GMP News - Quality Assurance


EMA issues Draft Guideline on Similar Biological Medicinal Products for public consultation

EMA's new draft  "Guideline on Similar Biological Medicinal Products" is open for comments until end of October 2013. More details about the guideline and its scope can be found here.



GMP Guideline Manager Version 15.0 released

The European Compliance Academy's (ECA) GMP Guideline Manager CD is a very useful tool, providing all relevant guidelines on a single CD. It is distributed to all members of the ECA. This year the CD was issued in its 15th edition. Read more.



Is there going to be "GMP Rating"?

Janet Woodcock from the FDA has published a very interesting report in the Nature Publishing Group. As leader of the CDER, she has one of the most important positions within the FDA. Read more here.



Written Confirmations: Time is running out - new EU Progress Report

The EU Commission has published a progress report giving an overview on 20 major countries and their status of preparation for adhering to the new rules. It seems there are still quite a few challenges. Read more.



Change Control: New SUPAC Guidance published

FDA has published a new draft Guidance for Industry: SUPAC - Manufacturing Equipment Addendum. The guidance document is being distributed for comment purposes. Read more.



FDA publishes GMP Requirements for "Combination Products"

As of 22 July 2013, cGMP requirements on combination products will apply in the USA as 21 CFR Part 4. But what are combination products? These are composed of medical products, medicinal products, and ... Read more here.



Sample Documentation on EU Site Master File published

The introduction of the EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description. The very precise instructions have all disappeared. New requirements have been added. A sample documentation shows how to take into account the new requirements in a SMF. Read more here.



Written Confirmations - How is the EU pharmaceutical Industry dealing with that?

To find out how pharmaceutical companies in the EU are seeing the challenges with the Written Confirmations, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. Read more.



India issues Guidelines for Certification of API Exports to EU - can the EU accept this Certification?

Guest Blog: Uday Shetty, Executive Director of Drug Regulations, sees some challenges with India's move to issue Written Confirmations. Read more.



Revision of the GMP Matrix: US GMP vs. EU GMP

One often wonders which differences do exist between the US American cGMP regulations (21 CFR 211) and the EU GMP Guide - and which parallels they have. What's the place for ISO 9001 in these phama specific regulations? In order to support answering the questions, the ECA developed a Good Practice Guide "GMP Matrix" a few years ago. Now, this matrix has been completely revised. Read more.



Why is GMP so important - Answers from the FDA

Why is GMP so important? This question is answered by the FDA in an article on facts about cGMPs. The FDA gives the answers in a compact form in 6 paragraphs on two pages. Read more.



MHRA and NIBSC get new Structure on 1 April 2013

The National Institute for Biological Standards and Control (NIBSC), currently part of the Health Protection Agency (HPA), will officially become a new 'centre' of the Medicines and Healthcare products Regulatory Agency (MHRA) alongside the Clinical Practice Research Datalink (CPRD). More details can be found here.



SFDA rewards Whistleblowers

China encourages the public to report criminal activities concerning food and drug. Read more.



WHO GMP approaching EU-GMP

The current good manufacturing practices (GMP) for pharmaceutical products of the WHO are going to be updated. Read more.



Outcome of the public Consultation on the Review of the Variations Guidelines

The European Commission has published a document summarising 40 contributions made by stakeholders. Read more.


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