Know the Regulations:Fostering the Quality-Based Sponsor/CMO               Relationship               EJ Brandreth
WelcomeEJ BrandrethSr. VP of Quality and RegulatoryAlthea Technologies, IncChairman, PDA Biotech BoardDirector, Interphex ...
Regulations for Parenterals (PDA)Some Key 21 CFR’s for CMO’s……•   Part 11 Electronic Records•   Part 200.10 Contract Facil...
CFR’s explain the What….but where is the How?Points to Consider in the….• FDA Guidance Documents…   • Guidance for Industr...
And a little of the Why…• USP; below <1000> are mandatory• WHO• Federal Register• Trade Articles; Journals• Gold Sheet• FD...
The CMO World: Wide Range of Clients          Big Pharma                         Virtual Biotech       Comprehensive QA   ...
The CMO World: Wide Range of Projects       Commercial Filling                 Phase 1                                    ...
The CMO World: Wide Range of Products Defined Product? Yes! It’s….   2 to100 ml clear or amber vials, 13 or 20 mm    coat...
Life in a CMOShowcase for EquipmentWeekly GMP audits by Clients  Constant Quality Input  Learn Best Practices Across t...
Life in a CMO: With all those inspections…  SOPs are very well written (they’ve been  independently reviewed 100+ times.....
Regulations and CultureAll Parties are Responsible and liable for CFR compliance  Recent WL (12-NWJ-12, 2/17/2012); “You...
Ownership Flow for Aseptic Filling at a CMO                 CONFIDENTIAL
Sponsor/ CMO RelationshipPerspectives on the Partnership1. Business-based approach;  •   Client and Vendor = Financial bas...
The PartnershipTwo over-arching considerations:1. Patient Safety Comes First2. cGMP Compliance Required  •   Required for ...
The Partnership• Ideally the value of a true Partnership is formed;  the CMO and Sponsor succeed or fail together• The CMO...
The PartnershipQuality Agreements:• Defines who is responsible for what• Defines timing of communications; error  reportin...
Hot CMO Topics Mold    Incidental, or tip of an iceberg? Visible Particles; overall reject rate    100% Visual Inspect...
Hot CMO Topics Weak Investigations   Lack of Root Cause, too much “Operator Error” =    “Retrain”   Lack of Data to sup...
Hot CMO TopicsShipping (Final Product) Under Quarantine  Both CMO and Sponsor are Responsible for   Adverse Outcomes  R...
ConclusionWhile working within the Regulations, establish a Positive Relationship with all three parties We all want Grea...
Thank youAlthea Technologies11040 Roselle St.San Diego, CA 92121Local Phone: 858-882-0123Toll-free: 1-888-425-8432Fax: 858...
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Fostering the Quality Based CMO-Sponsor Relationship

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Althea Technologies' Sr. VP of Quality and Regulatory, EJ Brandreth, talks about life in the CMO world from the quality perspective. In this presentation, he discusses the regulations involved in biologics manufacturing and fill finish operations, and the importance of establishing a quality based partnership between CMOs and sponsors.

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Fostering the Quality Based CMO-Sponsor Relationship

  1. 1. Know the Regulations:Fostering the Quality-Based Sponsor/CMO Relationship EJ Brandreth
  2. 2. WelcomeEJ BrandrethSr. VP of Quality and RegulatoryAlthea Technologies, IncChairman, PDA Biotech BoardDirector, Interphex BoardDirector, Biocom FDA Board CONFIDENTIAL
  3. 3. Regulations for Parenterals (PDA)Some Key 21 CFR’s for CMO’s……• Part 11 Electronic Records• Part 200.10 Contract Facilities• 210 & 211 cGMPs• Part 600 Biological Products• Part 601 Licensing• Part 610 Biological Products Standards• Part 820 Quality System Regulation CONFIDENTIAL
  4. 4. CFR’s explain the What….but where is the How?Points to Consider in the….• FDA Guidance Documents… • Guidance for Industry • Guidance for Reviewers, Reviewers and Sponsors, etc..• FDA Program Documents: “Inspection of…” (SOP)• ICH Guidelines• PDA Technical Reports, Journals CONFIDENTIAL
  5. 5. And a little of the Why…• USP; below <1000> are mandatory• WHO• Federal Register• Trade Articles; Journals• Gold Sheet• FDA Conference Presentations• EIR’s, 483’s, Warning Letters (actually “what not to do.. ”) daily emails• FDA “Dear xxxxx…. “ Letters CONFIDENTIAL
  6. 6. The CMO World: Wide Range of Clients Big Pharma Virtual Biotech Comprehensive QA Little QA Custom Quality Agreement No Custom Quality Agreement Financially Secure Small FundingLots of Experience with Submission Less Experience with Submission Process Process CONFIDENTIAL
  7. 7. The CMO World: Wide Range of Projects Commercial Filling Phase 1 Biological Processing Comprehensive History No GMP History Process Understood New Process Knowledge Deviations Rare Deviations Expected Wide, Deep Investigations Limited Investigations Tight Specifications Wide Specifications Low Risk Moderate Risk CONFIDENTIAL
  8. 8. The CMO World: Wide Range of Products Defined Product? Yes! It’s…. 2 to100 ml clear or amber vials, 13 or 20 mm coated or uncoated stoppers Viscosity 30-300 CPS Clear to opalescent to flocculent, may be opaque, blue, white Small Molecules, Proteins, Plasmids, Suspensions, Emulsions, Conjugates CONFIDENTIAL
  9. 9. Life in a CMOShowcase for EquipmentWeekly GMP audits by Clients Constant Quality Input Learn Best Practices Across the Industry Frequent EU GMP Audits by QPs Annual or Biennial FDA/EMA Inspections CONFIDENTIAL
  10. 10. Life in a CMO: With all those inspections…  SOPs are very well written (they’ve been independently reviewed 100+ times..) No major gaps in systems Personnel provide great tours; SME’s fluent in their systems CONFIDENTIAL
  11. 11. Regulations and CultureAll Parties are Responsible and liable for CFR compliance Recent WL (12-NWJ-12, 2/17/2012); “You state you have informed your clients on the importance of validating the methods…You are responsible for ensuring that the test methods used by your firm are validated.”Ownership is aMeandering Stream… CONFIDENTIAL
  12. 12. Ownership Flow for Aseptic Filling at a CMO CONFIDENTIAL
  13. 13. Sponsor/ CMO RelationshipPerspectives on the Partnership1. Business-based approach; • Client and Vendor = Financial based negotiations and decisions2. Quality-based approach; • Sponsor QA and CMO QA = Compliance based negotiations and decisions CONFIDENTIAL
  14. 14. The PartnershipTwo over-arching considerations:1. Patient Safety Comes First2. cGMP Compliance Required • Required for sponsor’s project. • From the CMO perspective, non-compliance affects all products, not just that one client. CONFIDENTIAL
  15. 15. The Partnership• Ideally the value of a true Partnership is formed; the CMO and Sponsor succeed or fail together• The CMO should be an extension of the Sponsor’s Quality System (CFR 200.10) • However, CMO quality systems are intricate and interconnected – have to serve many different client projects. • BUT Sponsor gains advantage of established, robust quality systems at CMOs. CONFIDENTIAL
  16. 16. The PartnershipQuality Agreements:• Defines who is responsible for what• Defines timing of communications; error reporting, OOS, FDA interactions, etc…• Should address GMP details which need specifics (e.g.: Sponsor determines Retain amount), but simply repeating cGMPs is Fluff. CONFIDENTIAL
  17. 17. Hot CMO Topics Mold  Incidental, or tip of an iceberg? Visible Particles; overall reject rate  100% Visual Inspection; Imperfect process, but continuous drive towards zero Glass Particles; shedding phenomena  Prevent/ Mitigate with knowledge of formulation Viral Contamination in Mammalian Systems  PDA TRs for Control, and Emerging Analytical Methods CONFIDENTIAL
  18. 18. Hot CMO Topics Weak Investigations  Lack of Root Cause, too much “Operator Error” = “Retrain”  Lack of Data to support assumptions and conclusions  Limited; to one product, or one production suite, or one test. Did not check to see if problem is actually present in other systems/programs  Corrective Actions; repeat offense?  Preventive Actions; repeat offense? PA Effectiveness program in place? CONFIDENTIAL
  19. 19. Hot CMO TopicsShipping (Final Product) Under Quarantine Both CMO and Sponsor are Responsible for Adverse Outcomes Rare Event; Urgent Need, Stock-Out Situation Per a Deviation, and Legal Agreement Sterility Test Results Required prior to shipment Visual Inspection Completed prior to shipment CONFIDENTIAL
  20. 20. ConclusionWhile working within the Regulations, establish a Positive Relationship with all three parties We all want Great Products Released We all have financial and scheduling pressures We all are held accountable to the RegulationsFoster the Relationship; Communicate, Document Every Detail, Deliver CONFIDENTIAL
  21. 21. Thank youAlthea Technologies11040 Roselle St.San Diego, CA 92121Local Phone: 858-882-0123Toll-free: 1-888-425-8432Fax: 858-882-0133 CONFIDENTIAL
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