21 CFR Part 820 QSR Audit Checklist - Are you ready?

Updated June 3, 2020

The original post didn't age well.

You might also be interested in this 21 CFR 820 Audit Checklist found on SCRIBD:
https://www.scribd.com/doc/162185575/122763962-Audit-Checklist-9001-13485-21-cfr-820

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If you're not quite ready, or are in the process of putting together your own internal audit checklist, it's a good idea to get ideas from others. Get a feel for checklist content, organization, and layout. Look at this excerpted portion of a checklist from Jack Kanholm's book (ISO 13485 and FDA QSR Internal Audit Checklist): ISO 13485:2003 Internal Audit Checklist - Demo Download.

Related Posts:
Free 21 CFR Part 820 QSR Audit Checklist

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You Eat Too Much Salt!!!!

People, stop eating so much salt, says this CDC post, "Americans Consume Too Much Salt - Lower sodium recommendation applies to almost 70 percent of American adults." Here's what you need to know . . . This study is the first to use national data to show that 69.2 percent of the adult population belongs to a specific group that should aim to consume no more than 1,500 mg of sodium per day. This group includes persons with high blood pressure, blacks, or middle-aged and older adults (more than 40 years old). The 2005 Dietary Guidelines for Americans recommend that adults in general should consume less than 2,300 mg (approximately one teaspoon of salt) of sodium per day. Can you cut back on your salt?! 

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Drug Identity Resources - ID Numbers

Updated February 23, 2021

There can never be too many resources available to help identify drug, pill, or medication identity by using various descriptors such as ID numbers and more. Here's a bunch for your use and reference . . .

Free Online Drug Identity Resources:

Drugs.com Pill Identification Wizard

RXList Advanced Search

 

Free Governmental Medication Resources:

Drugs@FDA

National Drug Code Directory

Electronic Orange Book 

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FDA Must Consider Dropping Age Limit For Morning After Pill

The FDA let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication. The judge ruled the agency had improperly bowed to political pressure from the Bush Administration when it set 18 as the age limit in 2006. U.S. District Judge Edward R. Korman in New York instructed the agency to make Plan B available to 17-year-olds within 30 days and to review whether to make the emergency contraceptive available to all ages without a doctor's order, reports this Washington Post news article, "FDA Ordered to Rethink Age Restriction for Plan B - Judge Says Politics Influenced Policy on the Contraceptive." What a polarizing firestorm this is going to create! What do you think?! 

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Chronic Pain - Vital Role of Vitamin D (video)

Updated September 9, 2020

The links in the original post broke.

You might also be interested in this updated link:

Mayo Clinic study suggests those who have chronic pain may need to assess vitamin D status

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Mayo Clinic research shows a correlation between inadequate vitamin D levels and the amount of narcotic medication taken by patients who have chronic pain. This study found that patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication -- nearly twice as much -- as those who had adequate levels. Similarly, these patients self-reported worse physical functioning and worse overall health perception. "This is an important finding as we continue to investigate the causes of chronic pain," says Michael Turner, M.D., a physical medicine and rehabilitation physician at Mayo Clinic and lead author of the study.

Watch this short video of Dr. Turner as he describes his findings about vitamin D and chronic pain. Tip: you might need to scroll down the page to the video.

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Up To Moderate Drinking And Socializing Good For You

It turns out that light-to-moderate drinking enhanced with socializing has been linked to a lesser risk of ischemic stroke and coronary heart disease, reports this EurekaAlert news article, "Light to moderate drinking and socialization are jointly good for cardiovascular health." Here's the bottomline . . .

• While heavy drinking is associated with a greater risk of stroke, light-to-moderate drinking has been linked to a lesser risk of ischemic stroke and coronary heart disease.
• New findings show that social support may enhance the beneficial effects of light-to-moderate alcohol consumption on risk of cardiovascular disease.

Cheers to good friends and safe drinking!

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Integrating Human Factors Engineering Into Medical Devices (video)

Checkout this free video, Integrating Human Factors Engineering Into Medical Devices. Human factors is the science and the methods used to make devices easier and safer to use. The FDA has a patient safety mission of distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. The FDA works with manufacturers to help ensure the application of Human Factors engineering to the design of new products. It also helps device users through identification and investigation of use-related errors. This is a nice primer and video lesson on all things about human factors.

   

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FDA Collaborates On Nanotech Initiative

The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology. I'm glad to see this. Until nanotechnologies are better and more deeply understood, it makes sense to me that the best minds thinking about nanotech are collaborating. More FDA Information: FDA and Eight Academic and Research Institutions to Collaborate Under Nanotechnology Initiative - Overarching goal: developing an efficient pathway for safe and effective nanoengineered medical products 

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NIH NIAAA Wants Re-Thinking Drinking (video)

Take some advice from these testimonials:

• "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
• "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
• "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Learn more about the NIH & NIAAA's new initiative to help rethink drinking, "Rethinking Drinking - Alcohol and your health. The website is pretty robust and easy to use.

• Download the free brochure: Rethinking Drinking - Alcohol and your health (pdf)
• The site features interactive tools, such as calculators for measuring alcohol calories and drink sizes. NIAAA is part of the National Institutes of Health. "About 3 in 10 U.S. adults drink at levels that elevate their risk for alcoholism, liver disease, and a diverse array of other physical, mental health, and social problems. Yet, many people give little thought to their drinking habits and the attendant risks" notes NIH Acting Director Raynard S. Kington, M.D. "These new materials remind all of us to think about how alcohol may be affecting our health"

If you don't have time to check out the website, listen to this ABC News video to learn more, "Do you drink too much? A new government initiative to help you rethink your drinking" (video)"

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FDA Warns - Avoid Burning - MRI and Drug Patch Interaction

Updated November 22, 2022

The original links broke.

You can still read about the same topic here:

• FDA advisory: Transdermal drug patches with metallic backings may cause burns during MRI - Healio
• What Patients Should Know Before Having an MRI Exam - FDA.gov

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If you wear drug patches, watch out! You don't want to get burned. If you wear them into an MRI machine, the patch could burn you, warns the FDA in their alert, FDA Warns About Risk of Wearing Medicated Patches During MRIs.

FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

• Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)
• Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.
• Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.

Additional Info by the FDA & others: FDA Public Health Advisory Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Transdermal Drug Patches with Metallic Backings Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009 

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FDA Says - Unwise To Ignore Form 483

I've taken for granted that no one would intentionally want to ignore an FDA Form 483. But just in case you thought about it, you'll want to reconsider. Read this Outsourcing-Pharma post, "Ignore a form 483? Not wise say FDA." Bottomline, doing nothing increases the likelihood of receiving a warning letter. In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”. 

Related Posts: Medical Device Sponsors - FDA Trends and Tips To Avoid 483s More FDA 483 Resources - Comments and Pearls from Validation Online FDA 483 Inspectional Observations - learn from these examples 

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FDA - Focus On Opioid Manufacturer REMS FDAAA

Updated September 15, 2016

The original post didn't age well (broken links).

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Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids (FDA.gov)

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If you're involved in or follow opioid manufacturing, you'll want to follow the FDA's focus on manufacturers of certain opioid drug products. FDA indicates that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioid drugs include brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA has authority to require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) when necessary to ensure that the benefits of a drug outweigh the risks. You can expect to hear more about this over the next several months from the FDA.

More FDA Information About This Topic:
Transcript for FDA's Media Briefing on the Safe Use of Opioids
February 9, 2009 [pdf 52 KF] Audio [5.09 MB MP3]
FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs

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FDA Advice About Pet Turtles And Salmonella Risk

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Updated December 5, 2021

The original link broke.

You can still read about the same topic here:

Pet Turtles: Cute But Commonly Contaminated with Salmonella - FDA.gov

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Turtles may look like cute pets, but it is estimated that they are responsible for over 70,000 cases of Salmonella infections every year in this country. Some of these infections can be serious or even fatal. In one case, a four week-old infant died of a Salmonella infection that was traced to a pet turtle in the home. In another case, two teenage girls became very ill after they swam in an unchlorinated family pool where pet turtles had been allowed to swim. Read or watch the FDA information about this, FDA report on Potentially Fatal Salmonella Infections from Pet Turtles. Personally, I had trouble viewing the video. But even with that, the text information is still valuable. 

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Primer On Clinical Drug Studies (video)

Watch this free video and learn about, "Drug Studies: Who, What, When, Where, and Why."  

UCTV says, "Almost every American takes a drug every day; many take three or more. This series presented by the UCSF Osher Lifelong Learning Institute explores your medicine, your health and your money. In this episode join John Flaherty, director of medical affairs at Gilead Science, Inc, as he explores the use of drug studies. Series: "UCSF Mini Medical School for the Public" [9/2007] [Health and Medicine] [Show ID: 13072] " 

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FDA Orange Book Online - Brand New Edition

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Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

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You've been waiting for this. A brand new 29th edition, the 2009 FDA Orange Book Online. The products in this FDA Orange Book have been approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This volume, the 29th edition, is current through December 31, 2008.

According to the FDA, "This publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal® Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act."

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FDA Quality by Design - QbD - Executive Guide (pdf)

Updated 6/25/2015:

The original post contains broken links.

You might also be interested in:  Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications by Mr. UMESH PATIL

===== original post follows =====

According to Cerulean Associates' Why Quality by Design? - An Executive's Guide to the FDA's Quality by Design (pdf), "Quality by Design is one of the most misunderstood and misused tools available to biopharmaceutical and medical device executives." The guide is easily understood and closes by driving to a 7-step QbD start-up plan. According to the guide, "the best way to assess how to implement QbD in your organization without making the same mistakes that other companies have made is to utilize a simple 7 step process."

Here's to hoping you enjoy and find this guide a good read, as I found it.

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#FDA #GMP #training #cGMP

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