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:12/4/2019)... ... ... While the holidays are a time for joy and sharing, they can ... Service specialists. , “There are many behavioral and logistical changes you ... Joyce Cavanagh, AgriLife Extension specialist in family economics, College Station. , Prioritize and plan ...
(Date:12/4/2019)... ... December 04, 2019 , ... Eolas Therapeutics Inc. ... tobacco use and dependence. The study will investigate safety and pharmacokinetics (PK) of ... of orexin-1 (hypocretin-1) receptors that is being developed in collaboration with AstraZeneca. , ...
(Date:12/2/2019)... ... December 02, 2019 , ... ... worked with EMD Serono, the North American branch of the healthcare business of ... site is designed to educate and inform patients, caregivers, the public, patient advocacy ...
(Date:12/2/2019)... ... December 02, 2019 , ... The Sterling P1000 washer-disinfector ... Processing Department. The elegant design provides a smooth polycarbonate surface that is as ... that allow for manual loading that provides high flexibility and uses very little ...
(Date:11/30/2019)... (PRWEB) , ... November 28, 2019 , ... ... company known for its award-winning cannabis cultivation, production and dispensary operations, has received ... Chocolates™ line of products. , “This is a great accomplishment for our company ...
Breaking Medicine News(10 mins):
(Date:12/5/2019)... (PRWEB) , ... December 05, ... ... announce its entrance into the Amazon Web Services (AWS) Public Sector Partner ... , The Public Sector Partner program recognizes and collaborates with partners that ...
(Date:12/4/2019)... ... December 04, 2019 , ... Tenex Health, Inc., ... technologies to treat chronic pain in soft and hard tissue, recently achieved a ... , Dr. Bernard Morrey, Chief Medical Officer of Tenex Health, said, ...
(Date:12/2/2019)... (PRWEB) , ... December 02, 2019 , ... Data integration ... companies having access to several internal and external data sources, staff are still working ... A typical trial feasibility analysis can take six weeks or more, and nearly one-third ...
Breaking Medicine Technology: