Annex 1 sterile medicinal product manufacture conference approaches

Cherwell Laboratories, specialist supplier of products for environmental monitoring and process validation, will be exhibiting and participating in a key EU GMP Annex 1 Draft Revision Insight meeting at Leamington Spa on 12 March

To be jointly hosted by the PHSS (Pharmaceutical & Healthcare Society) and the PQG (Pharmaceutical Quality Group), the event aims to provide a forum for discussion with invited regulatory authorities (MHRA) on this highly significant sterile drug GMP guideline update close to the end of the consultation period.

The conference follows the recent publication of the revised draft of the EU Annex 1 Manufacture of Sterile Medicinal Products.

This long-awaited revision of sterile drug GMP guidelines is intended to address new issues like quality risk management, as well as new technologies and procedures in the cleanroom environment.

Aimed at developing globally agreed standards, the Annex 1 revision will impact both sterile medicinal product manufacturing and also other sectors, including advanced therapies and hospital pharmacy aseptic services.

As a leading supplier of technologies that support aseptic processing and the production of sterile therapeutics, Cherwell’s Microbiology Product Specialist, Andrew Ramage, has published a series of blogs relating to the update EU GMP Annex 1 update: The devil’s in the detail.

Ramage said: “The new version of Annex 1 is a far more detailed document aimed at addressing loss of knowledge in recent years caused by experienced staff in the sector retiring. This is reflected by the fact that the new document is 50 pages long, compared to the current version of just 16 pages. However, despite its length, the new version is arguably easier to navigate.”

Conference sessions will include a keynote presentation by Andrew Hopkins, MHRA and Annex 1 project leader, who will provide a regulatory perspective, followed by a pharmaceutical industry perspective to be given by Ian Symonds of GSK.

There will also be discussion on key concerns, including open questions from the conference audience with responses from the MHRA and pharmaceutical industry representatives.

Andrew Ramage will be attending all sessions of the joint PHSS and PQG conference and in his ongoing blog will report on the industry response and that of the regulators, to the comments made.

Cherwell will also be exhibiting its high-quality cleanroom microbiology products designed to meet the very specific requirements of environmental monitoring and process validation applications within the pharmaceutical and healthcare sciences industry.

The Cherwell range includes Redipor prepared media, stainless steel accessories and SAS microbial air samplers.


Learn more about Annex 1 — ISO 14644 — part 1 & 2 updates and final revisions at this year's Cleanroom Technology Conference

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