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)
Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store
Wednesday, March 13, 2013
New EU GDP Guidelines Published
Wednesday, August 24, 2011
GMP Proper Documentation Tips - Free
Updated 10/19/2015:
The post below is outdated. You might be interested in cGMP training by SkillsPlus Intl Inc.
===========
I found this helpful document, it's free, Documentation - Rules for Completion (GMP Trainers' Survival Kit II) - PDF
It could be especially useful for classroom trainers, or for staff trying to reinforce GMP good documentation practices.
Return Home: http://drughealth.blogspot.com/
The Health, Drug, Prescription, and GMP Supersite Gift Store
Friday, January 23, 2009
HIV Pre Exposure Prophylaxis - Very Sharp Two Edged Sword
Pre-exposure prophylaxis (PrEP) against HIV infection just got a huge spotlight, in this ABC News article, ABC News Examines Pre-Exposure Prophylaxis For HIV Prevention. It seems that HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection. Part of the debate is whether approval of such pills could lead some high-risk groups to forgo safe sex practices such as condom use.
After reading this, I'm wondering if we should all be worried about prEP usage without safe sex practices. Are you worried?
Related Posts:
Abzymes Pinpoint The HIV Achilles Heel
109 HIV Drugs And Vaccines Under Development
HHS Updates HIV Treatment Guidelines (free pdf)
HIV Hope and Breakthrough - Abzymes Attack HIV Achilles Heel (video)
Return Home: http://drughealth.blogspot.com/
Return to Mobile Home: http://drughealth.mofuse.mobi/
Wednesday, January 14, 2009
FDA Draft Guidance On Good Importer Practices
The guidance is designed to anticipate potential sources of product hazards and offer preventive controls that firms can implement to mitigate such hazards and help ensure imported products are safe and compliant with regulations. The draft is organized under 4 guiding principles . . .
- Establishing a product safety management program
- Knowing the product and applicable U.S. requirements
- Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle
- Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements
The draft guidance also recommends that:
- importers consider instituting practices to identify and minimize risks associated with imported products
- in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors
- importers understand the products that they import and the vulnerabilities associated with these products
- importers understand the hazards that may arise during the product life cycle, including all stages of production, and ensure proper control and monitoring of these hazards
The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.
Related Posts: FDA Struggles To Keep Products From Foreign Sources Safe FDA Finds It Hard To Inspect Foreign Drug Manufacturing Plants
Return Home: http://drughealth.blogspot.com/
Posts
