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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


A linguistic review of product information in all EU languages is performed. This should ensure high quality and consistent product information of Centrally Authorised Products in all Member States.


On February 26, 2010 EMA announced, that in recognition of World Rare Disease Day (the last day of February), the FDA and the EMA have agreed to accept the submission of a single annual report from sponsors of orphan products (drugs and biologics) designated for both the US and the EU.


The EUs Comittee on Herbal Medicinal Products (HMPC) has established the ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’. The list is being gradually developed through entries of structured information relating to individual herbal substances or preparations.


The European Commissions 1997 publication on Radiation Protection, concerning Radiation Criteria for Acceptability of Medical Radiological Equipment Used in Diagnostic Radiology, Nuclear Medicine and Radiotherapy, is going to be updated this year. According to the Council Directive 97/43/EURATOM the EU Member States' competent authorities shall adopt specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary. This includes, if appropriate, taking the equipment out of service.



Updated CEP (Certificate of Suitability) application forms for new applications and revisions/renewals were published on February 9, 2010, by the EDQM (European Directorate for the Quality of Medicines & HealthCare).


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.

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