18 Sep 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Avantor Performance Materials, biomedical solution provider, 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, 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 Mr 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 Mr Siberski.