Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants

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1 Best Practices In Ensuring Quality Standards When Outsourcing To Contract Manufacturers, Licensees And Consultants Alex D. Kanarek, PhD BioProcess Technology Consultants, Inc. Strategic Institute Quality & Regulatory Strategies Summit Toronto, Ontario March 5/6, 2009

2 Agenda Outsourcing Overview: Contract Manufacturers Licensing Out Use of Consultants Regulatory Environment CMOs, Contracts & Quality Agreements Ensuring Quality by Partnering PIP, Inspections & Audits Key Take-Home Points Discussion From Clone to Commercial 2

3 CMO Outsourcing Overview Transfer of Sponsor s Technology Product Development Process Development Manufacture: Clinical & Commercial Process Validation (FDA: Process Performance Qualification ) Analytical Method Development & Validation From Clone to Commercial 3

4 Best Practices in Technology Transfer Have a well-defined TT process (written) Define roles and responsibilities clearly Use software-based planning & scheduling devices such as SuperPro or MS Project to ensure no bottlenecks or conflicts Some examples of pitfalls: Process uses custom raw materials (short supply?) Long lead equipment will delay project Instrument calibration tolerances do not match process needs Column packing requirements not clearly defined Mixing or filtration studies needed with different equipment Hold times may vary stability concerns? From Clone to Commercial 4

5 Example of SuperPro Equipment Conflict Chart From Clone to Commercial 5

6 CMO Development Activities Product Development, e.g.: Expression System Development/Improvement Cell Line Selection Formulation Development Process Development, including: New Process Creation Existing Process Improvement Scale-up Studies Process Validation CMO should have the expertise, but may not FDA Rules on Validation are changing From Clone to Commercial 6

7 Clinical and Commercial Manufacture CMOs vary significantly in Capacity and Experience Differing GMP Requirements for Phase I thro III Commercial Manufacture uses Validated Processes and Methods CMO must have Functional Quality Unit (QA/QC) From Clone to Commercial 7

8 Analytical Method Development & Validation Essential Part of Product Development Often outsourced possibly to another contractor Contractor Provides Specialized Expertise & Equipment, for Characterization Potency Assays Impurities Profile Problems Bringing method in-house Demonstrating robustness From Clone to Commercial 8

9 Licensing Out Early-stage Products Not usually done originator loses control More often the research is sold to Big Pharma Or, there is a joint venture for further drug development Products in Clinical Trial Licensee shares or undertakes the cost of clinical manufacture and testing and the trials If Licensee manufactures in-house, Quality Agreement needed If Licensee uses a CMO, the rules still apply Approved Products Licensee must comply with all provisions of the Marketing Approval From Clone to Commercial 9

10 Consultants Work in-house or with other contractors Provide specialized expertise and advice Consulting agreement contains quality clauses Typical Consultants Services: Product/Process Development Process/Method Validation In-house Audits for Regulatory Compliance Assistance with Training Programs Assistance with Documentation/Submissions Supplier Audits Selecting, Monitoring, Auditing CROs, CMOs; may be PIP From Clone to Commercial 10

11 The Basic GMP Regulations (1) Canada Federal Drug Regulations Division 2, Part C Need for Establishment License GMP Guidance 2002, revised draft for comments Defines Quality Management System, QA/QC QA ensures that Outsourced activities are subject to appropriate controls and meet GMP requirements Specifies qualifications/experience of responsible staff USA Regulations, 21CFR for all drugs, 600 series for biologics, 820 for devices All facilities must be registered No specific mention of outsourcing in 21CFR211 Guidance on split manufacture of biologics Nov From Clone to Commercial 11

12 However, A Recent FDA Warning Letter Stated: Specifically, your firm has not established and approved quality system procedures that delineate the specific responsibilities and manufacturing operations for each of your contract manufacturing facilities From Clone to Commercial 12

13 The Basic GMP Regulations (2) EU Regulations EUDRA Volume 4 + Annexes Chapter 7 Contract Manufacture & Analysis Defines responsibilities of both parties clearly. Some following slides are based on this chapter. ICH Q7: Guidance on GMP for APIs Section 16: Specific provisions for contract manufacturers Must comply with GMP sponsor to evaluate Must allow sponsor audits Written contract Sponsor approves changes From Clone to Commercial 13

14 General GMP Provisions USE QUALITY SYSTEM MANAGEMENT (& Risk Evaluation) for: Proper Design & Operation of Facilities & Equipment Control of Raw Materials and Components Adequate Qualification & Training of Staff Written Procedures for all Critical Activities Quality Control of In-Process & Final Product To preset specifications Full Records of Manufacture & Testing Validation of Processes and Test Methods Process Change Control & Documentation From Clone to Commercial 14

15 The Ideal CMO: Has the competence to manufacture/test the product Complies with the quality standards of the sponsoring company Has the necessary legal manufacturing authorizations Has an infrastructure and culture capable of providing accurate, comprehensive and timely information Provides a good fit with the Sponsor s corporate culture Has the capacity to meet product demand for clinicals or sales Can supply the product at an acceptable cost/dose Has commitment to your business and can deliver orders on time and in full Is a secure business capable of long-term tenure of supply, which invests sufficiently in maintaining up-to-date technologies. From Clone to Commercial 15

16 Managing the Relationship The Sponsor should: Provide dedicated project management/contact person(s) Maybe a Person in the Plant (PIP) Maintain clear communication channels Provide for conflict resolution Manage overly optimistic deliverable requirements The CMO should: Be attuned to a cultural fit with the sponsor Be a good partner Be responsive to sponsor s needs & concerns Manage overly optimistic forecasts From Clone to Commercial 16

17 CMO Contracts & Quality Agreements There must be a Written Contract Defining the Responsibilities of: The Sponsor Technology Transfer QA/Regulatory Support The Contractor To use established processes or develop new ones To comply with GMP Providing an Assurance of Quality In Contract or Separate Agreement All arrangements must be in accordance with the marketing authorization (if it exists) From Clone to Commercial 17

18 Define the Responsibilities (1) The Contract Giver is responsible for assessing the competence of the Contract Acceptor to carry out successfully the work required and For ensuring by means of the contract that the principles and guidelines of GMP... are followed. - EUDRA Vol. 4, Chapter 7. From Clone to Commercial 18

19 In Other Words... The Sponsor Retains overall responsibility for compliance Must have a Quality Assurance/Quality Control unit Must assess, monitor and audit the CMO s operations Must perform annual product quality review with CMO Will prepare and submit the CTA, NDS, etc. (IND, NDA) From Clone to Commercial 19

20 Define the Responsibilities (2) The Contract Acceptor must have adequate premises and equipment, knowledge and experience, and competent personnel to carry out satisfactorily the work ordered by the Contract Giver. Contract manufacture may be undertaken only by a manufacturer who is the holder of a manufacturing authorization. EUDRA. From Clone to Commercial 20

21 In Other Words The CMO Must be in compliance with GMP, according to the phase of manufacture Must have a QA/QC Unit Must work to Master Formulae (MBR) and maintain full Batch Production Records Must monitor and audit internally Must be licensed or registered with Regulatory Agency From Clone to Commercial 21

22 Define the Responsibilities (3) Consultants and Contract Auditors Are required to have appropriate training and qualifications Must comply with GMP Contract Giver must record Consultant s qualifications The services provided From Clone to Commercial 22

23 The Quality Agreement Quality systems call for contracts (quality agreements) that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms FDA Should Summarize: The Sponsor s expectations The CMO s commitment Should Contain: A Reference to the relevant Regulations The Agreed Specifications of In-process and Final Product Provision for QA Oversight (by Sponsor and Contractor) System for product approval/release Should Define the handling of Deviations/Errors/OOS Results From Clone to Commercial 23

24 Quality Agreements Opinion from FDA Should clearly outline all responsibilities of both parties for notification of manufacturing-related issues to one another Should contain a full description of all reporting relationships for issues related to contract manufacturing operations based upon the nature of the relationship Dr. Mark Elengold, CBER Deputy Director, Operations From Clone to Commercial 24

25 Questions to Answer Opinion from FDA How is information shared specific to investigations of deviations? How is the contract manufacturer going to evaluate changes in equipment and facility use that may impact on the product, and how will they notify the license holder? Who has ultimate responsibility for the product and does this entity have full access to all potential product impacts or contractor operations? Elengold From Clone to Commercial 25

26 Compliance Assurance - Initial Audit Investigate: The competence of the Contractor s staff, His history of successful projects, His SOPs for all manufacturing & control operations, The results of previous Audits and Regulatory Inspections, DMFs filed Inspect the plant, QMS, operations, validation reports, production records etc. From Clone to Commercial 26

27 Compliance Assurance During Operations Clearly define all critical GMP compliance requirements in the contract Have a Person in the Plant (PIP) if necessary Arrange for periodic QA visits to inspect (audit) actual manufacturing of the contracted product Obtain process validation reports as they are generated Ensure QC testing is done with qualified methods Ensure that production/testing records are complete and accurate. Ensure notification of all process/testing deviations and that all OOS results are investigated From Clone to Commercial 27

28 Ongoing Surveillance FDA s Recommendations Ask to be notified of all changes which could affect the processing of your (approved) product New equipment Change in key personnel Change in test methods Change in SOPs Ask to be notified when the contract facility is visited by the FDA Ask for a copy of all FDA-483s which are issued to the firm Ask to be notified if a test result was obtained as a result of a retest (and why ) From Clone to Commercial 28

29 The Person in Plant Friend? The primary conduit of information between the two companies Will help coordinate production schedules, document reviews/approvals, and general project-related tasks Will personally observe batch manufacturing activities May conduct site audits, if qualified Must be able to communicate progress, issues, concerns and questions to sponsor colleagues And communicate responses to CMO staff CMO will expect the PIP to have authority to participate in onthe-spot trouble-shooting and be able to make decisions regarding product quality when anomalies occur, But From Clone to Commercial 29

30 The Person in Plant or Foe? It is rare for the PIP to have the authority to approve products for continued processing when a process deviation or OOS is encountered Sponsor s QA Unit must be involved Must be a consummate politician Will always be the outsider looking in Everyone at the CMO is aware that they are being observed May be a drain on CMO resources May have to function as a partner, mentor, auditor and project sponsor simultaneously Must always be careful not to interfere with operations Can create liability problems Can enhance or destroy a sponsor s relationship with a CMO From Clone to Commercial 30

31 Sponsor s Inspections & Audits Use the Six Systems Approach: Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program, Implemented February 2002 Apply Risk Analysis to determine critical processes/procedures to inspect From Clone to Commercial 31

32 The Six Systems 1) Quality System - Always inspect this! a) SOPs & other Document Management b) QA Audit Reports, Internal & External c) Regulatory Inspection Reports (Canada Inspection Exit Notice, FDA Form 483), Warning Letters 2) Facility & Equipment walk through a) Environmental Control & Monitoring b) Staff & Materials Movement Control c) Equipment Placement, Maintenance & Calibration d) Cleaning Validation 3) Materials a) Raw Material & Container Specifications Vendor Audits From Clone to Commercial 32

33 The Six Systems, continued 4) Production a) SOPs for standard operations being followed? b) Critical procedures qualified/validated? c) Batch records critical measurements countersigned? 5) Packaging & Labeling as needed 6) Laboratory Control a) Using agreed test procedures & specifications? b) Qualified/validated methods c) OOS Investigations From Clone to Commercial 33

34 Data Audits Should confirm the accuracy and integrity of reported data and results. Involve comparison of batch records and reports with raw data, e.g.: Operators in-process records, Analysts laboratory notebooks. Should also cover deviation reports and failure analyses. From Clone to Commercial 34

35 What Can Go Wrong? A 2007 survey revealed the following TOP 6 Categories of COMPLAINTS: Type of Complaint Percentage of Respondents Competence 21.4% Quality 13.1% Communication 13.1% Delivery 11.9% Customer Service 10.7% Costs 7.1% Source: Contract Pharma From Clone to Commercial 35

36 Some Recommended Best Practices Appoint a Technical Product Owner To follow product over the entire life cycle Continuity is critical External Quality Manager must be technically competent Often a Sponsor s resource constraint Key Performance Indices should be well defined Establish clear time-frames for responses either way Encourage the CMO to Think, not just Do Continuous Improvement is the Aim Remember - Your CMO is Your Partner From Clone to Commercial 36

37 Finally Questions? Comments? Thank You BioProcess Technology Consultants, Inc. 289 Great Road, Suite 303 Acton, MA USA (phone) (fax) www,bioprocessconsultants.com From Clone to Commercial 37

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