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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

2014-09-12

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 11, 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.

 
2014-08-15

The EU’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators PilotExternal link icon (IGDRP). The EU is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU.

 
2014-08-11

Following consultation within the TGA and with relevant stakeholders including Industry and consumer groups, a number of EU/ICH Guidelines have been adopted by the TGA, effective 1 August 2014.

 
2014-07-22

The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk has reached Step 4 of the ICH process and is now entering the implementation period (Step 5). The final draft isbeing recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.

 
2014-07-14

FDAs Center for Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances. This document provides a concise overview of the status of various guidelines that are currently in process:

 
 
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