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News about GMP/cGMP

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Drug Evaluation and Reseach (CDER) has published its yearly list of guidance documents and a list of new, revised and withdrawn guidances.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

 
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

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.

 
2014-07-01

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

 
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).

 
2014-06-25

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.

 
2014-06-17

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.

 
2014-06-11

From 15 to 21 May 2014 the following events took place in Rome (Italy): PIC/S Committee Meeting, PIC/S Executive Bureau Meeting and PIC/S Expert Circle on Active Pharmaceutical Ingredients (APIs).

 
2014-05-27

The FDA, in partnership with other federal and international agencies, took action last week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The Customs and Border Protection (CBP) also conducted extensive investigations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the USA, and found that most of the packages examined contained illegal prescription drugs that had been ordered from online sources.

 
2014-05-20

The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.

 
 
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