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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... locations throughout Arkansas that offers insurance and financial preparation services, is providing an ... Rock City Rescue organization. , Rock City Rescue is a locally recognized nonprofit ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International ... promote standards of excellence for the field of eating disorders, announces the opening ... 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out ... free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting ... children of all ages; it is a non-competitive, non-timed event, which is all about ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
Breaking Medicine News(10 mins):
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017  PMD ... OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... strategic hub service that expedites and streamlines patient and ... Spiro PD 2.0, and wellness management services.  ... medical device used to measure lung function for a ...
(Date:9/13/2017)... OrthoAtlanta has been named the official orthopedic and sports ... the 2018 College Football Playoff (CFP) National Championship to be ... Atlanta, Georgia . OrthoAtlanta is proud to ... in many activities leading up to, and including the national ... OrthoAtlanta ...
(Date:9/12/2017)... -- Consumer reviews on the independent review site Consumer Affairs ... for hearing aids, ranking it higher than Miracle Ear ™, ... ... Hearing Aids ... store that provides high performance, state-of-the-art, German-engineered hearing aids directly to ...
Breaking Medicine Technology: