Pharma GMP News of the Week: 29-August-2021

Period: August 22, 2021 to August 28, 2021

FDA: No plans yet to resume onsite GMP foreign inspections

US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not “mission critical” during the COVID-19 pandemic.

Along with the mission-critical and prioritized domestic inspections completed from March 2020 through March 2021, FDA also looked at existing oversight tools and authorities and considered ways to optimize our surveillance and weave new approaches into our oversight scheme. These included:

a. Reviewing records and information requested from facilities in advance or in lieu of certain drug and biological product inspections to support regulatory decisions and actions as authorized under section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act.11

b. Applying remote assessments for individual program areas to evaluate facility records.

c. Leveraging information shared by trusted state, local, tribal, and territorial regulatory partners.

d. Leveraging information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements.

e. Sampling and analytical testing of FDA-regulated products both domestically and at international borders.

f. Refusing entry of unsafe imported products into the U.S

From March 2020 through March 2021, FDA conducted a total of 821 mission critical inspections, including 29 in foreign countries. FDA will be resuming onsite inspections for active pharmaceutical ingredient (API) firms in India that have received an official action indicated (OAI) or a 483 report. These firms have been “prioritized” as mission critical and plans are to inspect them soon.

As per FDA, the staff in the India office has those assignments now. FDA has two detailees in India and is working to post additional staff there temporarily. FDA have quite a few follow-up OAI inspections there to get to.

As per FDA, alternatives will not replace onsite inspections
 
As per FDA, there are no plans to replace onsite inspections with remote audits and records requests. As per FDA’s perspective, records requests and remote inspections do not meet the statutory requirements for a boots-on-the-ground inspection.

To know more, visit: Here

TGA reduces timeframe for publishing adverse event reports

Date of release: August 19, 2021

With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our IT systems, the Therapeutic Goods Administration (TGA) is making reports for medicines and vaccines publicly available more quickly.

The changes will reduce the time between adverse event reports being accepted into our database and published on the Database of Adverse Event Notifications – medicines (DAEN) from 90 days to 14 days.

As per the TGA website, Reports will now be made public prior to in depth TGA analysis of the data to check for patterns of adverse events that may or may not indicate a safety issue (signal detection). If we identify a safety signal, we investigate and communicate any important safety information to the public.

Source: https://www.tga.gov.au/behind-news/tga-reduces-timeframe-publishing-adverse-event-reports

The ICH Q13 Step 2 presentation available now on the ICH website: Continuous Manufacturing of Drug Substances and Drug products

Date of release: August 23, 2021

Further to the ICH Q13 draft document reaching Step 2b of the ICH Process on 27 July 2021, the Step 2 Informational Presentation developed by the ICH Q13 EWG has been finalised.

The Step 2 Informational Presentation and additional information can be found on the ICH Q13 Guideline page.

Download presentation

Medical Devices Coordinating Group of the European Commission (MDCG): Guidance on repackaging and relabeling processes of devices

In August 2021, MDCG, published a guideline for notified bodies, distributors, and importers of medical devices.

This guidance is intended to provide assistance to notified bodies to implement requirements established by MDR and IVDR with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

Source: MDCG – Guidance for notified bodies, distributors and importers on certification activities

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