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GMP Subject Downloads


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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


This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. A presentation to the WHO Expert Committee is planned for October 2014.


The European Commission has published the final version of Chapter 6 Quality Control of the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use on April 3, 2014.

The revised document will enter into force on 1 October 2014 and then supersede the previous version of 2005.


According to the China Food and Drug Administration CFDA, the Chinese government on Monday unveiled a revised regulation on the supervision of medical equipment to enhance its safety and effectiveness and safeguard public health.


On 1 April 2014, the European Commission has published a “Question and Answer” document (version 1.0, March 2014) responding to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.


The FDA plans to reduce its number of routine GMP inspections in the U.S. by 40 % and thus to scale up its inspections overseas. This new strategy shall improve the quality of drugs imported into the U.S. and will bring the FDA closer to achieving its longtime goal of bringing parity to domestic and foreign inspections.


The EMA has published the final version of the long awaited Guideline on Process Validation “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” on February 24, 2014. It will enter into force in August 2014.


The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics.


The FDA has published a Draft Guideline for Industry entitled Analytical Procedures and Methods Validation for Drugs and Biologics. The revised document supersedes a draft of the year 2000 and – once finalized – will also replace the 1987 FDA Guidance on Submitting Samples and Analytical Data for Method Validation.

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