Broomfield, CO (PRWEB) January 25, 2012

“manufacture of compounds of great power – Understanding and controlling the risks.” Webinar presented by Solutions Affygility premiere February 7, 2012 at 10 am MST

Affygility last seminar solutions, environment, health, safety, and toxicology professionals in solutions Affygility discuss key concepts, practices and trends for the handling of highly potent compounds or medicinal substances. “As the active pharmaceutical ingredients or drug substances of increasingly specific, or powerful, many of these compounds are included in any category control a band of 4 or 5,” said Dean M. Calhoun, CEO of Solutions Affygility. “Companies handling potent compounds category 4 or 5 must implement sophisticated engineering and administrative controls to prevent occupational exposure.”

For more information and instructions to register for this seminar on “Production of high potency compounds – Understand and control the risks.” page on the website solutions Affygility ‘

About

Affygility solutions

Affygility Solutions provides environmental health, industrial, occupational safety, occupational toxicology and services in biotechnology, pharmaceutical and medical devices. Our services include Affytrac: the major EHS software systems for the life sciences industry, online and offline training seminars, potent compound safety categorization, occupational exposure limits, toxicology services, the validation of containment and control of rent, and more. We have provided these services for small businesses, life-sized and big science in the United States, Europe and Asia.

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Rockville, Maryland (PRWEB) January 4, 2012

As the pharmaceutical industry continues to globalize, the challenges of securing the complex supply chains and protect patients from counterfeit medicines, as well as the consequences of failure in safety and proper handling, must be mounted. In an effort to encourage public policy integrated throughout the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of best practices to help ensure that medicines can be tracked to its original manufacturer, have not been adulterated or counterfeit, and are transported to their destination with its quality intact. USP is seeking general information on these recommendations in the integrity of the supply chain, which are published here.

Supply chain integrity is minimize the risks that arise anywhere along the supply chain, from research of pharmaceutical raw materials for its manufacturing and distribution. The proposed new rule is not mandatory, and is contained in the draft Integrity USP General Chapter correct distribution chain PracticesSupply. The proposal is intended to serve as a central guidance document outlines the essential elements of an effective strategy. While pharmaceutical companies have their own methods to address this issue, the size and sophistication of companies and their suppliers vary widely, as their quality systems and risk management methods. Broad consensus on issues such as tracking and tracing technology does not exist, and smaller companies that can be invoked for the supply of pharmaceutical ingredients may or may not be comparable security approaches its larger counterparts.

no incentive for all players in the pharmaceutical industrylarge and small companies, regulators and standard setting-bodiesto reach agreement on hot topics such as tracking and tracing technology, and broader level, to code that is robust and universal approach to the integrity of global supply chain, said Praveen Tyle, Ph.D., scientific director of the USP. USP has developed a proposal which we hope will evolve as the industry, the FDA and other weigh in. Our role as an independent body provides an opportunity to call on all parties and advance this fundamental question. While some sources of information available through the FDA guidelines, trade organizations and other sources, a comprehensive approach is lacking. USP can bring something more concrete than a technical report as part of a mechanism that can be periodically updated to better meet the needs of all.

proposed standard covers four main areas:

? ImportationDetails three main importers undertake initiatives to prevent and detect possible risks: Supply chain risk management, developing effective partnerships with suppliers and creating a supply chain quality system.
? Counterfeit medicines and medical DevicesDocuments types of counterfeit medicines, the medical consequences, and the distribution and extent of counterfeit medicines and devices.
? Best Practices for Combating Counterfeit Medicines and Medical DevicesCovers issues such as packaging technologies (tamper-proof designs, technologies, authentication and serialization), pedigree of drugs, carrying machine-readable data (2D barcodes and RFID tags), repackaging guidance, information retention and security, international standards and best practices in anti-counterfeiting.
? Fun and TheftAddresses factors that increase the risk of theft of pharmaceuticals, medical devices and drug components, security systems, devices and procedures to be applied to reduce the risk that critical information gathered after the discovery of a theft .

USP is a non-profit organization that develops public health standards for identity, strength, quality and purity of drugs and their ingredients, published in the United States PharmacopeiaNational Form (USPNF). Rules PSU officer named in sections of the adulteration and misbranding of the federal food and drug laws are legally required by the FDA, and are used worldwide in a variety of ways. In addition to including quality specifications of medicines and individual ingredients, USPNF chapters covering general or contain evidence or other information that apply to multiple drugs or ingredients (often applicable), or provide guidance on various topics affecting quality of medicines (for information). The latter are not legally binding, but is often used widely nationally and internationally.

provided will be useful to all organizations and individuals involved in the global supply chain, including manufacturers, transport companies involved in cars, trucks, rail services, air and sea, vendor logistics services, freight forwarders and consolidators, agents, importers and exporters, operations and presence reempaque, wholesalers and distributors, retailers, mail order, hospital, nursing home and other pharmacies, and mail clients including the Postal Service U.S. express delivery and other services. Chapter proposals is available on the website of USP. The formal proposal will be published in Pharmacopeial Forum 38 (2), MarchApril 2012. This is the vehicle (which is free and publicly available on the Internet) through which USP accepts public comments on its rules.

proposed general chapter and comments submitted to the USP is a central theme of a workshop integrity of the supply chain that the USP is the call May 22 to 23, 2012, in Rockville, Md. This will be a opportunity to provide information, including whether the information should be included in the chapter. More information about the workshop is available here.

USP advances in public health from 1820

The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization, standard-setting organization that advances public health through public standards and related programs that help ensure quality, safety and benefit of medicines and food. USP standards are sold and used worldwide.

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