Supply Chain Programme Now Offers Non-cGMP Ingredients Traceability

Avantor Performance Materials has enhanced its Management of Change (MOC) supply chain alert programme with a new classification to meet the needs of customers wanting full traceability on ingredients not produced under 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 programme, 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 programme 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 programme 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."

“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 maximise safety and ensure consistent quality and reproducible process results."

The company’s MOC programme 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.

Avantor Performance Materials, Inc., +1 610 573 2600, info@avantormaterials.com, www.avantormaterials.com.