GMP News - Quality Assurance

11.10.23

What is "Root Cause Analysis (RCA)"?

RCA is an essential part of CAPA processes in the pharmaceutical industry. It helps to ensure that quality problems are solved effectively. There are different tools to get to the real cause of a problem.

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05.10.23

EMA: Updates in the Product Lifecycle Management (PLM) Portal

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).

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05.10.23

BfArM/PEI: Guideline "Designation of Medicinal Products" published

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.

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05.10.23

EDQM: CEP 2.0 implemented

Since beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only.

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04.10.23

FDA issues new Guidance on Remote Oversight Tools

The FDA has published a new guidance document on the possible use of alternative methods in the preparation of inspections or in place of inspections for marketing authorisation applications that are still pending.

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04.10.23

USP: Excipient Stimuli published for Comments

In the beginning of September, the stimuli document "Proposed Definitions of Excipient Components- Revisions to 2018 Definitions- PF 49(5)" was published for comment on the website of the Pharmacopeial Forum of the USP. Comments on this draft can be submitted until 30 November 2023.

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04.10.23

FDA Warning Letter for OTC Manufacturer in Arizona

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

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04.10.23

EMA: Q&As on the Topic of "Parallel Distribution" updated

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

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04.10.23

Warning Letter: A Serious Quality Oversight Issue

The FDA recently issued a Warning Letter to a pharmaceutical company in Florida (USA) for violating CGMP regulations and expectations on Quality Oversight.

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28.09.23

Annual Report Forms for Postmarketing Requirements

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.

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27.09.23

USP: Chapter "Weighing on an Analytical Balance <1251>" published for Comments

Like the USP chapter "Balances <41>", the chapter "Weighing on an Analytical Balance <1251>" has been updated and revised. The new version of this chapter has now been posted on the USP Pharmacopeial Forum website for comment. Comments on this draft, which is based on the previous version from May 2018, can be submitted until 30 November 2023.

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27.09.23

CAPAs after Validation Deficiencies

The FDA Warning Letters are a very good source to get to know how the FDA reacts to GMP deficiencies. In a current Warning Letter, the FDA comments on deficiencies in the context of process validation, among other things. What "CAPA" measures did it call for?

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26.09.23

FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

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20.09.23

Electronic Submission Portal for Cosmetics

The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct).

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20.09.23

US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.

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