CBER Expectations Regarding Contract Manufacturing
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1 CBER Expectations Regarding Contract Manufacturing LCDR Qiao Bobo, Ph.D. FDA/CBER/OCBQ/DMPQ CASSS CMC Strategy Forum Summer 2014
2 Outline 2 Types of Cooperative Manufacturing Arrangements CBER Expectations Licensed Manufacturer Responsibilities Contract Manufacturer Responsibilities Case Studies Quality Agreements Quizzes
3 Guidance for Industry November Guidances/General/ucm pdf
4 Types of Cooperative Manufacturing Arrangements 4 Divided Manufacturing - two or more manufacturers, each registered with FDA in accordance with 21 CFR Parts 207, 607, or 807 as applicable, and licensed to manufacture a specific biological product in its entirety, participate jointly in the manufacture of that product.
5 Types of Cooperative Manufacturing Arrangements 5 Shared Manufacturing - two or more manufacturers are licensed and responsible for specific aspects of the manufacture of a product but none is licensed for all aspects of the manufacture of the product. Company A is licensed to manufacture the bulk drug substance and Company B is licensed to manufacture the final drug product.
6 Types of Cooperative Manufacturing Arrangements 6 Contract Manufacturing - a licensed manufacturer establishes a contract with another entity(ies) to perform some or all of the manufacture of a product as a service to the licensed manufacturer. A contract facility that is engaged in significant manufacturing is not required to be separately licensed, as is the case in a Shared Manufacturing Arrangement.
7 Contract Manufacturing Facilities 7 Contract Manufacturing Facilities (21 CFR ) Bulk Drug Substance Manufacturers Drug Product Manufacturers Testing Laboratories Labeling Packaging Warehouse
8 Responsibilities of Licensed Manufacturer 8 The licensed manufacturer must have a procedure in place for receiving information from the contract facility on all deviations, complaints, and adverse events (21 CFR (a)). Final approval or rejection of drug product to the market (211.22(a)).
9 WL to Product Owner: Disposition 9 Your firm is the owner of this drug product, but did not adequately evaluate whether the CMO, which is an extension of your operations, can consistently produce product that is suitable for distribution. For example, your quality unit did not evaluate the quality of each batch of drug product produced by the CMO in order to make an appropriate disposition decision (approval or rejection). Your finished product, XXXX, was not tested for conformance to the labeled amount of active ingredients. Your firm contracted out the XXXX product. Your firm accepted and relied on the Certificate of Analysis (COA) from your contract manufacturer (CMO) and failed to verify the accuracy and completeness of testing results in the COA. For example, XXXX contains six active ingredients. The COA for this lot showed that only identity testing for two of the six active ingredients was conducted. No assay testing was conducted.
10 Responsibilities of Licensed Manufacturer 10 The licensed manufacturer should be aware that all contract manufacturing locations must be in compliance with CGMP regulations and are subject to inspection from the time of the submission. The FDA regards these locations as an extension of the licensed manufacturer s own facility (21 CFR ).
11 Issuance and Denial of License (601.4) 11 A license will not be issued unless the product and establishment(s) meet the applicable standards. Such an issuance is for the relevant establishments and applicable standards.
12 . Responsibilities of Product Owner - Scenario 1 12 Pre-approval inspection of a BLA owner revealed that the fill volume size as stated in the BLA was filled at a contract facility. The contract facility was located in a different country, was not registered and had never been inspected before. Outcome - The review clock was stopped in the form of a CR letter stating outstanding compliance issues with regard to your contract filling facility, as this facility has no compliance history. End result is no product to the market at that time.
13 Responsibilities of Product Owner - Scenario 2 13 The product owner submitted a PAS for an alternative contract facility to manufacture a bulk drug substance. The FDA compliance check revealed that the contract facility was under an OAI (Official Action Indicated) for another product. Outcome A CR letter was issued due to outstanding compliance issues based on the inspection conducted on XXXX date..
14 Responsibilities of Contract Manufacturer 14 Contract facilities are subject to FDA inspection under section 351(c) of the PHS Act and section 704(a) of the FD&C Act. Facilities performing contract operations for biological products must register with FDA in accordance with registration and listing provisions in 21 CFR Parts 207, 607 and 807.
15 Expectations of Contract Manufacturer 15 Ensure full compliance to CGMP to the operations being performed. Allow the licensed manufacturer to regularly assess the contract manufacturing facility s compliance. This may include, but is not limited to, review of records and manufacturing deviations and defects, and performance of periodic audits.
16 WL to Contracted Facilities: CGMP Violation 16 you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this CGMP violation. You are responsible for ensuring that the test methods used by your firm are validated. Data generated by an unvalidated method(s) should not be used for establishment of expiration dates, commercial batch release, or other CGMP decisions.
17 Expectations of Contract Manufacturer 17 Should ensure the notification to the licensed manufacturer of any FDA list of inspectional observations related to the contracted product. Fully inform the licensed manufacturer of the results of all tests and investigations regarding or possibly having an impact on the product. Notify the licensed manufacturer of any changes.
18 WL to Contracted Facilities: Data Integrity and Notification 18 Please note that as a contract testing laboratory, it is your responsibility to ensure the integrity of the data generated and that all test results be properly documented, maintained and reported. Failure to investigate OOS: Please indicate if all your customers were notified of these failures and date of notification.
19 Expectations of Contract Manufacturer 19 Allow the licensed manufacturer access to floor plans, equipment validation, and other production information. Note that this information will be submitted to FDA by the applicant as part of the submission
20 21 CFR The FDA does not consider results of validation studies of analytical and assay methods and control procedures to be trade secrets that may be withheld from the drug manufacturer by the contract facility.
21 Contract Manufacturing Facilities 21 Contract Manufacturing Facilities (21 CFR ) Bulk Drug Substance Manufacturers Drug Product Manufacturers Testing Laboratories Labeling Packaging Warehouse
22 21 CFR In accordance with 21 CFR , FDA may disclose any information obtained during the inspection of a contract facility having a specific bearing on compliance with the FD&C Act to the licensed manufacturer. The FDA s position is that by accepting contract work, the contract facility authorizes such disclosures.
23 WL to Contracted Facility: CC Your Customers! 23 Your firm does not have adequate written procedures for production and process controls [under (a)] You conducted validation activities for only products X and Y, which you deemed to be the worst case products you have not provided a scientific rationale to demonstrate that the mixing studies for X and Y are adequate and fully representative for the other 118 products Unless you are able to demonstrate that your matrix approach is scientifically sound, all products must be individually validated. Copies of WL to CEOs of five of Contracted Facility s customers.
24 Draft Guidance - May
25 Quality Agreement 25 The CGMP regulations don t explicitly require a written quality agreement, but 21 CFR (a): QU responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company 21 CFR (d): QU procedures & responsibilities must be in writing 21 CFR : contract manufacturers are an extension of the manufacturer s own facility Quality Agreement can be a tool that is used to ensure all establishment standards and applicable regulations are followed.
26 Scope of Draft Guidance 26 What is covered: human drugs, veterinary drugs, biological and biotechnology products, finished products, active pharmaceutical ingredients (APIs or drug substances, or their intermediates), and drug constituents of combination drug/device products manufacturing includes processing, packing, holding, labeling operations, testing, and operations of quality unit What is not: Type A medicated articles and medicated feed, medical devices, dietary supplements, or HCT/Ps qualification activities, auditing, or disqualification of contracted facilities controls related to qualification, auditing, monitoring, or disqualification of suppliers of raw materials or ingredients, including recommendations for Quality Agreements with vendors/suppliers distributors
27 Purpose 27 Outlines critical roles played by both Product Owners and Contracted Facilities Explains how manufacturers should use Quality Agreements to define, establish, and document their responsibilities Emphasizes that Quality Agreements should: Promote communication between the parties Clearly delineate the parties responsibilities, especially with respect to quality issues Assure coverage of all CGMP requirements Provide for change management
28 Basic Sections and Elements 28 Basic Sections: Purpose/Scope Terms (including effective date and renewal/extension) Dispute Resolution how will disagreements be elevated to decisionmakers in each company (not ADR or arbitration, etc.) Responsibilities, including communication mechanisms & contacts Change control and revisions Critical Elements from cgmp Perspective Responsibilities: Quality Unit, Facilities and Equipment, Material Management, Product Specific Terms, Laboratory Controls, Documentation Change Control
29 Change Control 29 Changes can be initiated by either party Contract Facility should notify the Owner of the changes, including but not limited to: Raw materials Establishment locations Manufacturing processes Additional product brought in Changes in equipment, shipping methods, container closures Owner in turn must then submit the changes based upon 21 CRF , and or Expectation that there will be documentation to support the change.
30 Quizzes - So who is responsible? 30
31 Quiz 1 - Change Control 31 A Contract Facility informed the Owner about obvious powder segregation issues. Correction of the issues involved major changes that would require re-designing the process, changing raw material specifications and submission of a PAS to the FDA The Contract Facility could not make changes without the Owner s approval. The Owner refused to approve the change. The Contract Facility continued manufacturing the product using the flawed process.
32 Quiz 2 Equipment Maintenance and Upkeep 32 FDA inspection revealed deficient maintenance of the facilities and equipment such as defective or partially broken equipment, visibly tarnished piping, leaking seals, etc. In addition, facility design is inadequate to prevent contamination. This Contract Facility has a Quality Agreement specifying the Owner s responsibility for upgrades and maintenance of the facilities and equipment. The Owner fails to provide the requisite resources or carry out the necessary upgrades and maintenance, but the Contract Facility continues to manufacture the product under non-cgmp conditions that could result in product contamination.
33 Quiz 3 Documenting Steps in the Manufacturing Process 33 Inspection of Contract Facility revealed that batch records do not accurately reflect the actual manufacturing process. The Contract Facility claims that this practice of incomplete batch records was in accordance with the wishes of the Owner.
34 Bottom Line 34 A Quality Agreement Can be used as a tool to help ensure that all responsibilities and expectations are met. A Quality Agreement is not a substitute for compliance with CGMP requirements by either party The Contract Facility cannot essentially agree to manufacture under non-cgmp conditions The Owner is not relieved of its responsibility to ensure the quality and safety of the product introduced into interstate commerce FDA could also inspect the Owner and if necessary take regulatory action based on oversight failures in monitoring the activities of the contract facility.
35 References 35 Guidance for Industry - Cooperative Manufacturing Arrangements for Licensed Biologics November 2008 Draft Guidance for Industry - Contract Manufacturing Arrangements for Drugs: Quality Agreements May 2013
36 Acknowledgements 36 Paula Katz - Acing Branch Chief, FDA/CDER/OC/OMPQ Nancy Waites - Consumer Safety Officer, FDA/CBER/OCBQ/DMPQ Marion Michaelis - Branch Chief FDA/CBER/OCBQ/DMPQ Laurie Norwood Deputy Division Director FDA/CBER/OCBQ/DMPQ John Eltermann - Division Director FDA/CBER/OCBQ/DMPQ Mary Malarkey - Director, Office of Compliance FDA/CBER/OCBQ
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