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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

2014-07-22

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Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances.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:

 
2014-07-08

Last week the FDA issued several policy documents regarding compounded drug products for human use, as part of the agency’s effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists.

 
2014-07-01

The Active Pharmaceutical Ingredients Committee (APIC) has recently released two new documents:

 
2014-07-01

EU regulators have unveiled a new logo which will appear on the websites of all authorised online pharmacies known to provide authentic medicines. This represents one more step towards helping European consumers to avoid counterfeit or falsified medicines.

 
2014-06-25

The British authority MHRA have published meeting minutes of their GMP/GDP Consultative Committee that took place on 11th April 2014 in London. Two times a year MHRA meets with different industry groups/associations to inform and discuss about latest GMP and GDP issues. Inter alia, MHRA gave an update on the GMP/GDP documents currently under revision or in preparation, respectively.

 
2014-06-25

The Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).

In May 2014 Australia was accepted as an assessor in the EDQM's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs).

 
2014-06-17

EMA has published the long awaited Qualified Person (QP) declaration template and accompanying guidance concerning GMP compliance of API manufacture. The much discussed draft version dates back to 2010.

 
 
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