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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


On Febraury 3, 2010 the European Commission published the revised Annex 6 "Manufacture of Medicinal Gases"  of the EU GMP Guideline. The Annex' deadline for comming into operation is Juliy 31, 2010.  


On February 3, 2010 the European Commission published the revised Annex 6 "Investigational Medicinal Products" of the EU GMP Guideline. Deadline for comming into operation is until July 31, 2010.


While EMA (EMEA) welcomes questions on its activities and the regulatory framework within which it operates, specific questions on the interpretation of GMP requirements should be addressed, ideally by the Qualified Person, directly to the relevant supervisory authority of the Member State in which the manufacturing authorisation holder is located. Manufacturers based in third countries should make contact through the Qualified Person of the authorised importer.


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.

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