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GMP Inspections in Europe: Proven Strategies on How to Prepare

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TOP 5 GMP Downloads

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


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


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


4. Technical Agreement
and Delimination of Pharmaceutical Responsibilities.


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


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News about GMP/cGMP


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.


The ICH has published the final version of the Q&A document to the ICH Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The document was prepared by the Q7 Implementation Working Group in order to clarify uncertainties related to the interpretation of some sections.


As previously announced by the ICH, new training material to ICH documents will be published and updated on the ICH website on a regularly basis. The intention behind this supporting service is to facilitate the implementation of ICH Guidelines by resolving uncertainties which have arisen during the application of the guideline.


The WHO has published the final versions of the

Both documents were released as part of the Technical Report Series 992, which was published by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in May 2015.


The WHO has published an interesting new Guidance named “Technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products”.  The target readership includes regulators, logisticians and pharmaceutical professionals in industry, government and international agencies.


The FDA has issued the draft guidance “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products”. This guidance has been developed to address a lack of clarity concerning chemistry, manufacturing, and controls (CMC) in a marketing application. It explains whether CMC information represents an established condition or a “regulatory commitment” that, if changed following approval, requires reporting to the FDA.


The EMA has released a concept paper on new guidance for importers of medicinal products. GMP/GDP Inspectors Working Group agreed to draft a specific guidance for import authorisation holders. This document most likely would take the form of a new annex (Annex 21). The deadline for comments is 29 August 2015.


The ICH Steering Committee (SC) will meet in Fukuoka, Japan from 6 to 11 June to discuss ongoing harmonisation activities. One item on the agenda is the development of the ICH Q12 Guideline on Lifecycle Management.


The IPEC Federation (International Pharmaceutical Excipients Council) has published a three-page position paper concerning the risk-based approach of the EU Guidelines following the principles of Quality Risk Management according to ICH Q9. The IPEC-paper applies to the community regulated under the EU Risk Assessment Guidelines.


The European Commission has published the responses to the public consultation on the revision of Annex 15: Qualification and Validation.


Following a three years period since publishing the “Biologics Price Competition and Innovation Act” and therein the “Approval Pathway for Biosimilar Biological Products”, the FDA has now finalized the following three guidance documents on Biosimilars:

Guidance for Industry - Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Guidance for Industry - Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Guidance for Industry - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.

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