Pharma GMP News of the Week: 13-March-2022

Period: March 6, 2022 to March 12, 2022

EDQM published batch release guideline on Pandemic COVID-19 vaccine (Recombinant Spike Protein)

Date of news: March 8, 2022

Source:  https://www.edqm.eu/sites/default/files/medias/fichiers/COVID-19/guideline_for_pandemic_covid-19_vaccine_recombinant_spike_protein080322.doc

FDA released draft guidance on “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs”

Date of news: March 09, 2022

The objective of this revised draft FDA guidance is to addresses and comply the requirement as amended by the Drug Supply Chain Security Act (DSCSA) of Federal Food, Drug, and Cosmetic Act (FD&C Act).

These compliance requirements are for

• Drug product manufacturers

• Wholesale distributors

• Repackagers

• Dispensers

The verification system required to be used to determine to be suspect and the quarantine and disposition of a product determined to be illegitimate.

The guidance also covers notification requirement when it is determined that the product is not an illegitimate product and cleared by manufacturer, wholesale distributor, repackager, or dispenser.

The guidance also covers the process for responding to requests for verification and processing returns.

Source: https://www.fda.gov/media/117950/download

FDA released final guidance on “Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions”

Date of news: March 11, 2022

Source:  https://www.fda.gov/media/156729/download

MHRA has published blog “Compliance Monitor process (Part 1) – An introduction” on its website.

This is the 1st part of blog series on the Compliance Monitor process. This process will be piloted by the MHRA from April 2022.

Potential benefits of the program are:

The company will benefit from being able to concentrate on the delivery of the required improvements without having to divert their resources to manage MHRA supervision inspections to assess compliance remediation activities.

Under this pilot program, the GMP and GDP remediation will be supervised by eligible consultants that will act as Compliance Monitors. The potential benefits are:

• Agency resources can concentrate on routine risk-based inspection programme.

• Minimize potential shortages medicines supply using risk-based supervision and monitoring.

Date of news: March 11, 2022

Source:  https://mhrainspectorate.blog.gov.uk/2022/03/11/compliance-monitor-process-part-1-an-introduction/

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