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Integration of Good Engineering Practice (GEP) into the Pharmaceutical Quality System

Integration of Good Engineering Practice (GEP) into the Pharmaceutical Quality System. GEP. Good Practices in the Life Cycle of Medicinal Products. ?. Good Laboratory Practice. Good Clinical Practice. Good Manufacturing Practice. GXP. Good Distribution Practice. Good Pharmacy Practice.

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Integration of Good Engineering Practice (GEP) into the Pharmaceutical Quality System

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  1. Integration of Good Engineering Practice (GEP) into the Pharmaceutical Quality System

  2. GEP Good Practices in the Life Cycle of Medicinal Products ? • GoodLaboratoryPractice • Good • Clinical • Practice • GoodManufacturing Practice GXP • GoodDistributionPractice • GoodPharmacyPractice

  3. GMP&GEP Definitions EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary UseEudraLex, Vol. 4 ISPE Baseline Pharmaceutical Engineering Guide.Vol.5. Commissioning and Qualification. ISPE, 2001

  4. Goals and Relation between GEP andGXP

  5. GEP & GXP Application to Manufacturing Systems Manufacturing Systems (impact on quality) Indirect Impact No Impact Direct Impact Engineering activities / Commissioning (С) / GEP ISPE Baseline Pharmaceutical Engineering Guide.Vol.5. Commissioning and Qualification. 1st Edition.- ISPE, 2001. Regulatory activities /Qualification (Q) /GXP

  6. GEP in the Life Cycle of the Manufacturing Systems ASTM E2500: Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

  7. GEP and GMPApplication to a Critical Manufacturing System Critical Manufacturing System (Impact on Drug Quality)

  8. Key Elements for GEP Confirmation • GEP Guide • Description of the requirements to facilities in URS • Application of Project Management tools • Written Procedures for execution of engineering activities • Records for executed engineering activities • Maintenance Programs and Plans, based on the assessment of all applicable engineering aspects of the facilities(Design, Criticality, Operation, etc.) • Monitoring of Effective Use of the manufacturing systems, maintenance and other engineering activities including trend analysis • Cost Management for engineering activities • Management throughout the life cycle phases of the manufacturing systems • Internal Audits of engineering management • Suppliers Managements for equipment, spare parts and services

  9. Common Areas and Tools of GEPand GXP

  10. GEPas a Management System

  11. GEP as a Part of the General Compliance Management System Compliance Management System Quality Management SystemISO 9001 Engineering Management SystemGEP Pharmaceutical Management SystemGXP Environmental Management System ISO 14001

  12. Sample of GEP & QMS Integration (NNE Pharmaplan) QMS GEP Our Model QMS Procedures (63) GEP Standards and Guidelines (app. 400 articles) Our Wiki

  13. Benefits of GEP Implementation • «Smooth» Project Execution • Cost Optimization for Engineering Activities and Facilities • Achievement and Maintenance of appropriate Project Quality • Proper Operation and Maintenance of Manufacturing Systems • Support of Regulatory Activities (GXP) • «Synergetic» Use of available Resources in Management

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