GMP NEWS 2020

The European Commission has published Version 17 of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use".

In the context of process validation, the FDA attaches considerable importance to a "state of control". The FDA expects evidence of this "state of control" as part of stage 3 "continued process verification" within the validation lifecycle. Now, what exactly does the FDA want to see? Parts of the answer to this question can be found in Warning Letters.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Danish drugmaker for serious GMP violations, including inadequate testing of finished products. Furthermore, the company failed to conduct at least one test to verify the identity of each component of a drug product.

A US-American pharmaceutical manufacturer of OTC solutions and suppositories has received a Warning Letter from the US-American FDA due to non-executed repairs and deficiencies in cleaning and laboratory testing.

Due to the current Sars-CoV-2 outbreak, more and more people started working from home; this includes Qualified Persons (QPs). But what do the regulators say when it comes to batch certification?

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 7: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?

Because of the Corona crisis, the fact that an auditor has to visit a site currently presents a potential risk to all persons involved or might simply not be possible because of travel bans. What are the options now?

By providing information on the safety of cell and tissue products in relation to coronavirus, the FDA gives support in questions of transferability by donors.

The FDA has revised its assessments and recommendations to reduce the possible risk of transmission of Creuzfeldt-Jakob by blood and blood products.