News

The current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). In December 2023, Appendix 1 was updated and now contains five additional substances.

More

In a recent Warning Letter from the US FDA, the authority refutes a medicinal product manufacturer's argument that a failure rate of 0.011% does not trigger further action. How does the FDA argue here?

More

The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.

More

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

More

China has passed a revised counter-espionage law that extends the powers to combat espionage. This increases the legal uncertainty for GMP inspections and audits.

More

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

More

Two pharmaceutical companies had received a Warning Letter from FDA without ever having been inspected on site. This was purely on the basis of a remote evaluation.

More

The U.S. Food and Drug Administration (FDA) has sent a Warning Letter to a manufacturer of over-the-counter (OTC) drug products. Based on a review of record, the authority found several CGMP violations. These concern inadequate identity testing of incoming components and finished drug products. Furthermore, an adequate stability testing program was not implemented.

More

A recently published 483 for a sterile manufacturer shows once again that the issue of supplier control is an ongoing concern for the US FDA. However, this is not the only focus in this report, as there are 13 other, sometimes detailed (and hair-raising) observations over 20 pages.

More

More than two years ago, the FDA published a Guidance for Industry on remote evaluations: "Remote Interactive Evaluations". Now the successor has been published as a draft. Not much has changed, except for one important innovation.

More
x
Search