Quality Agreement SOP
Transcription
Quality Agreement SOP
QUALITY AGREEMENTS: REGULATORY CONSIDERATIONS ǩ COMPLIMENTARY CONTENT Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation Contains: Quality Agreements: Regulatory Considerations For Development and Implementation © COPYRIGHT 2009 ENKAP 14 8 0 R OYA L PA L M B E A C H B LV D, S U I T E A ǩ R OYA L PA L M B E A C H , F L 3 3 411 8 7 7. 8 2 3 . 4 GX P (4 49 7 ) ǩ5 61.7 9 5 . 2 7 8 5 (O U T S I D E T H E U. S . ) ǩ w w w. e n K a p .c o m This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connection with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction. enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek the services of a competent attorney or other professional. enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying, altering, adding to or deleting portions of any product initially provided by enKap, Inc. Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the document’s accuracy, correctness, and compliance are solely yours. If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connection with defense of same. © copyright 2009 enKap Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation Table of Contents 1.0 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2.0 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3.0 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4.0 Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 5.0 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 6.0 History of Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 7.0 Attachments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 8.0 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 www.enKap.com Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation STANDARD OPERATING PROCEDURE Title: Quality Agreements: Regulatory Considerations For Development and Implementation SOP #: 300-003 Process Owner: Effective Date: Review Date: Designation: Name, Title Date Originator Name, Title Date Unit Head Approval Name, Title Date Quality Assurance Approval www.enKap.com 1 Standard Operating Procedure enKap Quality Agreements: Regulatory Considerations For Development and Implementation Standard Operating Procedure Quality Agreements SOP No: 300-003 Page 2 of 5 Date: 1.0 Purpose To provide standards for content and process used in the development and approval of a Quality Agreement with Contract Manufacturing Organizations. 2.0 Scope This procedure applies to Good Manufacturing Practice (GMP) operational departments and to the Quality Assurance department. 3.0 Key Terms TERM DEFINITION CMO Contract Manufacturing Organization. GMP Good Manufacturing Practice. Quality Agreement A formal quality assurance approved document that outlines the quality roles and responsibilities between contracting company and its approved CMO or CRO for a GXP operational activity. Vendor (Supplier) A firm or person engaged in providing development or commercially oriented products or services to contracting company. Vendor (Supplier) Assessment A planned and systematic evaluation to determine the acceptability and suitability of a potential or current vendor. 4.0 Responsibilities ROLE RESPONSIBILITY GMP Operational Department Assist in development, review and approve the Quality Agreement. Quality Assurance Department Issue the draft quality agreement to the operational and legal department for comment and contractual alignment, and provide final approval of the quality agreement. Legal Department Review the draft quality agreement for comment and contractual alignment. Effective Date: ___________________ 2 www.enKap.com Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation SOP No: 300-003 Page 3 of 5 Date: Standard Operating Procedure enKap Quality Agreements 5.0 Procedure PROCEDURE ACTION 5.1 DEVELOPMENT OF QUALITY AGREEMENT RESPONSIBILITY Using the Quality Agreement template (refer to attachments 1 and 2), design the Quality Agreement to include, but not limited to, the following subjects: • Responsibility of the Quality Agreement • Provision for Amendment Requirements of the Quality Agreement • Definition of the Service Being Provided by the CMO and/or Vendor (Supplier) • Information Sharing Requirements • Right to Audit • Notification of Regulatory Agency Inspections • Applicable Safety Requirements • Service or Supply Requirements 5.1.1 • Testing and Release Requirements • Quality Roles Between Contracting Company and its Approved CMO Quality Operational Groups GMP Operational Department and Quality Assurance Department • Notification of Change • Notification of Recall/Product Retrieval • Notification of Deviations and Related Investigations to Procedures • System and/or Equipment Qualification and Validation Requirements • Storage and Control Documents • Storage and Shipping of Product • Revision Log • Approvals • Deliverable Acceptance/Rejection Criteria Effective Date: ___________________ www.enKap.com 3 Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation SOP No: 300-003 Page 4 of 5 Date: Standard Operating Procedure enKap Quality Agreements PROCEDURE ACTION 5.2 DETERMINATION OF NEED FOR QUALITY AGREEMENT RESPONSIBILITY The need for a Quality Agreement with a vendor or supplier will be determined by, but not limited to, the following criteria: 5.2.1 GMP Operational Department and Quality Assurance Department • Results of vendor or supplier assessment • Criticality of vendor or supplier to operational requirements • Clinical development phase • Commercial production use 5.3 REVIEW OF QUALITY AGREEMENT 5.3.1 Conduct a review of the Quality Agreement for potential liability and business contract conflict. Legal Department 5.3.2 Conduct a review of the Quality Agreement to ensure all required sections are included that pertain to the actual services being provided by the CMO. GMP Operational Department 5.4 APPROVAL AND ISSUANCE 5.4.1 After completion and final review of the Quality Agreement, the responsible GMP operational department initiating the service with the CMO or vendor, Quality Assurance Department representatives, and the CMO and/or vendor quality and management personnel approve the agreement by signature and date. The Quality Agreement may be a standalone document or incorporated into the business agreement. GMP Operational Department and Quality Assurance Department 5.4.2 After approval, provide a control copy of the signed quality agreement to the CMO and/or vendor. Quality Assurance Department Effective Date: ___________________ 4 www.enKap.com Standard Operating Procedure Quality Agreements: Regulatory Considerations For Development and Implementation SOP No: 300-003 Page 5 of 5 Date: Standard Operating Procedure enKap Quality Agreements PROCEDURE ACTION RESPONSIBILITY 5.5 TRAINING 5.5.1 Applicable GMP Operational department personnel are required to review the approved Quality Agreement, as required, in order to become familiar with the relevant sections of the agreement, and the roles and responsibilities that have been agreed to between the company and its approved CMO and/or vendor. 5.6 MAINTENANCE 5.6.1 As required, the approved Quality Agreement is amended to document changes in the roles and responsibilities between the company and its approved CMO and/or vendor. Designated Personnel GMP Operational Department and Quality Assurance Department 6.0 History of Change SOP / REVISION NO. DESCRIPTION OF SOP/REVISION DATE 400-001 Quality Agreements New 7.0 Attachments Attachment 1: Active Pharmaceutical Product Quality Agreement Template (Example) 8.0 References Reference 1: 21 CFR 211.22(a) To link to the references listed above, as well as additional references, please visit our website: www.enKap.com Effective Date: ___________________ www.enKap.com 5 Now that you have reviewed the Quality Agreement SOP, enKap is proud to present the Quality Agreement Integrated Training and Auditing Information Package INSTRUCTIONAL GUIDE: QUALITY AGREEMENTS: REGULATORY CONSIDERATIONS FOR DEVELOPMENT AND IMPLEMENTATION This instructional guide explains what a quality agreement is, presents the regulatory basis for quality agreements discusses design characteristics and enforcement strategies. ACTIVE PHARMACEUTICAL INGREDIENT (API) PRODUCT QUALITY AGREEMENT TEMPLATE-EXAMPLE This template example joint agreement covers the essential quality attributes pertinent to the manufacture of drug substance, describes the roles and responsibilities and the defined process of communication between the Contracting Company and Contract Manufacturing Organization (CMO) company. QUALITY AGREEMENT SOP This SOP provides standards for content and process used in the development and approval of a Quality Agreement with Contract Manufacturing Organizations (CMO). QUALITY AGREEMENT POWERPOINT TRAINING SLIDES AND TRAINER INSTRUCTIONAL NOTES Excellent training material that can be customized to your individual company’s information needs. PRE-ORDER TODAY FOR ONLY $299 ORDER FORM ON NEXT PAGE ORDER FORM Quality Agreement Integrated Training and Auditing Information Package Pre-order only $299.00 ORDERING IS SIMPLE 1. Online: www.enKap.com 2. 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