Navigation Links
Global, common approach to pharmaceutical supply chain integrity the focus of workshop
Date:4/17/2012

Rockville, Md., April 17, 2012 The increasing globalization of the drug supply presents a host of public health challenges: theft and diversion of medicines, growth of illegal Internet pharmacies and insertion of adulterated medicines or ingredients into the supply chain. As pharmaceutical companies, regulatory authorities, lawmakers, healthcare practitioners and others continue to determine the best approaches to securing increasingly complex supply chains and protecting patients from potentially dangerous products, the U.S. Pharmacopeial Convention (USP) is convening a Supply Chain Integrity Workshop, May 22-23 in Rockville, Md., to consider key issues and solicit feedback on its newly proposed informational standard.

"The issues surrounding pharmaceutical supply chain integrity are not theoretical. On the contrary, they are very real, as evidenced by the discovery of counterfeit Avastin in various U.S. medical clinics in February and April," said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. "Legislative proposals circulating in Congress, continuing debate over product- versus lot-level tracking, gray markets growing in the face of drug shortages and other circumstances are converging, making it clear that the status quo is no longer adequate. Through this workshop, we hope to bring the different and sometimes disparate stakeholders together to find some common ground in addressing these difficult topics and to help determine a path forward on an overall approach to supply chain integrity."

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain. As current approaches vary based on individual companies, and present guidelines consider specific aspects of this issue but not supply chain integrity as a whole, USP is encouraging comprehensive public standards through its proposed informational standard contained in the draft General Chapter <1083> Good Distribution PracticesSupply Chain Integrity. The proposed general chapter will be part of the United States PharmacopeiaNational Formulary (USPNF), which contains quality specifications for medicines and their ingredients in the United States (these standards also are widely used internationally). The proposed standard covers four areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drugs and medical devices, and diversion and theft. Based on feedback provided at the workshop and through other channels, USP will consider whether changes to its proposed standard are needed.

The keynote presenter at the workshop will be Ilisa B.G. Bernstein, Pharm.D., J.D., director (acting), Office of Compliance, Center for Drug Evaluation and Research, FDA. Broad areas to be addressed at the workshop will include Supply Chain Members: Role, Responsibilities and Risks; Industry Perspective on Safeguarding the U.S. Drug Supply; and USP: Role, Processes and General Chapters.

Specific sessions and topics will include:

  • Regulations and Guidance Impacting the Supply ChainRepresentatives from North America (California State Board of Pharmacy, FDA and Health Canada), South America (Brazil, Argentina), Europe (European Directorate for the Quality of Medicines, World Health Organization, United Kingdom MHRA and Turkish Ministry of Health) and Africa (Nigeria National Agency for Food and Drug Administration and Control) will present regulatory supply chain approaches from around the world.

  • Regulatory Issues and StandardsTopics will include an FDA update on standardizing numerical identification for prescription drug packages, FDA unique device identification and GS1Global Standards (both unique identification numbers and track and trace standards).

  • Technologies and EnablersDifferent presentations on track and trace, including global efforts and industry's response, pilot studies and best practices will be featured.

Other presentations will consider tamper-evident packaging and impact and implementation issues related to new technologies from the perspectives of wholesalers, pharmacies and pharmacists.


'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

Related medicine news :

1. Negative attitudes toward fat bodies going global, study finds
2. Super Fitness Bikini Model Mega-Mogul Jennifer Nicole Lee Goes Global, British TV Appearance, QVC London May 12th Sharing Top Fitness Products
3. Off-Label Drug Use Appears Common
4. Common Plastics Chemical Might Boost Diabetes Risk
5. Test links strains of common parasite to severe illness in US newborns
6. Common Blood Pressure Drug Safe for Heart Failure: Study
7. Overuse Injuries Common Among Female College Athletes
8. Long-term neuropsychological impairment is common in acute lung injury survivors
9. Recovery from propofol anesthesia may be sped by use of common stimulant
10. Texting in College Classrooms Common, Distracting
11. Dating Violence Common by 7th Grade: Survey
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... , ... January 20, 2017 , ... Michael and Betsy ... Farber Cancer Institute. For Betsy, the clinical trial has been life-saving as she ... not worsened. , Betsy Brauser was diagnosed with ovarian cancer in 2009. She ...
(Date:1/20/2017)... ... ... “Mary Magdalene: Grace is Greater than Sin”: a unique and memorable piece ... “Mary Magdalene: Grace is Greater than Sin” is the creation of published author, Brenda ... women who had little knowledge of the female characters portrayed in the Holy Bible. ...
(Date:1/20/2017)... ... , ... “I Forgive You”: a fine examination of how God handles sin, including how ... published author, Stephen Miller, who, for over ten long years has been waiting to release ... Trinidad and Tobago, he has been serving the Lord for over twenty years, and he ...
(Date:1/20/2017)... ... ... enchanting tale that teaches children the true meaning of Christmas. “Journey to Christmas” is the ... devoted woman of faith. , “Becoming a parent changes you. In my case, the ... years, but actually doing it might have been a while in coming if it hadn’t ...
(Date:1/20/2017)... ... 2017 , ... “God's Miracle Man: Against All Odds”: an inspiring affirmation ... author, Keith C. A. Tucker, son of Minister Delores Pinnock and a Jamaican native ... Mark Hardy , “While sitting up in bed, I felt a pounding headache. It ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... , January 20, 2017 Stock-Callers.com today ... SGYP ), Novo Nordisk A/S (NYSE: ... and Pernix Therapeutics Holdings Inc. (NASDAQ: PTX ). ... Thursday, January 19 th , 2017, finishing near its session ... Index dropped over 0.7%, while shares of health care companies ...
(Date:1/20/2017)... LONDON , January 20, 2017 Avillion ... the appointment of Mark Weinberg , MD MBA as Chief ... , USA . ... Dr Weinberg has spent more than 17 ... "top 20" pharma companies to micro-cap biotech. Over the course of ...
(Date:1/19/2017)... -- The U.S. Food and Drug Administration today approved Trulance ... adult patients. "No one medication works for ... Beitz , M.D., director of the Office of Drug Evaluation ... "With the availability of new therapies, patients and their doctors ... ...
Breaking Medicine Technology: