New EU GDP Guidelines Published

Quality and integrity of medicinal products are key factors that must be maintained during the entire supply chain from the manufacturer to the patient. The European Commission revised the guidelines that lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.

Wholesale distribution of medicinal products is defined as "all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned."

The revised EU GDPs, Good Distribution Practices, become effective September 8, 2013.
Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

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Dietary Supplement Industry - Vulnerable to FDA Enforcement

Dietary Supplement Industry: Everyone Vulnerable to FDA Enforcement:

"Who is at risk in the dietary supplement industry from the enforcement arm of FDA?

The short answer, says veteran attorney Anthony Young, is everybody.

"We are no longer an unregulated industry in any way," declares Young, a partner with Kleinfeld, Kaplan and Becker, a firm concentrating on the regulation of products subject to FDA jurisdiction."

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FDA Asking for More Control Over Drug Compounding

F.D.A. Asking for More Control Over Drug Compounding - NYTimes.com:

"Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice [GMP], which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen federal standards for nontraditional compounding,” Dr. Hamburg stated in the written testimony. “Such legislation should appropriately balance legitimate compounding that meets a genuine medical need with the reality that compounded drugs pose greater risks than those that are evaluated by F.D.A.”"

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Related articles

• Compounding pharmacies need FDA oversight (drughealth.blogspot.com)

P.R. China - Good Manufacturing Practice for Drugs (2010 Revision) - In English - Free

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Updated March 24, 2020

The link in the original post broke.

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Chinese and English Translation GMPs - 
SFDA Good Manufacturing Practice for Drugs (2010 Revision) ( MOH Decree No. 79 )

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The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.

The document has 43 pages and is divided into 14 chapters with 313 paragraphs.

The link below takes you to the free English language version of the doucment.

State Food and Drug Administration, P.R.China (SFDA) - Ministry of Health (MOH) Decree No. 79 - Good Manufacturing Practice for Drugs (2010 Revision):

"Article 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, are enacted to regulate the manufacturing and quality management of Drugs."

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Related articles

• FDA Compliance & Enforcement - Inspection of Cosmetics: An Overview (drughealth.blogspot.com)
• FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers (drughealth.blogspot.com)

FDA Consumer Updates - Food Safety Tips for Healthy Holidays

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FDA Consumer Updates; Food Safety Tips for Healthy Holidays:

"Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill.

Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed.

The symptoms usually are not long-lasting in healthy people—a few hours or a few days—and usually go away without medical treatment. But foodborne illness can be severe and even life-threatening to anyone, especially those most at risk:
- older adults
- infants and young children
- pregnant women
- people with HIV/AIDS, cancer, or any condition that weakens their immune system
- people who take medicines that suppress the immune system; for example, some medicines for rheumatoid arthritis

Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home."

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FDA Issues Dietary Supplement Warning Letter

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Updated August 15, 2016

You might also be interested in this FDA guidance document:
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry - Draft Guidance (PDF)

- -  original post follows below  - -

Here we go folks. It appears we're going to start seeing action by the FDA in the Dietary Supplements sector.

This FDA Law Blog post reports the issuance of an FDA warning letter, FDA Posts its First Dietary Supplement GMP Warning Letter.  A nice read.

If you want to see what else is going on, go to the FDA's Electronic Reading Room - Warning Letters - Browse Warning Letters By Subject - the letter D - scroll down to the Dietary Supplement selections.

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Avoid The DOJ - FCPA Violations - Foreign Corrupt Practices Act

I never heard about the FCPA (Foreign Corrupt Practices Act) until reading about it today. Wikipedia says FCPA addresses accounting transparency requirements under the Securities Exchange Act of 1934 and another concerning bribery of foreign officials.

Anyways, FDANews reports that the Department of Justice’s (DOJ) FCPA and healthcare fraud units are beginning to work together to investigate FCPA violations in the device and pharmaceutical industries. The DOJ has more information about FCPA on their website.

Here's why you need to care. The DOJ wants to aggressively enforce and investigate violations of the FCPA, targeting pharmaceutical and medical device companies as well as their individual executives and board members; this leaves them open to potentially massive legal and financial liabilities.

Additional Resources:
Bribery Abroad: Lessons from the Foreign Corrupt Practices Act

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FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy! Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf). 

Bottomline...

1. Clean
2. Separate
3. Cook
4. Chill

Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips 

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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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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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Free FDA Good Laboratory Practice Tutorial - GLP

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Updated November 23, 2020

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TITLE 21--FOOD AND DRUGS - CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES - SUBCHAPTER A - GENERAL -  

PART 58 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES - FDA.gov

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Free FDA GLP Tutorial

Check out this fantastic free tutorial by the folks at LabCompliance, "Good Laboratory Practice Regulations." It's a great introduction and primer on the FDA's GLPs (Good Laboratory Practice).

At the time of this post, the tutorial is free. Be forewarned that the vendor initially makes their tutorials accessible to all visitors of LabCompliance at no charge. However over time they are moved to the Usersclub section and hence accessible to Club Members. I'm telling you this just in case you're reading this post and discover that the tutorial is no longer freely accessible.

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