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News about GMP/cGMP


A new version of Annex 16 of the EU GMP Guide "Certification by a Qualified Person and Batch Release" has been published by the European Commission. This version will become operational on 15 April 2016.


During a consultation on data management, bioequivalence, GMP and medicines inspection held by the WHO in 2015, a revision of the Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms was discussed with the inspectors.


On 1 September 2015, the European Commission, the European Medicines Agency (EMA) and the World Health Organization (WHO) started a “step up cooperation” on EU medicines to help protect global health. The organizations will share certain non-public information on the safety, quality and efficacy of medicines already on the market or under review in the EU, or pre-qualified or under review by WHO.


Almost two years after publishing a concept paper on Annex 17 – Parametric Release – of the EU GMP Guide, the European Commission has now published a comprehensive draft version of Annex 17. The seven-page document is now open for public consultation until 11 December 2015.


According to the Financial Times (F.T.com) the Indian Pharmaceutical Industry is in the midst of a credibility crisis. So far, the US FDA has banned imports from 39 Indian drug makers, all of which were once permitted to produce medicines for US patients. This year, already six Indian companies have had their manufacturing sites blacklisted by the FDA.


On 24 August 2015, the US Food and Drug Administration (FDA) held a public meeting with several industry associations to discuss its request for quality metrics from drug manufacturers. This was the first opportunity for industry representatives to give feedback to the FDA’s plan to request and use quality metrics. Quality metrics shall be used to assess the quality of drug and biologic manufacturing on one hand. On the other hand a careful analysis of quality metrics shall help FDA to better identify which facilities are at the highest risk for quality problems. The final guideline is expected for 2016.


Three new public consultations concerning good manufacturing practices for investigational medicinal products (IMPs) were opened on 28 August 2015 by the European Commission and will continue until 24 November 2015:


The ICH Expert Working Group (EWG) responsible for maintenance of the Q3C Guideline has revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK) which was listed in ICH Q3C(R5) as a Class 3 solvent (“solvents with low toxic potential”).


Clarification for products outside the scope of the ICH Q3D Guideline

The European Pharmacopoeia Commission published its implementation strategy for the International Conference on Harmonization’s Q3D guideline for elemental impurities, in a press release dated 28th April 2015. The European Pharmacopoeia Commission decided to reproduce verbatim the ICH Q3D guideline in the Ph. Eur. chapter 5.20, the “Metal catalyst or metal reagent residues” chapter.


The FDA has published a Draft Guidance entitled „Request for Quality Metrics“ after seeking input from a number of large industry stakeholders.

The document describes a set of measurements to help the FDA evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics. These include prescription drugs and certain biological products. The guidance also encourages these manufacturers to conduct robust quality measurements on their own products.


The ICH Steering Committee (SC) and twelve ICH Expert Working Groups met in Fukuoka, Japan from June 5 -11, 2015.

The SC agreed on the key issues relating to the reform of ICH in terms of the Articles of Association, funding model and membership. The new ICH Association under Swiss law  is expected to be established over the coming months with the aim of being operational starting in 2016.


The Addendum of the ICH M7 Guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2b of the ICH Process in June 2015 and is now entering the consultation period (Step 3).


The EMA has published the draft guideline on manufacture of the finished dosage form for comments. This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95).


Last week the European Commission officially added Israel and Brazil to the list of third countries outside the European Union that have manufacturing standards and supervision of APIs equivalent to those of the EU.


The illegal sale of medicinal products to the public has increased dramatically. Mostly they are distributed via Internet. To better protect consumers, as of 1 July 2015, a new common EU logo helps to identify the websites which are operating legally. The logo links to the website of the national competent authority and can be trusted, if the operating online pharmacy/retailer is listed. A press release of the British MHRA shows the necessity of such protective measures:

Dangerous counterfeit and unlicensed medicines worth £ 15.8 million have been seized in a record haul by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) as part of ‘Operation Pangea VIII’. The seizures are a result of a crackdown on the illegal internet trade of medical products that yielded £ 51,6 million worth of items from 115 different countries globally. The majority of the products seized originated from India, China, Hong Kong and Singapore.

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