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GMP Subject Downloads


1. GDP Audit Checklist
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2. GMP Audit Checklist
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3. Computer System Validation in the EU
a step-by-step guide to implementing a computer validation program


4. Risk Management
established methods of risk analysis
incl. ICH Q9


5. Preparing for the EU GMP Inspection
similarities - and subtle differences - between FDA and EU GMP inspections


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News about GMP/cGMP


The EMA has published a draft guideline on similar biological medicinal products on May 2, 2013, which is now open for public consultation.


The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database is a key deliverable of the new European Falsified Medicines Directive and will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.


Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. Following Switzerland, Australia is the second country to be adopted and listed by the European Commission.


EC: Commission implementing decision


India has recently published the revised draft guidelines for the issue of the “Written Confirmation” for APIs exported to the EU in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.


This month the FDA has published the final version of the Guidance for Industry "Blood Establishment Computer System Validation in the User´s Facility". The FDA issued this guidance to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.


On 16 April 2013 the European Commission published Version 4.1 of the Q&A document regarding the importation of APIs to the EU. This version contains two new questions (2A and 10A) and their corresponding answers. Question 11B on atypical active substances –which was only added last week - has been removed as additional discussions with Member States are needed.


The European Medicines Agency and the European Commission have renewed their confidentiality arrangement with Health Canada, the Canadian regulatory authority for medicines, for a further five-year period.

The regulatory authorities will continue their successful cooperation and further extend the exchange of information.


As previously announced by the SFDA, the newly revised "Good Supply Practice for Pharmaceutical Products (GSP)" was recently adopted by the Ministry of Health. It will enter into force on June 1, 2013.

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