Pharma GMP News of the Week: 14-November-2021

Period: November 07, 2021 to November 13, 2021

US FDA Update: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability

Details as per content updated on FDA site upto November 08, 2021

U.S. FDA provided information on FDA website regarding upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances.  The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).

Source: https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-complex-generic-drug-product-development

Federal Register: https://public-inspection.federalregister.gov/2021-24431.pdf?utm_source=federalregister.gov

Pharmacopoeial Discussion Group (PDG) signs-off on milestone harmonised general chapter on chromatography

Date of news: November 08, 2021

As per the EDQM, “The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for this text was the Ph. Eur.”

The scope of this harmonization is applicable for TLC, HPLC, and GC.

For more information, read the following press release.

Press release: https://www.edqm.eu/sites/default/files/press-release-pheur-pdg-revised-chapter-chromatography-november-2021.pdf

Concept Papers on the revision of EU-PIC/S GMP Annexes 4 & 5

Date of news: November 10, 2021

As per the news by PICS, “the PIC/S Working Group on Veterinary Medicinal Products (VMP), led by Grégory Verdier (France / ANSES), and the EMA GMP/GDP Inspectors Working Group have jointly developed two concept papers on the revision of Annex 4 (manufacture of veterinary medicinal products other than immunologicals) and Annex 5 (manufacture of immunological veterinary medicinal products) of the EU-PIC/S GMP Guide”.

Download: Concept paper on the revision of annex 4 of the guidelines on good manufacturing practice – manufacture of veterinary medicinal products other than immunologicals

Download: Concept paper on the revision of annex 5 of the guidelines on good manufacturing practice for medicinal products – manufacture of immunological veterinary medicinal products

Scroll to Top