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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 Feburary 16, 2010 the FDA published a Warning Letter concerning cGMP-Violations caused by lack of Hygiene during the manufacturing process and inaccurate personal hygiene.


The Committee for Medicinal Products for Veterinary Use (CVMP) adopted a “Concept paper on the need for revision of the guideline on stability testing for applications for variations to a marketing authorisation” (EMA/63033/2010-CONSULTATION) for a 2-month period of public consultation. Revision is required because of recent changes to the underlying variations legislation.


The European Medicines Agency has launched a three-month public consultation on its Road Map to 2015, coinciding with its 15th anniversary on 26 January 2010.


On January 14, 2010, the US Food and Drug Administration published a guidance that is intended to ensure the availability of medically necessary drug products (MNPs) during emergencies such as an influenza pandemic. The guidance cites the Center for Drug Evaluation and Research’s (CDER’s) definition of a medically necessary drug product as any drug used to treat or prevent a serious disease for which no appropriate substitute is adequately available.


ICH's "Quality Implementation Working Group" offers in 2010 several Integrated Implementation Training Workshops for ICH Q8, Q9 and Q10.


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.

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