Industry news

FDA draft guidance on CMO

The FDA has issued a draft guidance ‘Contract Manufacturing Arrangements for Drugs: Quality Agreements’. The guidance represents FDA’s current thinking and applies to human and veterinary drugs, certain combination products, biological/biotech products, finished products, APIs (or their intermediates) and drug constituents of combo drug/device products.

The guide defines the ‘who’ and ‘what’ of contract manufacturing and emphasizes that both the manufacturer and the owner (the party that introduces or causes the introduction of a drug into interstate commerce whether or not such drug is covered by a marketing application/license) have obligations to ensure cGMP compliance.

The guidance brings together key elements from ICH Q7, Q9 and Q10 and explains FDA’s expectations for contract manufacturers to implement quality management practices. The guide recommends that owners and contracted facilities establish a written quality agreement that covers the purpose/scope, terms, dispute resolution, responsibilities and change control.

The guidance also incorporates new requirements from FDASIA; both owners and contracted facilities are responsible for ensuring their products are not adulterated or misbranded – which now includes a revised definition of cGMP “implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in the drug manufacturing and finished drug products (which includes excipients)” as well as indicating who is responsible for setting specifications for raw materials; auditing, qualifying and monitoring suppliers as well as conducting required sampling and testing.