GMP News - Quality Assurance

11.05.23

EDQM: Updates on CEP 2.0

As part of the implementation of the new "CEP 2.0", the EDQM has now provided further information on its website.  

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10.05.23

Switzerland: New Declaration of the Responsible Person for foreign Manufacturers

Swissmedic has specified the conditions for the submission of an audit report by the Responsible Person as proof of GMP compliance of foreign manufacturers.

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10.05.23

EDQM: CEP Report

In March 2023, the EDQM once more prepared its "CERTIFICATION MONTHLY REPORT" on the topic of "CEPs" and has now published it in the newsroom of the EDQM website.

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03.05.23

WHO: Excipients GMP Guideline published for Comments

In March 2023, the WHO published the first draft of the guideline "WHO good manufacturing practices for excipients used in pharmaceutical products" on its website for comments. The public comment period ends on 26 May 2023.

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03.05.23

GMP Update: Consequences from the New EU Commission Proposal

The EU Commission has published the proposal for the revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. There are also GMP-relevant changes.

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03.05.23

GMP for Cosmetic Products

The U.S. Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP). Now the agency announced a virtual public meeting on Good Manufacturing Practices (GMP) for Cosmetic Products to be held in June this year.

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26.04.23

Which Test Sets are used in the 100% Visual Inspection?

In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account.

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19.04.23

APIC: FAQs on Data Integrity

In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

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19.04.23

FDA Warning Letter: Inadequate API testing

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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11.04.23

How can Sponsors Demonstrate Oversight for Delegated Activities?

A new Q&A at EMA´s Good clinical practice (GCP) website addresses how sponsors can demonstrate oversight for those activities that are delegated by a written contract.

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05.04.23

Laboratory Data Integrity issues once again caused a Warning Letter

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

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05.04.23

FDA Stops Voluntary Cosmetic Registration Program

The FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023. This follows the agency's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act" (MoCRA). According to the agency, the new law gives the FDA new authorities that will help ensure the safety of cosmetic products.

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05.04.23

ICH Information Material on the ICH Q9 revision Quality Risk Management

Since 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation.

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29.03.23

11th Edition of The International Pharmacopoeia

The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.

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28.03.23

FDA Warning Letter: Lack of Temperature and Humidity Control

The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

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