Regulatory library

FDA guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements

FDA's guidance on quality agreements between owners and contract manufacturers. It asks that the agreement say who qualifies, maintains and changes equipment, since both parties stay responsible for CGMP.

ValDoc's library holds 1 provision of FDA guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements. This page is guidance in our words. The regulation's own text governs.

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Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. FDA guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements, whole document

    Effective NOV2016

    Contract Manufacturing Arrangements for Drugs: Quality Agreements

    Open the FDA site

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See your own equipment in ValDoc.

Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.