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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FDA Dietary Supplement Guidance for Small Businesses

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The FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law:

FDA: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

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The Health, Drug, Prescription, and GMP Supersite Gift Store

Pharma Jargon Buster

Here's a nifty reference to add to your bookmarked favorites relating to pharma, biopharm, medical device, dietary supplements, and more.

NSF-DBA's Jargon Buster, lists abbreviations and acronyms, with their associated meanings.

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Parents - Are Your Kids Using Drugs?

Image via WikipediaParents and adult caregivers, if you're not sure, there's a website that can provide you with the tools needed to raise drug-free kids:

Partnership for Drug-Free Kids - Where families find answers

There's a tremendous wealth of information offered by the site.

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SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

2011 Predictions - Congress and FDA-Regulated Industries

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Find out the answer on FDA Matters: The Grossman FDA Report (TM) - - - Will the New Congress Be Good for FDA-Regulated Industries?

Wishing you all the best in 2011!

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