Monday, September 27, 2010

Johnson and Johnson GMP Headache - Insights

This investigative report by Mina Kimes offers insights into Johnson and Johnson's quality control breakdowns, Why J&J's headache won't go away. This appears to be the same article published in Fortune magazine's September 6, 2010 issue.

QCU written procedures, lab controls top 483 citations in FY 2009.: An article from: Validation Times
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Tuesday, September 21, 2010

Mesothelioma Awareness Day 2010

Malignant Mesothelioma, coronal CT scan. Legen...Image via Wikipedia
Mesothelioma Awareness Day is September 26th, according to the Mesothelioma Applied Research Foundation.

All supporters, volunteers and patients affected by the asbestos-related cancer mesothelioma will help recognize Mesothelioma Awareness Day this Sunday on September 26, 2010. To learn more about this awareness day, go to the Foundation's webpage, Mesothelioma Awareness Day.


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Monday, September 20, 2010

FDA Guidance - Impact Resistant Lenses - Q and A

Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. As you read through the guidance, you'll find quite a number of useful hyperlinks to additional information and references.

Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410. This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing.

This guidance is a revision of “Impact-Resistant Lenses: Questions and Answers (FDA 87-4002),” issued September 1987. This guidance updates answers to questions that industry and consumers frequently ask FDA about impact-resistant lenses and FDA regulation of eyewear. The revision reflects the exemption of sunglasses from the Premarket Notification (510(k)) requirement effective February 19, 1998 (21 CFR 886.5850(b)). The revised document also includes a more detailed discussion about lens blanks, semi-finished, finished, and plano lenses, as well as import procedures. The terms "eyeglasses" and "spectacles" are used interchangeably in this document.

Eyewear products regulated by FDA are commonplace in the daily lives of the vast majority of the general public. FDA believes that impact-resistant lenses are an essential component of the safe design of these devices.  The use of impact-resistant lenses in eyeglasses and sunglasses is addressed in 21 CFR 801.410.

For more information on this topic, contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) by phone at 1-800-638-2041, by fax at 301-847-8149, by e-mail at dsmica@fda.hhs.gov, or write to the following address:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International, and Consumer Assistance
10903 New Hampshire Ave.
WO66-4613
Silver Spring, Maryland 20993

#FDA #GMP #training #cGMP

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Monday, September 13, 2010

Electronic Orange Book Online

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

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

The FDA offers an electronic (online) version of the Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations.

Here are the important links to the electronic Orange Book:

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Orange Book: Search by Active Ingredient
Orange Book: Search by Proprietary Name
Orange Book: Publications - PDF versions of the annual edition and cumulative supplements

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Monday, September 6, 2010

FDA Form 483 Search Tool

FDAzilla offers a specialized search tool that makes it possible to search for Form 483 observations issued by the FDA.

One possible use of the search tool is to get a listing of Form 483s issued to companies in a particular country, for example, the search results of form 483 observations issued to companies in India.  Just alter your search keywords to view different results.

Related reading:  Compliance Remediation for Pharmaceutical Manufacturing: A Project Management Guide for Re-establishing FDA Compliance

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.
An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.
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Saturday, September 4, 2010

FDA - Safe Drug Use After Natural Disasters

Floods, fires, earthquakes, hurricanes, oh my.  The FDA provides recommendations on Safe Drug Use After a Natural Disaster. Here's what they cover:

Drugs Exposed to Excessive Heat, such as Fire
Drugs Exposed to Unsafe Water
Drugs that Need Refrigeration

For more information:
FDA - Natural Disaster Response
FDA - Hurricanes: Health and Safety

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If you want to learn more:  Emergency Preparedness The Right Way

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