Pharma GMP News of the Week: 10-July-2022

Period: July 3, 2022 to July 9, 2022

FDA published draft guideline “Identifying Trading Partners Under the Drug Supply Chain Security Act”

Document published on: July 5, 2022

The FDA has issued the guideline to assist industry and stakeholders in understanding how to categorize the entities in the drug supply chain as per the DSCSA.

Source:  https://www.fda.gov/media/159621/download 

FDA published draft guideline “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry”

Document published on: July 6, 2022

The purpose of this guideline is to identify the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards.

This guideline is applicable for manufacturers,  dispensers, wholesale distributors, and repackagers who are engaged in transactions of “products” as defined in section 581(13) of the Food Drug & Cosmetic Act. 

Source: https://www.fda.gov/media/90548/download

News from EDQM “New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication”

Document published on: July 7, 2022

The purpose of this guideline is to provide guidance for the authors of monographs. This is the mode of communicating the principles for the elaboration and revision of monographs to the users of the Ph. Eur., specifically licensing authorities, industry, and official medicines control laboratories. This document also provides guidance with elaboration of specifications intended for inclusion in MA applications.

Source: https://www.edqm.eu/documents/52006/66555/02-technical-guide-elaboration-monographs-8th-edition-2022.pdf/46b07f46-779d-687d-1455-74d8a9a515ee?t=1656321894803 

News from TGA “TGA updated recall procedure”

Month of news: July 2022

Two key modifications in the updated procedure are the removal of a section on crisis management guidance and inclusion of details on agency expectation to get in relation to recalls.

Source: https://www.tga.gov.au/sites/default/files/uniform-recall-procedure-therapeutic-goods-urptg.pdf

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