FDA - June 2009 Supplement Manufacturer Compliance

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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Extra Body Weight Might Be Protective

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A little extra weight may protect people from early death, reports this news release, Underweight and Extremely Obese Die Earlier than People of Normal Weight, Study Finds. According to the study results, "underweight people and those who are extremely obese die earlier than people of normal weight - but those who are overweight actually live longer than people of normal weight." I guess for me, that means I need to put on a couple more pounds. How about you? 

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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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IATA Perishable Cargo Regulations Take Effect

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Updated Jan 18, 2017:

The original post contains many invalid links.

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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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FDA Final Guidance On ICH Q10 - Quality Control System

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If you follow quality issues in the GMP regulated industry space, you'll want to get up to speed on ICH Q10. Here's what the FDA has to say about this new guidance, FDA - Q10 Pharmaceutical Quality System:

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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Marijuana Can Damage DNA and Cause Cancer

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Updated July 6, 2022

The original link broke.

You can still read about the same topic here:

Marijuana Damages DNA And May Cause Cancer, New Test Reveals - Science Daily

---  the original post follows below  ---

Sorry, here's the bad news according to this Medical New Today article, Marijuana Damages DNA And May Cause Cancer. In a nutshell, "In conclusion, these results provide evidence for the DNA damaging potential of cannabis [marijuana] smoke, implying that the consumption of cannabis cigarettes may be detrimental to human health with the possibility to initiate cancer development." 

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FDA Draft Guidance on Injectors

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To address the increasing popularity of drug-injector systems, the FDA (Food and Drug Administration) released a draft guidance, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. 

The draft guidance applies to, but is not limited to, jet, pen, needle-free, and mechanically operated injectors as well as piston syringes and injectors with computerized or electronic elements. Injectors are categorized into three groups: those intended for use with a wide range of currently marketed drugs or biological products, those intended for use with a specific class or product line, and those intended for use with a specific product. 

 The FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device intended for use with drugs and biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. 

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FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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Poor Oral and Periodontal Health a Risk For Erectile Dysfunction?!

An interesting read reported in this Medical News Today article, Erectile Dysfunction Might Be Associated With Chronic Periodontal Disease: Two Ends Of The Cardiovascular Spectrum. This is some early research suggesting that chronic periodontal disesase (CPD) might cause or be associated with erectile dysfuntion (ED) and/or coronary artery disease. In short, "CPD might be associated first with ED in young men and later with coronary artery disease in middle-aged men." It just might be time to recommit to better brushing, flossing, rinsing, etc. 

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Fewer FDA Inspectors - More Device Complaints

Here's an excellent graphic crafted by Dan Nguyen and Christina Jewett, Graphic: At FDA, Fewer Inspectors Trace More Device Complaints. It's easy to understand that from 1997 through 2007, two major trends have emerged: 1) adverse event reports have risen dramatically over the years, and 2) the number of FDA FTEs in the medical device field division have steadily declined. What you have to do, to shock some reality into yourself, is to view their graphic. Go see it. 

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FDA Website Redesigned

The FDA reports that "Through collaboration with users in testing site-wide designs, we made improvements to make FDA.gov easier and more satisfying to use." That may well be true as they describe their thinking on the redesign, About the FDA.gov Redesign - Why did FDA change its Website? Unfortunately, one unintended adverse effect impacts this blog. So, my apologies to folks who use and follow this blog . . . The FDA redesign has broken many links to FDA images, documents, and webpages. Here's to hoping they won't be redesigning the site again, any time soon. Peace.

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Global Drug Supply - Strategize Traceability Now!

I have to admit that I put on my California 'blinders' every now and then. This is one case where I got surprised to see what is going on in the global setting of drug traceability. I read this superb IndustryWeek article that frames, yet again, the pain induced when there is a general lack of harmonization, Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? Author Brian Daleiden taps into my Californa (CA) blindspot by stating, "California decided to go one step further and include an item-level drug serialization requirement in their state mandates. Given the significant incremental investment this would require, it was no surprise when the start date for CA compliance was pushed back to 2015, giving the industry a sigh of relief. But should it? A closer look at the current domestic landscape should give pause to anyone feeling too comfortable." In a nutshell, the article's conclusion challenges us to think about whether companies are making the right decisions, "The myriad of business and regulatory issues confronting most companies along the global pharmaceutical supply chain can be daunting. Against such uncertainty, it is understandable that the temptation is to take the path of least resistance and isolate and tackle each issue as it comes. Unfortunately, it is becoming clearly apparent that the industry has reached a tipping point where this approach will no longer work. The operational costs and business risks are just too high." Global Drug Traceability Mandates: Why Act Now? - Should pharmaceutical companies sit back and wait for someone else to blaze the drug traceability trail? (displayed on one page) 

Related Posts: FDA Draft Guidance - Drug Supply Chain and SNIs FDA - Global Drug Supply Chain Needs Better Oversight CA Gov Delays e-Pedigree Mandate to 2015 CA E-Pedigree - Pedigree and Serialization FDA Draft Guidance On Good Importer Practices 

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The HappyHour Gene - Implications for drinkers

This is an interesting read. University of California, San Francisco scientists have discovered the 'HappyHour' gene, a newly identified gene that makes fruit flies sensitive to booze. This means that drugs that mimic the effects of the gene may offer a new treatment against alcohol abuse. In this NewScientist article, 'Happyhour' gene may help put boozers off their drink, folks say, "People who are very sensitive to alcohol tend to drink less – that's the person who gets drunk on one glass of wine," and "The person who can drink everybody under the table – that's the person who is more likely to become an alcoholic." "Theoretically, a medication that increases the sensitivity to alcohol – that you need to drink less of to get an effect – might be protective," Heberlein says. Read Heberlein's findings in, Cell (DOI: 10.1016/j.ajhg.2009.04.018) - or the Research Abstract. 

Related Posts: Deadly Drinking In College - Drinking Games - Alcohol Deaths 21st Birthday - Extreme Drinking Binges - 12 drink avg for men 

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FDA Posts Current Flu Info and Resources

The FDA is doing its best to provide current information and resources about the 2009 H1N1 (Swine) Flu Virus. The following are 2 of their information-packed and massive link collections to find just about anything you can think of related to the swine flu. FDA - 2009 H1N1 (Swine) Flu Virus FDA - Influenza (Flu) Antiviral Drugs and Related Information 

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FDA Audit Preparation - Audit Theory - Be Ready

This Pharma Compliance Blog post, The Role of Affect in your Culture of Compliance, resonates with me. I think in principle, the core idea about being prepared for audits, extends well beyond GMP regulated industries. The takeaway for me is, of course your paperwork needs to be in order, AND your people have to prepped from an emotional and behavioral standpoint.

Related Posts:
21 CFR Part 820 QSR Audit Checklist - Are you ready?
Free 21 CFR Part 820 QSR Audit Checklist

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This class prepares plant personnel to participate in an FDA Inspection.

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FDA - Preparation Tips For Meetings With The FDA

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If you have upcoming meetings with the FDA, or are looking for ways to be more effective during the meeting, then this slide deck is a must read, Strategies to Prepare for Meetings with the FDA by Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA (circa 2006). In summary, she highlights these 3 things:

• Meetings Are a Critical Component of the Way We (Industry and FDA) Do Business
• Extensive Framework Around Meeting Process and Procedures Enhance Predictability
• Efficient Use of Meetings Facilitates Our Shared Public Health Goal

Related Posts: FDA Guidance - FDA and Sponsor-Applicant Meetings

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