Q7 Q&As - Quality Guidelines : ICH

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Q7 Q&As - Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Follow this link to the Q7 section: Q7 Q&As - Quality Guidelines : ICH:

"Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs."

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Sex Supplements - Containing Viagra; Other Issues

Sex supplements often contain Viagra ingredients | Reuters:

"Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.

Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."

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The Exemptee Institute
The Designated Representative Institute

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More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

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Watch Out For CEP Problems in 2011

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The European Directorate for the Quality of Medicines and Healthcare (EDQM) suspended or withdrew 19 certificates for active pharmaceutical ingredients in the latter half of 2010 because their manufacturers failed or refused inspections*. These are the main points:

1. Virtually all of the suppliers included in the list was from Asia.
2. The EDQM awards a CEP if the company declares GMP compliance (without a pre-approval inspection).
3. The EDQM conducts periodic inspections of API manufacturers, however, the EDQM has inspection capacity constraints and can only inspect about 30 sites a year.

This is important to follow, as you can expect the huge number of API suppliers to continue to come from that part of the world,

Acronyms:
-  Certificates of Suitability (CEPs)
-  Active pharmaceutical ingredient (API)

* EDQM suspends, withdraws 19 API certificates in 2H10 - Securing Industry

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Rx-360 Consortium Pilots Audit Sharing

From the Rx-360 An International Pharmaceutical Supply Chain Consortium:

"Rx-360 is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers. The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization with the mission to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain."

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FDA On Drug Counterfeiting

In this American Society of Health-System Pharmacists (ASHP) article, Drug Counterfeiting Burden Remains a Guess, Experts Say, the Director of Pharmacy Affairs in FDA's Office of the Commissioner says, "We have no idea what the prevalence of counterfeiting is in the United States." Here's what I get out of this article, counterfeiters have been assisted by the globalization of the pharmaceutical industry and a shift to making both active pharmaceutical ingredients (APIs) and finished products outside of the developed world. 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight Gambling With Life - Counterfeit Drugs - Like ED Drugs (Viagra) Counterfeiters Can Get Life In Jail 

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