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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 5, 2010 FDA published a guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials. The results could be less costs and more efficient patient studies.


On January 14, 2010 FDA published a Warning Letter, concerning amongst others a lack of cGMP violations in training affairs.  As you can see there, training-affairs are an important GMP aspect and there will be serious consequences when ignoring them.


When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.


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.

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