Certificates of analysis
Safety data sheets
Environmental, Health & Safety Risk Mitigation FDA Online USP Online
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
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.
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.
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
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
Avantor® is a global manufacturer and
distributor of high-quality products, services and solutions to professionals
in the life sciences and advanced technology industries. As our channel brand,
VWR offers an integrated, seamless purchasing experience that is optimized for
the way our customers do business. Operating from over 30 countries worldwide,
the company seeks to enable customer success in the biopharmaceutical,
pharmaceutical, medical device, diagnostics, healthcare, educational,
industrial, government, aerospace & defense, and semiconductor industries.