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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

2014-09-26

The application forms for requests for certificates of suitability (CEPs) have been updated.

 
2014-09-26

Shortly before the next PIC/S Committee Meeting on 20-21 October 2014 in Paris, the Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership.

 
2014-09-23

The use of products with non-declared pharmacological activity or “other illegal medicines”, often from uncontrolled sources but also purchased from the legal market, is still a major problem within Europe.

From 10-11 September 2014, the second symposium on combating counterfeits and other illegal medicines took place at EDQM. Representatives from forensic and customs laboratories, national medicines and food authorities, enforcement groups and the European Commission were invited to shed light on the problem of falsification of medicines.

 

 
2014-09-23

A comprehensive report of the last ICH meeting, which was held in Minneapolis, MN, USA, on 4-5 June 2014, is now available on the ICH website under the SC Reports page.

 
2014-09-12

According to the Indian financial portal Business Standard and Money Control, the US FDA has started a surprise audit at the Halol Plant of SUN Pharma on Monday 8, 2014.

 
2014-09-09

The Active Pharmaceutical Ingredients Committee, APIC, has recently published a comprehensive How to do Document regarding electronic Common Technical Documents. eCTD is a topic of increasing interest in the pharmaceutical environment. This guideline document focuses entirely on the first submission of an API dossier.

 
2014-09-02

The European Commission has published a revised version of Part II of the EU GMP Guide – Basic Requirements for Active Substances used as Starting Materials. According to the EC this became necessary due to changes in various Annexes of the GMP Guide. Hence Part I can no longer be followed for active substances used as starting materials.

 
2014-09-02

The European Commission has published the final version of the following revised chapters of the EU GMP Guide:

The deadline for implementation is 1 March 2015.

 
 
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