The federal government is taking a tiered approach to enforcement: companies with more than 500 employees were required to become GMP (good manufacturing practices) compliant by June 2008; companies with 21-499 employees must become compliant before June 2009; and companies with fewer than 20 employees will need to be compliant by 2010, according to this Lab Science News post, New FDA Regulations for Dietary Supplements.
Well, June 2009 is upon is. Lorraine Heller reports that with two weeks to go before mid-sized supplement firms need to comply with new GMPs, the US Food and Drug Administration (FDA) has said it aims to inspect 200 facilities this fiscal year, in her post, FDA aims for 200 GMP inspection this year.
Time is up, and here are some additional references:
FDA Issues Dietary Supplements Final Rule
FDA 21 CFR part 111
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Monday, June 29, 2009
FDA - June 2009 Supplement Manufacturer Compliance
Saturday, June 27, 2009
Extra Body Weight Might Be Protective
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Friday, June 26, 2009
NPR On FDA Tobacco Oversight (audio)
This audio news story, Talking Tobacco Companies Into FDA Oversight, fresh from NPR:
The Food and Drug Administration (FDA) will have regulatory authority over the $89 billion tobacco industry as soon as President Obama puts his signature to a bill passed by Congress. The change took decades to happen — the industry fought hard to keep the FDA out — but finally succumbed to changing social norms and the guidance from one in its own ranks. Guest host Alison Stewart speaks with Steve Parrish, a former Altria executive and who pushed the company to support FDA regulation of the tobacco industry, and Dr. David Kessler, who was head of the FDA in the mid-1990s.As a non-smoker, I'm thrilled to see this new day of FDA oversight. As a country we should be paying more attention to improving population health.
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Wednesday, June 24, 2009
IATA Perishable Cargo Regulations Take Effect
Image via WikipediaThe original post contains many invalid links.
You might still be interested in:
IATA Perishable Cargo Regulations
IATA Time & Temperature Sensitive Labels
= = original post follows below = =
Kevin O'Donnell reminds us that the new version of IATA's Perishable Cargo Regulations (PCR) take effect on July 1, 2009, in one of his recent Where Cooler Heads Prevails Blog (http://www.coolerheadsblog.com/) posts, Links to IATA's New Regulations for Time and Temperature-Sensitive Healthcare Products.
In one of his earlier posts, New IATA Regulations Take Effect July 1st, 2009, he writes, "The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009. Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitive Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation of a new handling label."
In a nutshell, the 9th edition of the PCR introduces new requirements for the transportation logistics of healthcare products. Amongst these are a new quality management system, training requirements and a new label (mandatory as of July 2010). These changes are the result of the collaboration by carriers with pharmaceutical associations and many other stakeholders in the supply chain, all within a major revision to Chapter 17.
Additional Resources and Materials:
The new IATA “Time and Temperature Sensitive” label and training requirements
The IATA Perishable Cargo Regulations manual
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Monday, June 22, 2009
FDA Final Guidance On ICH Q10 - Quality Control System
- FDA cGMP QSR GMP Online Training Courses - by SkillsPlus International Inc.
This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH "Q8 Pharmaceutical Development" and ICH "Q9 Quality Risk Management." ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional.In summary, the International Conference on Harmonization's (ICH) Q10 attempts to provide a comprehensive model for an effective quality management system by building upon good manufacturing practices (GMP).
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