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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

1. GMP Audit Checklist
The GMP Audit Checklist works great for both sides - the auditor and the inspected company.


2. GDP Audit Checklist
More than 700 questions with reference to regulations for preparing and carrying out GDP audits.


3. Quality Agreement
Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.


4. Creating a Master Plan for Drug Warehousing, Transportation and Distribution
Guide to preparing a company for compliance with Good Distribution Practice (GDP).


5. A Process Approach to Pharmaceutical Quality Systems
A Guide to ICH Q10 Compliance


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News about GMP/cGMP


The government of France has proposed a new labelling claim to the European Commission – a pictogram – indicating that the manufacturing operations of excipients, the manufacturing of the active substance, its production or packaging were carried out within the territory of the European Union or Member States of the European Free Trade Association (EFTA).


Professor Guido Rasi took office as Executive Director of the European Medicines Agency (EMA) on 16 November 2015. He had already held this position from 2011 - 2014 before he had to step down due to a formal error in the selection procedure.


The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.


Already discussed at a WHO-meeting in April 2014, the WHO has now published a 35-pages draft to the Guideline for Good Data and Record Management Practices.


The U.S. FDA (CDER, CBER, CDRH) has published a draft guidance on the "Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use".


China Food and Drug Administration (CFDA) has published four new guidelines explaining its approach to on-site inspection for medical device good manufacturing practices. The documents are intended to strengthen the supervision and management of medical device manufacturing and to offer guidance to regulatory departments during on-site inspections or when evaluating inspection results. The main document covers an overall approach, while the other three focus on in-vitro diagnostics, sterile and implantable medical devices.


This month the British MHRA (Medicines and Healthcare products Regulatory Agency) signed a Memorandum of Understanding (MOU) with CDSCO (Central Drug Standard Control Organisation), its counterpart in India. This comes as no surprise, considering that nearly 25% of UK medicines are made in India.


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”).

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