Pharma GMP News of the Week: 6-March-2022

Period: February 27, 2022 to March 5, 2022

WHO published working document “1.14.1 CHROMATOGRAPHY 3 Draft proposal” for inclusion of it in the International Pharmacopoeia, Working document QAS/21.905

Month of news: February 2022

The draft proposal by WHO covers text regarding TLC, HPLC and GC. The initial draft document was prepared by referring and internationally harmonized (by the Pharmacopoeial Discussion Group).

The document covers following topics:

• Definitions of Distribution constant, Peak-to-valley ratio, Dwell volume, Plate number, Plate height, Relative retardation, Separation factor, Resolution, Symmetry factor, Signal-to-noise ratio and, System repeatability

• System suitability

• Quantitation

• Detector response

• Interfering peaks

• Measurement of peaks

• Reporting threshold

Source: https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/qas21_905_chromatography.pdf?sfvrsn=ca50e451_3

FDA released final guidance on “Pre-Launch Activities Importation Requests (PLAIR)”

Date of news: March 01, 2022

The objective of this guidance is to describe the FDA’s policy about importation requests of unapproved drug products by applicants of NDA, and ANDA who is preparing for product launch in U.S. market based on anticipated approval.

The guideline is also applicable for biologics licensing applications (BLAs) for which NDA, BLA, or ANDA approval is anticipated.

Source: https://www.fda.gov/media/86243/download

FDA released final guidance on “Pre-Launch Activities Importation Requests (PLAIR)”

Date of news: March 01, 2022

As per the guidance, this master protocol is designed with multiple sub-studies. This guidance recommendation is applicable for drugs or biologics for the treatment of cancer.

 The guidance recommends designing a master protocol to conduct clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure for adult and pediatric cancers.

Source: https://www.fda.gov/media/120721/download

As per EMA website, “Regulation on EMA’s extended mandate becomes applicable” from March 01, 2022

This is a structures and processes was established by EMA during the COVID pandemic on a more permanent footing. The agency is now responsible for medicine shortage monitoring, that may cause a crisis situation, and also reporting shortages of critical medicines during a crisis.

Source: https://www.ema.europa.eu/en/news/regulation-emas-extended-mandate-becomes-applicable

FDA released final guidance on “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C”

Date of news: March 03, 2022

The objective of this FDA guidance is to provide clarity on FDA’s expectation from industry and FDA staff regarding prompt initiation of voluntary recalls to recover unsafe goods from the market.

The document discusses about required preparations by firms with respect to distribution chain of distributors, and manufacturers’ procedure to initiate recalls; identification and prompt action; and to promptly communicate recall regarding information, press releases or any other public notices.

Source: https://www.fda.gov/media/123664/download?utm_medium=email&utm_source=govdelivery

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