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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 17, 2010 the german APV (Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.) published an interesting Classification of  Inhaler Systems, contributed by  Carsten Kremer PhD.


USP has recalled USP 33–NF 28 because of text errors that were introduced during conversion to a new format. The USP intends to reissue the publication in March 2010. Further information about the recall is available in two public notices released on January 8, 2010 and January 12, 2010.


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.  

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