GMP News - Quality Assurance

12.11.13

Revised Annex 16: Comments of the European QP Association

In July this year, the European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". The European QP Association has provided a comprehensive summary as feedback to the proposal. Read more.

30.10.13

New USP Draft on Plastic Materials

In a draft for a new General Chapter on "Plastic Materials", the USP has described the requirements set today on plastic packaging materials. It has also defined when plastic materials are suitable for use as packaging systems for medicinal products. Read more details about the publication in the Pharmacopeial Forum.

23.10.13

ECA Foundation releases free GMP WebApp

A huge benefit of smartphones and tablet PCs and apps is that you can access relevant information any time anywhere. Now you can also quickly and comfortably access information with regard to news and regulations in the GMP environment - and more. For that purpose the ECA Foundation took advantage of its longstanding experience to develop a free of charge smartphone and tablet PC WebApp. Find out more....

22.10.13

New FDA Requirements on Labelling and Container Labels

In a new Guideline, the FDA laid down concrete provisions regarding how printed packaging (labels, cartons, etc.) should be designed to ensure the readability of the most important information. The purpose is to enhance the safe use of medicinal products and to reduce the number of medication errors. Read more in the News.

16.10.13

U.S. Government Shutdown: Consequences for the FDA

In the USA federal agencies are facing a government shutdown. But what does that mean for the U.S. Food and Drug Agency FDA? Will inspections be performed? And what about submissions? Read more.

26.09.13

EMA QA Document for the Implementation of the Variations Guidelines

The European Medicines Agency (EMA) has published a document with practical questions and answers to support the implementation of the variations guidelines. Read more.

26.09.13

EMA publishes Concept Paper on the Revision of the Finished Dosage Form Guideline

The EMA has recently published a concept paper on its website that initiates the revision of EMA's Guideline "Note for Guidance on Manufacture of the finished dosage form". Read more here.

11.09.13

Revision of the USP Chapter on Packaging and Storage Requirements

The proposed revision of Chapter <659> on Packaging and Storage Requirements shall help ensuring in the future that the definition of the "single-dose-containers" term is used correctly. In addition, the storage conditions for medicinal products have been defined completely. Read more here in the News.

11.09.13

FDA started Initiative for DUNS Numbers of Pharmaceutical Sites

In one of our last News, we reported about the DUNS numbers for the identification of pharmaceutical sites in Site Master Files. Last year, the FDA also started an initiative for the DUNS numbers. Read more.

04.09.13

Have you ever heard about the Dun and Bradstreet Verification in the EU Site Master File?

With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. The EU Site Master File contains a few essential changes to the previously applicable PIC/S Guideline PE 008-3. In the new version for example under section ... read on.

28.08.13

EU-GMP Guide: final Chapter 2 on Personnel published

The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. The basic principles of the chapter have been unchanged; however a few new approaches have been added. Read more.

21.08.13

Batch Record: who needs to review?

The Qualified Person (QP) often reviews the batch documentation personally prior to certification of the batch. But is the QP obliged to do so? Read here, why the QP is not.

21.08.13

FDA Inspection Reports: What is What

Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.

14.08.13

New FDA Guidance on the Finalization of several FDA Draft Guidances

On 7. August 2013 the US FDA published a notice in the federal register entitled: Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances. Read more.

14.08.13

WHO revises GMP Guide regarding the Principles of GMP

In July the WHO has published a revised version of their Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" for comment. Read on.

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