FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
Title:
FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf
Content:
This guidance describes FDAs thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).