GMP: Two new questions and answers have been added to the list of frequently asked GMP related questions. One question refers to the sampling requirements in order to carry out a sterility test when a finished batch is made up of more than one steriliser load. The other question refers to whether the sample size for retention purposes should be sufficient to enable the carrying out of a test for sterility on two separate occasions.
GMP and QWP: Since the introduction of a new obligation, in October 2005, for manufacturing authorisation holders to use active substances that have been manufactured in accordance with Good Manufacturing Practice (GMP), applicants for marketing authorisations, or relevant variations, have been required by the Notice to Applicants (Eudralex Volumes 2 and 6) to submit a declaration to this effect in the relevant submission.
The industry has reported difficulty in providing the required declarations for some active substances. The cases in question involve active substances whose primary industrial use is not as a pharmaceutical active substance (the term “Atypical Active” has been used to describe these substances) and the producers of these substances may not be aiming to meet the specific GMP requirements of their pharmaceutical customers, particularly where those customers represent an insignificant volume of business.
A Question and Answer has been prepared on this topic, which can be found on the Q&A pages for both the Quality Working Party and GMP.
Source: EMEA Inspections
On behalf of the European Compliance Academy (ECA)