Quality_Agreements_Contract_Manufacturing_Operations_11-03-2016_Katz_S508.pdf - Putting the Quality in Quality Agreements for Contract Manufacturing

Quality_Agreements_Contract_Manufacturing_Operations_11-03-2016_Katz_S508.pdf

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Putting the ‘Quality’ in Quality Agreements for Contract Manufacturing OperationsPaula KatzManufacturing Quality and Guidance Policy Staff DirectorOffice of Manufacturing QualityCDER Office of ComplianceNov. 3, 2016Parenteral Drug Association Outsourcing/CMO ConferenceWashington, DC The views expressed are those of the presenter and do not necessarily represent those of the FDA or United States government.
22What we’ll coverBackgroundWhy Outsource?Legal FrameworkDraft Guidance on Quality Agreements in Contract ManufacturingScope and purposeDefinitionsHighlights and ExpectationsEnforcement Perspectives and Outcomes
33ContextContract manufacturing as a subset of “outsourcing”Manufacturing services vs. purchase of goods, raw materials, components (upstream); distribution services (downstream of finished goods)Similar concepts and principles
44Why outsource? Owners want…Faster, better, strongerNiche expertiseIncreased capacityResource shiftingShorter time to marketTemporary solution
55Outsourcing: Contracted facilities provideUnit Ops: micronizing, sterilizing, etc.Analytical testing, control labsPackaging, labelingOthers
66Legal Framework: FD&C Act501(a)(2)(B): A drug is adulterated if:the methods used in, or facilities or controls used for, manufacturing, processing, packing, or holding do not conform with CGMP.FDASIA § 711: CGMP includes:the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products.This explicitly links CGMP to quality management activities.
77Legal Framework: Relevant Regs (I)21 CFR 210.1: Failure to comply with CGMP renders the drug adulterated and subject to regulatory action.21 CFR 210.2(b): If you only contract for some operations, those operations must comply with applicable CGMP.You can’t “contract around” CGMP!21 CFR 210.3(12): Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.
88Legal Framework: Relevant Regs (II)The CGMP regs don’t explicitly require a written quality agreement, but…21 CFR 211.22(a): QU is responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.21 CFR 211.22(d): QU procedures and responsibilities must be in writing.21 CFR 200.10: Contract manufacturers are an extension of the manufacturer’s own facility.
99Previous FDA Guidance:Quality AgreementsFDA GFI, Quality Systems Approach to Pharmaceutical CGMP (2006):“Outsourcing involves hiring a second party under a contract to perform the operational processes that are part of a manufacturer’s inherent responsibilities…Quality systems call for contracts (quality agreements) that clearly describe…”Materials, servicesSpecification-setting responsibilities

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