CAPA Basics - Carl Anderson and Barbara Immel

I always enjoy running across well-written GXP articles.  Kudos to Carl for posting this informative CAPA Basics article by Barbara Immel on his blog (GXP Perspectives), CAPA Basics- Corrective And Preventative Action.

I've been following Barbara Immel's writing for some time, and always pick up several pearls of wisdom from her.

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Human Errors: Overcoming the Challenges - a training class by SkillsPlus International Inc.

Learn to overcome human errors as a root cause to deviations, when human error is the wrong diagnosis.

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Biosimilars In Recently Passed Healthcare Bill

I was really surprised to find out that biosimilars are included in the recently passed healthcare bill, Patient Protection and Affordable Care Act.  I learned about this while reading Kevin O'Donnell's post on his blog (Where cooler heads prevail), "New U.S. Healthcare Bill Includes Pathway for Biosimilars and 12 Year Patent Exclusivity."

Kevin writes:

"This provision, Title VII- Providing Access to Innovative Medical Therapies, "prohibits the approval of an application as either biosimilar or interchangeable until 12 years from the date on which the reference product is first approved. In addition, it stipulates an additional 6 months of exclusivity for the use of reference products "in the pediatric population.""

References:
Full text of the Patient Protection and Affordable Care Act HR 3590

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FDA Controversy - Regen Biologic's Menaflex Device

The FDA is reassessing the safety of a device (Regen Biologic's Menaflex Device) that it previously approved for patients. The FDA conducted a March 23, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting. Although the panel expressed that they would have liked to have seen more data on the device, they largely backed it as a safe and effective therapy.

The larger looming issue now is whether this will become precendent setting and raise the prospect of FDA re-evaluating previously approved devices.

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FDA Webinar on FDA Inspection Process

When:     Thursday, March 25, 2010, at 2 p.m. ET

Where:    https://collaboration.fda.gov/inspectionprocess/

Host:       FDA’s Office of Regulatory Affairs (ORA), 301-827-3101

             ORAContactUs@FDA.HHS.GOV

Speaker: Michael C. Rogers, deputy director, Office of Regional Operations

To ensure the safety of marketed products, FDA experts inspect domestic and foreign establishments, check shipments of imported products, and collect and test product samples for signs of contamination.

During this webinar, FDA experts will present information on

• the organization within FDA that is charged with conducting inspections
• the facilities FDA is responsible for inspecting
• what an inspection involves
• inspection follow-up and enforcement actions
• the rigorous training that inspectors receive

The presentation will run approximately 30 minutes and will include an opportunity to ask questions.

To join the webinar:

1. Click https://collaboration.fda.gov/inspectionprocess/ (or cut and paste it into your Internet browser)
2. Click "Enter as a Guest," fill in your name, then click "Enter Room"
3. Dial 1-877-685-5350 and enter participant passcode: 969082

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

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

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New - FDA Orange Book - February 2010 Supplement (PDF)

It's here! The February 2010 supplement of the FDA's Orange Book, APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS - 30th EDITION - Cumulative Supplement 02 - February 2010 (pdf).

Updated 2/6/2012:  Here's the location of the latest version of the Orange Book:  http://www.accessdata.fda.gov/scripts/cder/ob/eclink.cfm

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FDA Restricts Cigarette and Tobacco Sales and Distribution

I don't smoke, so I'm happy to see this action coming from the FDA, FDA Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco. The new rule becomes effective June 22, 2010, and has the force and effect of law.

Here are the highlights:

New Requirements Relating to Sale and Distribution

• Prohibits the sale of cigarettes or smokeless tobacco to people younger than 18.
• Prohibits the sale of cigarette packages with fewer than 20 cigarettes.
• Prohibits the sale of cigarettes and smokeless tobacco in vending machines, self-service displays, or other impersonal modes of sales, except in very limited situations.
• Prohibits free samples of cigarettes and limits distribution of smokeless tobacco products.

New Requirements Relating to Marketing (Labeling, Advertising, and Promotion)

• Prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events.
• Prohibits gifts or other items in exchange for buying cigarettes or smokeless tobacco products.
• Requires that audio ads use only words with no music or sound effects.
• Prohibits the sale or distribution of items, such as hats and tee shirts, with tobacco brands or logos.

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FDA Warns Daylight Savings Might Create Problems For Medical Devices

When I went to work yesterday, under Daylight Savings Time, my meeting times for recurring meeting times in a popular web meeting software application were inconsistently wrong. Now apply the time change problem to medical devices.

The FDA advises in, Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way:

"If you have any medical equipment that uses, creates or records time information about your diagnosis or treatment and the manufacturer has not updated it, the equipment may not work properly when Daylight Saving Time (DST) starts and ends."

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Dietary Supplements - Tips for FDA Inspection

If you're involved in the manufacturing of dietary supplements, you might find this article by Amy Caplette a helpful read, Inside a GMP Inspection.  She recounts her inspection experience and provides some tangible tips that you can follow before you get inspected.

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Rx-360 Consortium Pilots Audit Sharing

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The Rx-360 Consortium announced the start of a pilot plan to allow pharmaceutical manufacturers to share audits of suppliers. The first part of the pilot is intended to gauge the value of sharing the existing body of supplier audit information that already exists within consortium member companies.  The consortium has an Audit Standards Working Group with 27 participants, representing 19 companies and organizations. The group is looking at standards for APIs, excipients, supply-chain security, basic chemicals, packaging, and print.

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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Drink 3 to 5 Glasses of Red Wine to Prevent Heart Attacks

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I was originally disappointed when I first scanned this Medical News Today article, Resveratrol May Replace Aspirin As Heart Protector; Longevinex® First Branded Resveratrol Pill Successfully Tested During Heart Attack.

As a red wine lover, my disappointment turned to joy when I read this:

The amount of resveratrol in 3 to 5 glasses of red wine is only about 3-5 milligrams, but the heart protective effect is believed to be produced by the total polyphenolic molecules in a glass of dark, aged red wine, ~60 milligrams per 5-ounce glass. The optimal health benefit derived from red wine is achieved at a consumption level of 3-5 glasses, which would be considerably more expensive than a resveratrol pill, and certainly pose the problem of inebriation.

In a nutshell, I get to drink red wine to, pardon the pun, to my heart's content!

For Wine Lovers:
Wine Lovers Dishwasher Magnet

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FDA GMP Top 20 Countdown - Better than Letterman

For the next several weeks, watch the Top 20 Count Down GMP Observations.  This series is hosted by SkillsPlus International Inc.  Just go to the SkillsPlus International Inc. home page and click on the "Top 20 Count Down GMP Observations" hyperlink (on the left navigation) for the weekly count down presentation.

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