Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality Agreements, Draft Guidance, May 2013
FDA Guidance Delineates responsibilities between CMO and client for API, finished drug product, combination products and biologicals 3
FDA Guidance Does not apply to Type A medicated articles and medicated feeds, medical devices, dietary supplements, and human tissue intended for transplantation.
FDA Guidance Applies to commercial manufacturing. Manufacturing includes processing, packing, holding, labeling, testing, and operations of the quality unit.
Definitions Owner = contract giver or client Contracted Facility = contract acceptor or contractor
Responsibilities Owner is responsible for assuring product introduced into interstate commerce is not adulterated or misbranded. Responsible for final product release. (can t be delegated!) See also 211.22(a) Contract Facility is responsible for compliance to cgmps.
Pop Quiz Does this mean that the contracted facility is not responsible for adulteration or misbranding?
Answer No, because the contractor is considered an extension of the owner. Both owner and contractor are responsible.
21 CFR Part 211.22(d) States that the responsibilities of the quality unit must be in writing
21 CFR Part 820.50 Purchasing Controls - each manufacturer shall establish and maintain quality requirements that must be met by supplier, contractors, and consultants.
ICH Guidance Q7A GMPs for API s Section XVI: Contract Manufacturers: there should be a written and approved contract or formal agreement between a company and its contractor that defines in details the responsibilities, including the quality measures, of each party. 12
EU Guidelines for GMPs Volume 4 Chapter 7: Outsourced Activities section 7.1 states there shall be a written contract covering the outsourced activities...
Pharmaceutical Inspection Convention Scheme (PIC/S) PE 009-11 (Part I) Guide on GMPs for Medicinal Products, March 2014 Chapter 7: Contract Manufacture and Analysis states there must be a written contract between the contract giver and the contract acceptor which clearly establishes the duties of each party.
International Pharmaceutical Excipients Council (IPEC) IPEC Guide for Quality Agreements, 2009 establishes best practices for Quality Agreements
ICH Q9 Risk Management recommends evaluation of suppliers and CMOs through audits and Quality Agreements.
Pop Quiz Are Quality Agreements subject to FDA review?
Quality Agreement Scope Terms (including effective date) Dispute resolution Change control Responsibilities and contacts
Quality Agreement Deviations Audits by owner and regulatory agencies Preventing cross-contamination Facilities and equipment validation
Quality Agreement Material management sampling, testing, quarantine, release, specifications, auditing & qualifying suppliers, storage, labeling Product specifications, release, expiration dating, batch numbering, storage, shipment
Quality Agreement Laboratory Controls procedures for sampling and testing, method validation, equipment maintenance and calibration, stability, and reserve samples OOS investigations.
Quality Agreement Record retention Field alerts and recalls Complaints and adverse event reporting Subcontractors Man-in-the-plant
Quality Agreement Owner Responsibility transfer of knowledge to review and approve SOPs, MBRs, specifications, lab records, validation documents(not all cases), annual reports, investigations, and change controls(not all cases).
Pop Quiz If a MBR approved by the owner contains a step that is non-gmp compliant, is the contractor responsible?
Answer Both owner and contractor are responsible.
Gospel According to Luke GMP Training Bi-lingual documents
Sample QAA
Thank You! You ve been a wonderful audience! Luke.foo@sppirx.com