Ask our Experts
Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?
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.
Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?
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.
Late, but not too late? How to best define the final time point of a stability study?
"What is the best procedure for selecting samples from a stability chamber in the final test interval of ongoing stability tests? Could you please give me more detailed information on this? I know that it is the responsibility of companies to define a tolerance for taking samples fro...
Validity period of FDA Certificates of Conformity?
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?
When and how must OOS examinations be triggered?
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.
Who may carry out the sampling?
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.