Quality System Expectations : Single-Use Materials

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Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.

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Quality System Expectations : Single-Use Materials

  1. 1. Quality System Expectations Disposables (Single-Use Materials) use in the Manufacture of Drugs and Biologics Bill Holden Global Quality Leader W. L. Gore & Associates, Inc. Gore PharmBIO products
  2. 2. Agenda Single-Use Technologies Movement cGMP CFR 820 Applicable Practices Supplier Qualifications Material Qualifications Minimal Quality System Standards
  3. 3. Single-Use in Pharma & Biotech Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
  4. 4. What is the Movement? Increased availability of Single-Use materials are replacing traditional stainless steel processes. – Use in Single batch or limited campaigns – Reduced process validations – Validations allow for re-usable elements
  5. 5. Advantages Decreased Cycle times (Batch to Batch) Decrease Overall Captial Investment Decreased Labor Decreased New Product Introductions time Increased Flexibility Increased Potential Capacity Decreased In Process Waste
  6. 6. Disadvantages New Extractables/ Leachables must be determined for product Increased cost of consummables Increased need for Vendor Audits Qualified Supply Sources are limited Increased potential for scrap of unused components More Solid Waste
  7. 7. The Path to Single-Use Process Systems Traditional Single-use stainless BioProcess steel Container Systems Large capital Less capital SIP No SIP CIP No CIP validation validation
  8. 8. Ameican Pharmaceutical Review ( See web links References and Resources)
  9. 9. Supplier Qualification (Expectations) Limited Validated Suppliers Expectations of Minimal Quality Standards Applicable cGMP standards ISO cGMP 21 CFR 820 Extractable CARS/ PARS Audit Supply Training Robust Control Quality Traceability System
  10. 10. Applicable cGMP 21 CFR 820 Applicability 820.1 (a) – Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. – If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.
  11. 11. Suggested Applicable Requirements for tubing Molded Manifolds Subpart B--Quality System Requirements § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. Subpart C--Design Controls § 820.30 - Design controls. Subpart D--Document Controls § 820.40 - Document controls. Subpart E--Purchasing Controls § 820.50 - Purchasing controls. Subpart F--Identification and Traceability § 820.60 - Identification. § 820.65 - Traceability. Subpart G--Production and Process Controls § 820.70 - Production and process controls. § 820.72 - Inspection, measuring, and test equipment. § 820.75 - Process validation. Subpart H--Acceptance Activities § 820.80 - Receiving, in-process, and finished device acceptance. § 820.86 - Acceptance status.
  12. 12. Suggested Applicable Requirements for tubing Molded Manifolds Subpart I--Nonconforming Product § 820.90 - Nonconforming product. Subpart J--Corrective and Preventive Action § 820.100 - Corrective and preventive action. Subpart K--Labeling and Packaging Control § 820.120 - Device labeling. § 820.130 - Device packaging. Subpart L--Handling, Storage, Distribution, and Installation § 820.140 - Handling. § 820.150 - Storage. § 820.160 - Distribution. § 820.170 - Installation. Subpart M--Records § 820.180 - General requirements. § 820.181 - Device master record. § 820.184 - Device history record. § 820.186 - Quality system record. § 820.198 - Complaint files. Subpart N--Servicing § 820.200 - Servicing. Subpart O--Statistical Techniques § 820.250 - Statistical techniques.
  13. 13. Basic Requirements (Manufacturing) ISO 9001:2008 3rd Party certification Demonstrable Quality System – Responsible Quality Unit/Team – Trained, responsible production team members – Appropriate Document Management System Controlled Documents Demonstrable Procedures, Work Instructions, etc.
  14. 14. Basic Requirements (Manufacturing) Viable Preventative and Corrective Action Systems Controlled and verified suppliers – Approved supplier list – Verified materials (TSE/BSE Policy) Identification and Traceability Systems – Manual or Electronic
  15. 15. Basic Requirements (Manufacturing) Appropriate Production Controls – In Process Assurance of Intermediate Assembly – In Process Traceability – In Process Acceptance Standards – Equipment Validations/ Calibrations/ Preventative Maintenance Appropriate isolation and identification of non- conforming product – Segregation/ labeling, and disposition
  16. 16. Basic Requirements (Manufacturing) Organized Handling Operations – Controlled labels and identification of parts and components – Assurance of packaging integrity of parts and components – Assurance of cleanliness of parts and components – Viable location traceability (manual or electronic)
  17. 17. Basic Requirements (Manufacturing) Records – DMF/DHF- Batch History Record Includes the Bill of Materials (BOM, Drawing, additional customer specifications) Assures traceability of part manufacture and raw components Assures any linkage from customer complaint can be made.
  18. 18. Basic Requirements (Manufacturing) Internal Audits – Yearly Internal Evaluations Facilities – Clean and Organized – Bioburden/ Particulate readings – Appropriate environmental and disposal controls for the parts manufactured. – Pest control program and maintenance
  19. 19. Basic Requirements (Materials) Sterilization method /validations (GAMMA/ STEAM, etc. ) Chemical Compatibility Physical Properties Extractables Test Data Biocompatibility (USP VI Test Data) Applicable Materials Testing – Application specific testing Endotoxin Bioburden FFU (Fitness for Use) specific testing
  20. 20. Methods of Evaluation Desktop Audit Supplier Visit/Audit Data Review Supplier Performance Data – Delivery – Corrective Actions – Collaborations
  21. 21. Desktop Survey Frequent Topics:
  22. 22. Additional Resources References – Froimson, Joshua. American Pharmaceutical Review. 2009. 12, 2 20-27. – Sinclair, Andrew, Monge, Miram. International BioPharm. 2008. 21, 12 27-29. – Strahlendorf, Kirsten A. Kevin Harper. American Pharmaceutical Review. 2009. 12, 4 28-37.
  23. 23. Additional Resources Web Resources – http://www.futurepharmaus.com/?mc=disposable&page=mt-viewarticle – http://www.pharmamanufacturing.com/articles/2007/164.html – http://www.pharmpro.com/ShowPR.aspx?PUBCODE=021&ACCT=0000100&ISSUE=0604 &RELTYPE=PR&ORIGRELTYPE=ATO&PRODCODE=0000&PRODLETT=A&Commo nCount=0 – http://biopharminternational.findpharma.com/biopharm/Disposables/Final-Word-Disposable- Systems-Meet-Todays-Manufact/ArticleStandard/Article/detail/146352 – http://www.bioplanassociates.com/publications/articles/Bp0607_DisposablesAsDisruptive_J un07.pdf – http://www.pharmamanufacturing.com/articles/2004/27.html?page=full Additional Meetings – http://www2.ispe.org/annualmeeting2009/education/402.cfm – http://www.pharmpro.com/singleuse/ – http://www.advantagemedia.com/ims/scripts/RegisterEventLink.asp?ID=79 – http://www.ispe.org/cs/2009_strasbourg_conference/disposables_and_containment_technolo gy – http://biopharminternational.findpharma.com/biopharm/Disposables+Advisor/User- Viewpoints-on-Disposables- Implementation/ArticleStandard/Article/detail/601411?contextCategoryId=35801
  24. 24. Additional Resources http://biopharminternational.findpharma.com/biopharm/s ervlet/ContentRatingServlet#rating_anchor http://biopharminternational.findpharma.com/biopharm//a rticle/articleDetail.jsp?ts=081709022143&id=608683 http://biopharminternational.findpharma.com/biopharm/a rticle/articleDetail.jsp?id=608683&pageID=1&sk=&date = http://www.in-pharmatechnologist.com/Processing- QC/GE-Healthcare-and-Novavax-collaborate-on- pandemic-flu-solution

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