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TOP 5 GMP Downloads

1. GDP Audit Checklist
for the Storage and Transport of Pharmaceuticals


2. Quality Agreement
Standard draft to adapt and extend


3. Premises
Official requirements | material flow | room classes | and much more...


4. GMP Audit Checklist
for Pharmaceutical and API Manufacturers


5. Documenting Process Validation
A Drugmaker‘s Guide – step-by-step manual based on real-world examination experience


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News about GMP/cGMP


The new revision of Annex 1 mentions a new term, Grade A air supply, but no definition of this new term is given in the revised Annex. Inspectors and Industry therefore need an interpretation of this term, especially as a provision of a grade A air supply is one of the most significant changes in Annex 1.


PIC/S has published a revised version of the recently adopted Recommendation for the technical interpretation of Annex 1 to the PIC/S GMP Guide, which has been prepared by Switzerland / Swissmedic. The Recommendation entered into force on 1 January 2010.


On January 12, 2010, as the first phase of the agency's Transparency Initiative, FDA launched a web-based resource called FDA Basics that provides basic information about the agency and how it does its work.


An informal Working Group within PIC/S has developed an example of methodology for the implementation of Quality Risk Management (QRM) in the pharmaceutical industry.


EMA (EMEA) has published their 2010 Work Plan for the GMP/ GDP Inspectors Working Group on January 12, 2010. Among other themes, there are several GMP and GDP topics concerning the EU GMP Guide identified as "high priority"  in 2010. Topics with "low priority" and all further informations concerning the Work Plan for 2010 you find in the document linked below.


The European Commission's Draft Group Enterprise and Industry launches a public consultation on Part III of the good manufacturing practices laying down guidance to manufacturers in preparing site master files. The European Commission published this draft document on January 12, 2010. The consultation period ends on March 31, 2010.


EMA (former EMEA) is currently updating chapters 3 and 5 of the EU GMP Guide concerning self-contained facilities for critical products. In some circumstances it is necessary to manufacture certain products in dedicated and self-contained facilities where the risks to patients posed by accidental cross contamination of other products is high.

Despite the the documents are still in revision, there are already some points to consider:


Due to a revision of Chapters 1 and 2 of the EU GMP Guide in 2010 there should be an alignment with the concepts described in ICH Q10.

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