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Note to the User of this Document


Please recognize that the goal of the Quality Agreement is for it to be a living docum...
Quality Agreement
                                   Between



                               Contract Lab
              ...
Contract Lab - CLIENT COMPANY Quality Agreement




                                   Table of Contents



Section       ...
Contract Lab - CLIENT COMPANY Quality Agreement




1.0   PURPOSE
      The purpose of this document is to establish a Qua...
Contract Lab - CLIENT COMPANY Quality Agreement



        contributing to additional environmental stress during the hand...
Contract Lab - CLIENT COMPANY Quality Agreement



                                Responsibilities                       ...
Contract Lab - CLIENT COMPANY Quality Agreement



                              Responsibilities                         ...
Contract Lab - CLIENT COMPANY Quality Agreement



                               Responsibilities                        ...
Contract Lab - CLIENT COMPANY Quality Agreement



                               Responsibilities                        ...
Contract Lab - CLIENT COMPANY Quality Agreement



                               Responsibilities                        ...
Contract Lab - CLIENT COMPANY Quality Agreement



                              Responsibilities                         ...
Contract Lab - CLIENT COMPANY Quality Agreement



                               Responsibilities                        ...
Contract Lab - CLIENT COMPANY Quality Agreement



                               Responsibilities                        ...
Contract Lab - CLIENT COMPANY Quality Agreement



                                Responsibilities                       ...
Contract Lab - CLIENT COMPANY Quality Agreement




20.0      COMMUNICATION CONTACTS




       Functional Area      Contr...
Contract Lab - CLIENT COMPANY Quality Agreement



                                         Attachment A
                 ...
Contract Lab - CLIENT COMPANY Quality Agreement



                                     Attachment B
                   Do...
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Analytical Quality Agreement Template

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Transcript of "Analytical Quality Agreement Template"

  1. 1. Note to the User of this Document Please recognize that the goal of the Quality Agreement is for it to be a living document that is used by both the client and the contracting organizations. Both organizations must determine the business practices that are applicable to their relationship, and ensure that those are included in the document with defined roles and responsibilities. This document is a template that should be used to get you started on your journey, not a check box exercise. A solid Quality Agreement is built with risk management practices employed. Each relationship should be assessed to determine the proper amount of oversight and involvement from the client organization. Please contact us at Xavier University’s Med-XU if you feel you would benefit from consultation to work with you through this process. We have a vairety of Quality Agreement templates for you to use for free based on the services you are involved in (finished product manufacturing, API manufacturing, packaging, etc.). Best regards, Marla A. Phillips, Ph.D. Director of Med-XU 513-745-3073 Phillipsm4@xavier.edu Page 1 of 17
  2. 2. Quality Agreement Between Contract Lab Street address City, State and Zip USA and Client Company Street address City, State and Zip USA Director, Quality Assurance Client Company Date Vice President Client Company Date Director, Quality Assurance Contract Lab Date President Contract Lab Date Page 2 of 17
  3. 3. Contract Lab - CLIENT COMPANY Quality Agreement Table of Contents Section Description Page Signature Page 1 1.0 Purpose 3 2.0 Scope 3 3.0 Policy Statements 3 4.0 Definitions 4 5.0 Regulatory Authorizations and Communications 4 6.0 Equipment and Testing Facilities 5 7.0 Documentation 6 8.0 Materials Receipt and Storage 7 9.0 Reference Standard Management 7 10.0 Analytical Methods and Testing 7 11.0 Deviations, Discrepancies, OOS, and Investigations 8 12.0 Change Control 9 13.0 Data Acceptance and Disposition 10 14.0 Sample and Record Retention 10 15.0 Complaints and Recalls 11 16.0 Inspections and Audits 12 17.0 Annual Product Review (commercial) 12 18.0 Subcontracting 13 19.0 Revision History 13 20.0 Communication Contacts 14 Attachment A: Events requiring Client Company notification 15 Attachment B: Documents requiring Client Company signature 16 Page 3 of 17
  4. 4. Contract Lab - CLIENT COMPANY Quality Agreement 1.0 PURPOSE The purpose of this document is to establish a Quality Agreement between the following two companies who both are organized and exist under the laws of the United States of America: Registered Office: Contract Lab Street address City, State and Zip and Registered Office: Client Company Inc. Street address City, State and Zip This Quality Agreement takes the form of a detailed checklist including the activities associated with pharmaceutical analytical testing, release, and stability program management of Client Company Product and Drug Substance. Responsibility for each activity is assigned to either Contract Lab and/or Client Company (hereinafter, Client Company) in the appropriate box in the Delegation Responsibility Checklist that follows. For each responsibility listed, the respective party is required to put into effect all applicable procedures and to take all necessary actions to effectuate that responsibility in accordance with cGMPs, ICH guidelines and all applicable laws. Nothing in this Quality Agreement shall affect in any way a party’s obligation to comply with cGMPs, ICH guidelines and all applicable laws. 2.0 SCOPE The scope of this agreement includes all activities related to the analytical methods development, quality control testing, stability program management, and stability testing required for innovator drug products, comparator drug products, and matching placebos. This agreement is effective upon final approval by the designated individuals from both Client Company and Contract Lab 3.0 POLICY STATEMENTS The companies will treat this Quality Agreement as a binding document. Any changes to this agreement shall require prior written approval from both parties. Contract Lab agrees that all activities related to the testing and release of Product(s) and Drug Substance will be conducted to the standards of cGMP (Code of Federal Regulations, 21 CFR §210 and §211), ICH guidelines, and according to guidelines outlined in this agreement. This agreement may be amended with the written approval of both parties. Both Contract Lab and Client Company are obligated to maintain, in confidence, the information received during the term of this agreement regarding activities, scope, and projects as well as products, tools, and production methods, beyond that which is publicly available. The details of this obligation may be further specified in a separate Non- Disclosure Agreement agreed to by Client Company and Contract Lab While on Contract Lab's premises, or interfacing with Contract Lab employees, Client Company representatives will honor and respect Contract Lab’s confidentiality agreements with their other clients. Contract Lab shall comply with all Federal, State, and local ordinances regarding hazardous waste and environmental effects as a result of their procedures. Contract Lab shall avoid Page 4 of 17
  5. 5. Contract Lab - CLIENT COMPANY Quality Agreement contributing to additional environmental stress during the handling and testing of the Product and Drug Substance. 4.0 DEFINITIONS cGMP: Current Good Manufacturing Practices and General Biologics Products Standards as promulgated under each of the following, as in effect on the date of this agreement, and as amended or revised after the date of this agreement, including: • the U.S. Food, Drug & Cosmetics Act as published in 21 CFR (Parts 210, 211) and other FDA regulations, policies or guidelines in effect at a particular time for the manufacture, testing and quality control of investigational or commercial drugs, and • any other non-U.S. jurisdiction's laws, regulations, policies, and guidelines applicable to the testing of pharmaceutical materials, as may be requested by Client Company, provided that Client Company provides Contract Lab with copies of all such applicable laws and regulations, and that Contract Lab agrees to comply with the added requirements. Such agreement shall not be unreasonably withheld by Contract Lab Drug Substance and/or API: Active Pharmaceutical Ingredient, and for the purpose of this agreement, shall mean any API being investigated by Client Company. Manufacture: All steps in the manufacture of Product or Drug Substance, including but not limited to filling, testing, labeling, packaging, and storage by the designated manufacturer. Product: For the purposes of this agreement, Product(s) shall mean, singularly or collectively, innovator drug products, over-encapsulated comparator drugs, and matching placebos. SOP: Standard Operating Procedure. Specifications: A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the test(s) described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. "Conformance to Specification" means that the material, when tested according to the listed analytical procedures, will meet the listed acceptance criteria as outlined in the IND/NDA. RESPONSIBILITY DELEGATION CHECKLIST Responsibilities Client Contract Company Lab 5.0 Regulatory Authorization and Communications 5.1 Will maintain all registrations, licenses and authorizations X as are required by applicable laws to operate cGMP pharmaceutical testing and stability program management sites for Product and Drug Substance. 5.2 Will act as liaison with FDA and other regulatory X authorities for the approval, maintenance and updating of specifications and C&M data in the IND/NDA. 5.3 Will provide Contract Lab with a copy of those portions of X the IND/NDA that are applicable to the testing and stability program management of Product and Drug Substance. 5.4 Will ensure that all specifications provided to Contract Lab X comply with the IND/NDA. 5.5 Will ensure that all testing is conducted versus the most X recent version of the specifications given to Contract Lab Page 5 of 17
  6. 6. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab by Client Company. 5.6 Will prepare and submit post-marketing annual reports to X the FDA or other regulatory authorities in accordance with applicable laws. 5.7 Will prepare and provide all C&M data relating to the X testing and stability program management of Product and Drug Substance as necessary for Client Company to perform its regulatory responsibilities. 5.8 Will make copies available, upon request, of any X X documentation necessary for either party to respond to inquiries by the FDA or other regulatory authorities relating to Product or Drug Substance. 6.0 Equipment and Testing Facilities 6.1 Will provide all required qualified testing facilities, trained X staff, and validated/qualified equipment necessary to perform the testing of Product or Drug Substance in accordance with the Specifications and instructions and in compliance with cGMP regulations, ICH guidelines and other applicable regulatory guidelines. 6.2 Will not perform any activities that may adversely affect X Product or Drug Substance. 6.3 Will make no changes to the facilities or procedures used X for the testing or stability program management of Product or Drug Substance, either directly or indirectly, without the written notification to Client Company. 6.4 Represents that the staff engaged in the testing and X stability program management of Product and Drug Substance has the education, training and experience, or any combination thereof, to enable those persons to perform their assigned functions. [Note: Training extends to the particular operations that the employee performs and to cGMPs as they relate to the employee’s functions]. 6.5 Maintains all training records in such a way that they are X readily available for the personnel working on Product and Drug Substance. 6.6 Ensures that all training relative to a specific task will be X completed prior to the initiation of the task, and that training will be conducted with sufficient frequency to assure familiarity with cGMP requirements applicable to the position and function. 6.7 Certifies that it will not use the services of any person or X organization debarred or suspended under 21 U.S.C. §335(a) or (b), nor will it use the services of any person who has been convicted of a felony under the laws of the United States relating to the regulation of any drug product under the Food, Drug and Cosmetic Act. 6.8 Shall have adequate written procedures for the prevention X of Product or Drug Substance contamination and cross- contamination. 6.9 The testing process and control procedures shall be X Page 6 of 17
  7. 7. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab validated and qualified by Contract Lab in the facility they intend to use for the testing of Product and Drug Substance. 7.0 Documentation 7.1 Controlled Documents 7.1.1 All documents used to control Product or Drug Substance X from the point of receiving Product or Drug Substance test samples to releasing Product or Drug Substance test data, are considered controlled documents. The following list of documents to be controlled by Contract Lab includes, but is not limited to: • Product and Drug Substance Specifications provided by Client Company • SOPs related to the testing of Product and Drug Substance, and stability program management • Analytical Test Methods used for release and stability testing of Product and Drug Substance • Method Transfer Protocols and Reports • Method Validation Protocols and Reports • Stability Protocols • Certificate(s) of Analysis • Certificate(s) of Compliance • OOS/OOT Investigations • Laboratory Notebooks 7.1.2 The documents outlined in Section 7.1.1 above are X controlled documents and shall be filed in such a manner as to be traceable. Current SOPs and test methods shall be readily accessible to QC chemists. 7.1.3 Shall have adequate SOPs for all cGMP operations X performed. 7.2 Preparation, Review and Approval of Controlled Documents 7.2.1 Client Company Quality Assurance will review and X approve all controlled documents related to Product and Drug Substance that are created by Contract Lab 7.2.2 Shall sign and submit the controlled documents approved X by Client Company to Contract Lab Inc.’s Document Control for issuance and security. 7.2.3 Testing records for Product and Drug Substance will be X reviewed and approved by Contract Lab Inc.’s Quality Assurance to determine completeness and compliance with all established, approved written procedures and specifications. Client Company representatives may review unapproved documents, if deemed appropriate. 7.3 Management of Controlled Documents Page 7 of 17
  8. 8. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 7.3.1 Ensures that changes are not made to controlled X documents in a manner inconsistent with the provisions in Section 12.0 of this document entitled “Change Control”. 7.3.2 Ensures that only valid/current versions of the controlled X documents are available for use. 7.3.3 Ensures that only valid/current versions of the controlled X documents are used. 7.3.4 Ensures that outdated / non-valid versions of documents X are archived according to documented procedures to prevent unintended use. 8.0 Materials Receipt and Storage 8.1 Shall ensure that a sufficient volume from each lot of X Product and Drug Substance is delivered to Contract Lab for testing. Additional samples may be taken and shipped, upon request from Contract Lab 8.2 Shall ensure that samples received contain labels with X accurate sample identification. 8.3 Shall store sufficient numbers of Product and Drug X Substance samples as necessary to perform the analytical and stability testing according to approved protocols. These samples shall be stored in a temperature/humidity controlled storage area. 8.4 Product and Drug Substance stability samples shall be X stored in appropriate stability chambers according to associated stability protocols. 9.0 Reference Standard Management 9.1 Will be responsible for retaining and managing all X necessary USP reference standards used for the testing of Product and Drug Substance. 9.2 Will be responsible for supplying enough Product and X Drug Substance to Contract Lab to be used as reference standard material. 9.3 Will be responsible for establishing the purity values of X Product-related reference standards. 9.4 Will be responsible for following approved procedures for X managing the retest date requirements for all USP and Product-related reference standards. 9.5 Will ensure that the most current reference standard X material is available for the QC chemists to use during analytical testing. 9.6 Will ensure that the most current purity value is available X as a controlled document for the QC chemists to use during analytical calculations. 10.0 Analytical Methods and Testing 10.1 Shall develop analytical methods for the testing of Product X and Drug Substance. 10.2 Shall write method validation protocols. X Page 8 of 17
  9. 9. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 10.3 Shall review and approve the method validation protocols. X X 10.4 Shall execute all validation-related activities for Product X and Drug Substance. 10.5 Shall notify Client Company via email or telephone within X 2 business days of identification of failures encountered during validation-related activities. These failures must be investigated and properly documented. 10.6 Shall create all validation summary reports related to X validation-related activities for Product and Drug Substance. 10.7 Shall approve all validation summary reports for Product X X and Drug Substance. 10.8 Will retain a copy of the approved protocol and final report X for all validation-related activities for Product and Drug Substance. 10.9 Shall write stability and release testing protocols. X 10.10 Shall perform stability studies and release testing, X according to the protocols provided by Client Company, in order to support all regulatory submissions. 10.11 Shall provide stability summary reports to Client Company X of data for all stability testing conducted on Product and Drug Substance. 11.0 Deviations, Discrepancies, OOS, and Investigations 11.1 Planned Deviations 11.1.1 Shall follow Contract Lab Inc.’s change control procedure X to address all planned deviations as a revision of the approved test methods. 11.1.2 Shall sign and approve the change control documentation X X addressing planned deviations, prior to implementation. Consent by a facsimile message is also adequate. 11.2 Unplanned Deviations, Discrepancies, and OOS Results 11.2.1 Contract Lab will communicate to Client Company Quality X Assurance via telephone or by email (as a second choice) any unplanned deviation within two (2) working days of discovery. 11.2.2 Shall place the lot(s) in question on HOLD pending the X resolution/final approval of all deviations. 11.2.3 Shall follow the applicable SOP for investigating X unplanned deviations in order to determine the root cause, impact, and data disposition. 11.2.4 Shall forward a copy of the proposed retest plan, if X applicable, to Client Company Quality Assurance for review and approval prior to implementation. 11.2.5 Shall communicate if in agreement with the proposed X retest plan within two (2) working days of receipt from Contract Lab If in agreement, the retest plan will be approved by Client Company. Page 9 of 17
  10. 10. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 11.2.6 Investigations shall be approved within thirty (30) calendar X days of the date of discovery. 11.2.7 If an extension is required for the investigation, a written X request for extension shall be submitted to Client Company for approval prior to the due date. 11.2.8 Shall approve (or deny) due date extension requests X within one (1) working day of receipt. 11.2.9 Shall submit a written interim report to Client Company X within three (3) working days of the end of the 30 day timeframe. 11.2.10 Shall ensure that all corrective actions are closed within X the assigned due date. 11.2.11 If an extension is required for corrective actions, a written X request for extension shall be submitted to Client Company for approval prior to the due date. 11.2.12 Shall approve (or deny) due date extension requests X within one (1) working day of receipt. 11.2.13 Shall approve all investigations. X 11.2.14 Contract Lab will furnish Client Company a copy of all X approved investigation reports. 12.0 Change Control 12.1 Shall have established procedures for managing control of X changes to facility, equipment, critical computer systems, Product and Drug Substance specifications, and test methods. 12.2 May propose change requests related to Product and X X Drug Substance for review, which shall be managed through the Contract Lab Inc.’s change control process. 12.3 Changes proposed by Client Company will be forwarded X to the Regulatory/Quality Assurance unit at Contract Lab 12.4 Changes proposed by Contract Lab will be forwarded to X Client Company’s Regulatory/Quality Assurance unit for approval. 12.5 Shall obtain all necessary and appropriate regulatory and X quality approvals, as required, prior to authorizing any changes. 12.6 Upon approval from Client Company, Contract Lab will X initiate the changes, as defined by internal Contract Lab SOPs. 12.7 Ensures that only valid/current versions of the documents X are available for use. 12.8 Ensures that only valid/current versions of the documents X are used. 12.9 Ensures that outdated/non-valid versions of documents X are archived according to documented procedures, to prevent unintended use. Page 10 of 17
  11. 11. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 12.10 Shall ensure that all change control documentation will be X available to Client Company, upon request, for audit. 13.0 Data Acceptance and Disposition 13.1 Shall complete a review of all testing and control X documents within thirty (30) calendar days of the testing of Product(s) and Drug Substance. Both parties acknowledge that not all of the corrective actions and/or investigations may be completed within this timeframe, in which case Contract Lab will provide a written notification, with acceptable justification, for the time extension as specified in Section 11.2 of this Quality Agreement. 13.2 Shall certify for each batch of Product and Drug X Substance, that it was tested in accordance with cGMPs, internal procedures, ICH guidelines, and this Quality Agreement, by providing a Certificate of Analysis for release testing, and SLIM reports for stability testing, to Client Company. 13.3 Shall provide copies of the completed test records to X Client Company for each lot, which may include, but are not limited to, the following documents: • Completed testing records, including data analysis reports • Deviation, Discrepancy, and Out-of-Specification (OOS) investigations, including corrective and preventive actions taken • Certificate of Analysis, lab work request form, analysis report or SLIM report 13.4 Is responsible for final quality control release of Product to X the market. 14.0 Sample and Record Retention 14.1 Any portion of stability samples remaining after testing X shall be stored by Contract Lab in a temperature/humidity controlled storage area for sixty (60) days, unless otherwise requested by Client Company. 14.2 All documentation related to Product(s) and Drug X Substance, including reference standards, shall be kept in a manner to protect and secure the documentation against damage, destruction, unintended changes or disposal during the required time of storage. 14.3 The documentation shall be kept for a minimum of five (5) X years and subsequently must be made available for transfer to Client Company Quality Assurance at the end of the 5-year storage period. 14.4 For the archiving of data, media, diskettes, etc., the X original media and back-up copies shall be kept in a separate location protected against damage, destruction, and/or disposal during the required time of storage. 14.5 Data media shall be readable for the entire period that the X documentation is retained, and must be compliant with 21 CFR §11, as applicable. Page 11 of 17
  12. 12. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 15.0 Complaints and Recalls 15.1 In cases where Contract Lab is notified of any complaint, X Contract Lab will forward the complaint information to Client Company immediately (within one (1) working day) of such an event and will assist Client Company in taking prompt corrective actions. 15.2 Upon request by Client Company, shall investigate the X complaints, as required, and provide a written report on the results of the investigation to Client Company in not more than thirty (30) working days, or sooner, if agreed to, by both parties. 15.3 Shall communicate with the customers and/or regulatory X authorities the results of the complaint investigations, if necessary. 15.4 Shall provide complaint files to Client Company onsite, or X via facsimile within one (1) working day, if they are required during a FDA or other regulatory body inspection. 15.5 Recalls will be performed by Client Company according to X Client Company’s standard operating procedures. Contract Lab agrees to support these proceedings, if necessary. 16.0 Inspections and Audits 16.1 Visits 16.1.1 Shall permit Client Company to have manufacturing X and/or quality representatives present during Client Company's Product(s) and Drug Substance testing. 16.1.2 Client Company will provide at least three (3) working X days’ prior notification of their intention to witness scheduled testing. 16.1.3 Client Company representatives will be permitted to be X present in the testing area. 16.1.4 Client Company representatives in the plant will adhere to X Contract Lab’s quality and safety procedures and, for the purpose of regulatory compliance, will train on any of Contract Lab’s SOPs, policies or procedures, as deemed necessary by Contract Lab 16.1.5 Contract Lab shall also provide a key contact person, at X their facility, to communicate the Product(s) and Drug Substance quality-related issues during the testing. 16.2 Site Audits 16.2.1 Contract Lab agrees that Client Company, as well as any X other independent authority which Client Company and Contract Lab approve as a contract auditor, shall be entitled to audit the quality systems of Contract Lab, during mutually agreeable and reasonable times. 16.2.2 Contract Lab will provide a written response to the audit, X itemized by each observation, within thirty (30) calendar days after receipt of the written audit report. Page 12 of 17
  13. 13. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 16.2.3 A time schedule for follow-up and corrective actions will X X be mutually agreed upon between the parties. 16.2.4 Audits by Client Company’s partner may be conducted, X but only if scheduled through, and accompanied by, Client Company QA. 16.2.5 Notwithstanding the foregoing, Client Company, either X X directly, or in conjunction with its partner, may perform a for-cause audit (in addition to the annual audit, described previously) in cases where Contract Lab has quality systems issues or failures, resulting from or related to, FDA or other regulatory agency inspections, batch failure(s) related directly to handling, storage or testing of Product and Drug Substance by Contract Lab, or other quality issues which reflect the need for an audit in order to determine the continued compliance of Contract Lab with cGMPs, ICH guidelines and/or the requirements of this agreement. 16.3 Site Inspections 16.3.1 Contract Lab shall inform Client Company about any X communication received from regulatory agencies regarding Pre-Approval Inspections (PAIs) directly related to Client Company’s Product(s) within two (2) working days. 16.3.2 Representatives from Client Company may be present X during those portions of the PAI directly related to Client Company’s Product(s). The Client Company partner may be present as an observer, but is limited to two (2) representatives, and may not participate in the actual PAl. 16.3.3 Will cooperate in the development and review of X X responses required by the FDA or other regulatory authorities relating to Product and Drug Substance prior to submission. Nothing contained within this Quality Agreement shall restrict the right of either party to make a timely report of such matter to the FDA, or other regulatory authorities, or take other action that it deems to be appropriate or required by applicable law, rule or regulation. 17.0 Annual Product Review (commercial) 17.1 Shall be responsible for submitting Annual Product X Reviews to the FDA for Product. 17.2 Shall notify Contract Lab at least sixty (60) calendar days X prior to the close of the Annual Product Review reporting period, to ensure that Contract Lab is aware of the data submission deadline for Product. 17.3 Shall, upon request, provide Client Company with any X requested Product-related documentation updates for the purpose of annual regulatory report submission. 17.4 Any data prepared in support of an Annual Product X Review will be prepared and reviewed according to Contract Lab Inc.'s policies and procedures for commercial Product. Page 13 of 17
  14. 14. Contract Lab - CLIENT COMPANY Quality Agreement Responsibilities Client Contract Company Lab 17.5 The Annual Product Review documentation completed by X Contract Lab will be provided to Client Company within thirty (30) days of the close of the Annual Product Review reporting period, as mutually agreed to by both parties. 18.0 Subcontracting 18.1 Contract Lab may not delegate or subcontract to a third X party(ies) any part of the services to be performed by it under this agreement unless Client Company, or a Client Company affiliate, has expressly agreed, in writing, to such delegation or subcontracting. 18.2 No delegation or subcontracting on the part of Contract X Lab shall act to relieve Contract Lab from its obligations, duties or liability to Client Company, or a Client Company affiliate, hereunder. 18.3 Shall be liable to Client Company for the performance of X any delegate or subcontractor of its duties and obligations. 18.4 In the event that Contract Lab subcontracts or delegates X to a third party any obligations or responsibilities for the performance of services under this agreement, Contract Lab shall enter into a written contract with such third party. Such contract shall require the third party to comply with the terms and conditions of this agreement in the same manner as Contract Lab 18.5 Shall be responsible for any audits necessary to monitor X and assure such compliance related to Section18.4. 19.0 REVISION HISTORY Page 14 of 17
  15. 15. Contract Lab - CLIENT COMPANY Quality Agreement 20.0 COMMUNICATION CONTACTS Functional Area Contract Lab Contact Client Company Contact Main Switchboard Facsimile (FAX) Mailing Address Quality Assurance/ Qualified Person Regulatory Affairs Project Management Pharmaceutical Development Quality Control Page 15 of 17
  16. 16. Contract Lab - CLIENT COMPANY Quality Agreement Attachment A Events Requiring Client Company Notification 1. Deviations, Discrepancies, OOS, OOT, and Investigations 2. Stability failure or trend that could result in a failure 3. Contract Lab is contacted by a regulatory agent wanting to conduct an inspection 4. Contract Lab is contacted by a consumer, physician, pharmacist or regulatory agency of a Product complaint 5. Planned or unplanned changes to the facility that may impact Product performance (such as stability chambers, storage conditions, laboratory) 6. Planned or unplanned changes to the testing methods for Product and Drug Substance 7. Changes to controlled documents related to Product and Drug Substance 8. Inability to meet established timelines for completion of investigations and Corrective Action/Preventative Actions. Page 16 of 17
  17. 17. Contract Lab - CLIENT COMPANY Quality Agreement Attachment B Documents Requiring Client Company Signature 1. All Change Control requests related to Product and Drug Substance 2. All Method Validation protocols and final reports related to Product and Drug Substance 3. Memos requesting due date extensions for investigations or Corrective Action/Preventative Actions related to Product and Drug Substance 4. Product and Drug Substance Specifications 5. SOPs related to the testing of Product and Drug Substance, and stability program management for Product and Drug Substance 6. Analytical test methods used for release and stability testing of Product and Drug Substance 7. Method transfer protocols and reports 8. Stability protocols Page 17 of 17

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