Adds extra notification level to industry leading initiative for customers who need traceability even for non-cGMP manufactured ingredients
Center Valley, PA (USA) – September 17, 2013 – Avantor™ Performance Materials has enhanced its Management of Change (MOC) supply chain alert program with a new classification to meet the needs of customers who want full traceability on ingredients that are not produced under current Good Manufacturing Practices (cGMP) standards.
Avantor’s comprehensive Management of Change system keeps customers fully informed about changes in the company’s product supply chain.Avantor, a global manufacturer and supplier of high-performance chemistries, established its MOC system in 2004 to keep pharmaceutical manufacturing customers completely informed about changes in the company’s product supply chain, including changes to raw materials, processes, or manufacturing sites. Under the program, customers are notified depending on the significance of the change that occurs and the classification of the material, in accordance with the appropriate International Pharmaceutical Excipient Council (IPEC) guidelines.
Until recently, products and materials in Avantor’s MOC program were classified among four tiers: Highly Regulated (“HR”); Regulated (“R”); Non-Regulated with limited change information (“NI”); and basic Non-Regulated (“N”).
The company enhanced the program by adding a new fifth classification to cover products for which a true regulated grade does not exist, according to Richard Siberski, Avantor Global Director of Quality.
“We created an additional ‘Regulated Limited’ RL classification at the request of customers, who need to ensure full traceability even for ingredients that are not produced under cGMP conditions,” he said. “Suppliers who provide us with ingredients for RL-classified materials must follow Avantor MOC guidelines and have agreed to verification and site visitations,” he said.
“Avantor’s best-in-class MOC system is part of our overall supply chain and quality assurance initiative that gives pharmaceutical customers the benefits of shared information to help maximize safety and ensure consistent quality and reproducible process results,” said Siberski.
The company’s MOC program and the additional RL classification are explained in a new brochure entitled “Meeting Change with Confidence,” available for download from the Quality Systems and Supply Chain section on the Avantor website at www.avantormaterials.com.
Visit www.avantormaterials.com or www.twitter.com/avantor_news for more information.
About Avantor™ Performance Materials Based in Center Valley, PA (USA), Avantor Performance Materials manufactures and markets high-performance chemistries and materials around the world under several respected brand names, including the J.T.Baker®, Macron Fine Chemicals™, Rankem™, BeneSphera™, and POCH™ brands.
Avantor products are used in a wide range of industries. Our biomedical and life science solutions are used in pharmaceutical production, laboratory research for academic, industry and quality control, and in medical lab testing. Our electronics materials products are used in the manufacturing of semiconductors. For additional information please visit www.avantormaterials.com or follow www.twitter.com/avantor_news.
Media Contacts:
Allison Hosak
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Avantor Performance Materials, Inc.
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Cell: 908-329-7281
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Bob Martin
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Avantor Performance Materials, Inc.
Office: 610-573-2683
Cell: 908-329-4869
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