GMP News - Quality Assurance

A letter from the UK government to medicines and medical products suppliers extends the transitional phase for the recognition of EU batch tests beyond 2022.

EMA´s Committee on Herbal Medicinal Products published the 2021 HMPC Work plan. Amongst others the HMPC plans to establish a Cannabis glossary and to revise the GACP guidelines.

The German Federal Institute for Risk Assessment has issued a new statement recommending that the assessment of hemp-based food products be based on the EFSA-derived acute reference dose of 1 microgram Δ9-THC/kg body weight.

The EMA has updated its Q&A document on the implementation of the Protocol on Ireland and Northern Ireland and clarified the recognition of inspections.

In the FDA Guidance for Industry on process validation, there is also a short section on concurrent validation. Concurrent validation should be used rarely, but may be possible if, for example, products are manufactured infrequently or medically necessary products are needed for short-term market supply. A recent Warning Letter underlines the guideline's statement that concurrent validation should be used rarely.

The USP General Chapters - Physical Analysis Expert Committee revised the general chapter <1912> Measurement of Hardness of Semisolids. Amongst others, a definition for "yield stress" has been added.

Although the FDA currently conducts virtually no inspections, Warning Letters continue to be issued; in January, for example, to a pharmaceutical manufacturer in Florida.