Oct 21 2013
Avantor™ Performance Materials has expanded its global pharmaceutical offering with Macron Fine Chemicals™ brand materials produced under a new “Regulated Limited” (RL) classification of pharmaceutical chemicals.
The RL classification, part of Avantor’s Management of Change (MOC) program, provides customers with full traceability of ingredients in products not manufactured under current Good Manufacturing Practices (cGMP) standards. Macron Fine Chemicals™ materials classified as RL are produced at Avantor’s manufacturing facilities in Poland, The Netherlands and the United States.
As part of its commitment to supply chain security, Avantor requires suppliers who provide ingredients for RL-classified materials to follow the company’s MOC guidelines and agree to technical review visits.
“The addition of RL-classified products to our portfolio, supported by our global manufacturing capability and ability to provide transparency in sourcing and using raw materials, means Avantor can meet a wider range of customer needs around the world,” said Paul Smaltz, Executive Vice President, Pharmaceuticals and The Americas at Avantor.
Avantor, a global manufacturer and supplier of high-performance chemistries, established its MOC system in 2004 to keep pharmaceutical 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.
Earlier this year Avantor enhanced its program by adding the new RL classification to cover products for which a true regulated classification does not exist.
The MOC program’s classification structure, including the new RL designation, is explained in a brochure entitled “Meeting Change with Confidence,” available for download from the Quality Systems and Supply Chain section on Avantor’s website. Information on the Macron Fine Chemicals™ RL-classified products can be found in the Pharmaceuticals-Product Profile section of the Technical Library on the website.
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.