Its Website

GMP News No. 846

GMP News
30 November 2006

EMEA Publishes New Q&A Document on Its Website

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:


If your daily work implies complex validation issues, we recommend you the 3-day GMP Education Course:

The Validation Manager to be held in Barcelona, Spain, from 31 January to 2 February 2007
Compiled by:
Wolfgang Heimes
On behalf of ECA

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