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Defines framework conditions and processes between contract givers and contract acceptors in order to meet mandatory quality criteria.

 

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News about GMP/cGMP

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.

 
 
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