GMP News

In March, the U.S. FDA published the draft of the "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Exchange document" for comments.

The comment period for the draft revised ICH Q9 Guideline Q9 (Quality Risk Management) published in December ended in March. Now the feedback has been published.

The glossary summarizes existing scientific and legislative terminology relevant for medicinal products containing Cannabis-derived active substances. What is CBD oil and what is Cannabis oil?

Currently there are no compendial standards available for metal packaging systems for pharmaceutical use. Thus any other guidance providing information on metal components like the revised EDQM technical guide “Metals and alloys used in food contact materials and articles” can be useful.

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.

Following the previously published Ph. Eur drafts for COC / COP, a new Ph. Eur. chapter 3.1.18. Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations has been proposed in Pharmeuropa.

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a Californian firm that utilizes Contract Manufacturing Organizations (CMOs) to manufacture nasal spray products. The FDA criticises the lack of a quality unit (QU), an insufficient investigation into microbial contamination and an inadequate stability program.

A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document?

The 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities.

With a draft guidance for the development, manufacture and control of chimeric antigen receptor (CAR) T cell products, the FDA is expanding its recommendations for advanced biological products and providing further guidance to developers and manufacturers.

Gene therapies are becoming increasingly important. One method is the so-called genome editing. The FDA has published a draft guidance for Investigational New Drugs (IND) for these Gene therapy products.