John Klein serves as the chairman of Cambridge Therapeutics, a health care technology company in Teaneck, New Jersey. With experience that encompasses contract manufacturing for pharmaceutical products, John Klein has worked with Food and Drug Administration-approved contractors across the globe.
Owners of contracted facilities where pharmaceuticals are made are responsible for ensuring that approved products satisfy all requirements and that deficient products are rejected before release. Similar to a quality-control process, contract manufacturing necessitates executive verification that all products are produced, packaged, and distributed in compliance with FDA regulations. In addition, the quality unit that checks the products for compliance must have its procedures and professional obligations clearly articulated in writing.
Known as quality agreements, these documents outline the products to be produced and their quality specifications, as well as the communication process between the owner and the contract facility. Comprehensive quality agreements also should cover subcontractor responsibilities, the process for making changes to processes or equipment, and guidelines for audit practices.
Owners of contracted facilities where pharmaceuticals are made are responsible for ensuring that approved products satisfy all requirements and that deficient products are rejected before release. Similar to a quality-control process, contract manufacturing necessitates executive verification that all products are produced, packaged, and distributed in compliance with FDA regulations. In addition, the quality unit that checks the products for compliance must have its procedures and professional obligations clearly articulated in writing.
Known as quality agreements, these documents outline the products to be produced and their quality specifications, as well as the communication process between the owner and the contract facility. Comprehensive quality agreements also should cover subcontractor responsibilities, the process for making changes to processes or equipment, and guidelines for audit practices.
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