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  • Supply Chain Security - Producing the Order

    Supply Chain Security - Producing the Order

    At Avantor™ Performance Materials, supply chain security means focusing on how we can ensure product quality and product safety at every point in the manufacturing and delivery process.

    Our goal: Provide our customers transparency into Avantor's product supply chain, and align with our suppliers to identify, mitigate and manage risk throughout each step of the pharmaceutical ingredient supply chain.

    Producing the Order for Avantor Product

    Regulatory Support

    Avantor is committed to providing its customers the proper documentation and support regarding regulatory filing requirements for their pharmaceutical manufacturing operations. Avantor shares full regulatory data regarding its pharmaceutical production chemicals- information that helps customers file drug applications with global regulatory authorities.

    For products listed as "Highly Regulated" in Avantor's Management of Change program, we can also support the generation of a Drug Master File, containing the chemistry, manufacturing and controls of a drug component and supporting the quality, safety and efficacy of the drug manufacturer's final finished product. Avantor also provides Regulator Support Files for drug applications that use our excipient products.

    Full cGMP Capability

    Avantor's strategy for serving its pharmaceutical customers starts with full cGMP capability, and four of our global production locations operate under cGMP conditions in accordance with ICH Q7. These locations-in the US, the Netherlands and India-are registered with the US FDA, while the facility in India is also certified by Indian regulators. These registrations signify that the facilities are operated under the same regulatory requirements as those of our pharmaceutical manufacturer customers.

    Detailed Certificate of Analysis (CofA) 

    Certificates of Analysis are the fundamental building block of the relationship between Avantor and our customers. The more detailed the CofA, the greater value it has for those using our products in their pharmaceutical space. The Avantor CofA documents our quality control testing for each lot supplied to our customers. The CofA also provides source manufacturer batch tracking information for raw materials, which can save customers valuable product validation time.  CofAs for all Avantor products are available 24/7 here

    Management of Change (MOC) Program

    Avantor is recognized for its industry-leading change management and notification efforts. We provide customers change information for cGMP products in classifications ranging from Highly Regulated (HR), to Regulated (R), to Regulated Limited (RL), per IPEC guidelines, and we require advance notice of change from our suppliers as well. Learn more about our MOC program or download our MOC brochure

    Download a PDF of the Avantor Supply Chain Security - Producing the Order for Avantor Product flyer