Pharma GMP News of the Week: 19-December-2021

Period: December 12, 2021 to December 18, 2021

FDA publishes draft guidance on “Inspection of Injectable Products for Visible Particulates”

Date of publication: December 16, 2021

The US Food and Drug Administration (FDA) on issued a draft guidance on “Inspection of Injectable Products for Visible Particulates” to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.

The draft guidance provides clarity that meeting an applicable U.S. Pharmacopoeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.

The draft guidance provides information regarding the development and implementation of a holistic, risk-based approach to control visible particulate. It describes about product development, manufacturing controls, visual inspection techniques, particulate identification, investigational and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.

Source: https://www.fda.gov

Download: https://www.fda.gov/media/154868/download

European Pharmacopoeia (FP) Supplement 10.8 is available now

The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available on EDQM WebStore.

This is applicable for 39 European countries as of 1 July 2022.

This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur.

Source: https://www.edqm.eu/

FDA publishes draft guidance on “Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents”

Date of publication: December 16, 2021

As per the FDA, “FDA is issuing this guidance to clarify how the Agency interprets existing references to section 201(h) of the FD&C Act and how we intend to reference the definitions of “device” and “counterfeit device” going forward. This guidance is intended to provide clarity on references to the terms “device” and “counterfeit device” – as well as references to section 201(h) of the FD&C Act – in guidance, regulatory documents, and other communications and documents for FDA staff, industry, and other stakeholders.

Download: https://www.fda.gov/media/154866/download

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