GMP:Blog

Should there be a microbiological monitoring program in place specifically for the drains?

First of all, drains in production rooms are not permitted in class A/B (EU GMP Guide, Annex 1 No. 50) which means the question should refer exclusively to production rooms starting with class C. Further information on the construction of drains can  be found in EU GMP Guide Part I, 3.11.

A manufacturer of pharmaceutical production facilities and containers must provide evidence of FDA conformity of materials in contact with the product, especially sealing materials. This repeatedly leads to discussions within the company about the validity period of corresponding supplier certificates. Is a certificate simply valid until a new certificate is issued because, for example, the material composition has changed? Is a 10-year-old certificate of conformity still valid?

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.

In today`s feature, we answer a question on the need for monitoring in “unclean airlock areas” for non-sterile production. Read about the intriguing and heterogenous answers of our experts.

This time we answer questions on the triggering of OOS investigations with information from the GMP Compliance Adviser and further statements by a GMP inspector and a quality unit manager. As a LOGFILE subscriber, you too will be kept up to date and at the same time gain an insight into the diverse activities of our editorial team.

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.

In today`s feature, we answer a question on the practical implementation of the sampling of medicinal products and active substances. Who can do that? Sampling affects all areas of pharmaceutical production and is an important basis for quality decisions.