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

Storage and distribution Good Practices in the Life Cycle of Medicinal Products GLP GCP GMP GDP GPP ? Good Laboratory Practice Development Clinical trials Manufacture Storage and distribution Retail GEP Good Clinical Practice Good Manufacturing Practice GXP Good Distribution Practice Good Pharmacy Practice

GMP & GEP Definitions Good Manufacturing Practice (GMP) A part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation, Clinical Trial Authorisation or product specification EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use EudraLex, Vol. 4 Good Engineering Practice (GEP) Established engineering methods and standards that are applied throughout the project lifecycle to deliver appropriate cost-effective solutions ISPE Baseline Pharmaceutical Engineering Guide. Vol.5. Commissioning and Qualification. ISPE, 2001

GEP GXP GEP GXP Goals and Relation between GEP and GXP Delivering appropriate cost-effective solutions Safety, quality and efficacy of medicinal products GEP GXP

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

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

Critical Manufacturing System (Impact on Drug Quality) GEP and GMP Application to a Critical Manufacturing System GXP Regulatory Drug Quality GEP Engineering Effectiveness Critical Manufacturing System (Impact on Drug Quality)

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

Common Areas and Tools of GEP and GXP Quality Risk Assessment (RA/IA) User Requirements Specifications (URS) Design Reviews and Qualification (DR/DQ) Commissioning and Qualification of Equipment and Systems (FAT/SAT, IQ/OQ) Operation and Maintenance of Equipment Documentation System and Records Change Management Monitoring and Control Internal Audits Suppliers Management Continuous Improvement

ISO 9001 GXP ISO 14001 GEP Quality Management System GEP as a Management System Quality Management System ISO 9001 Pharmaceutical Quality System GXP Environmental Management System ISO 14001 Engineering Management System GEP

GEP as a Part of the General Compliance Management System Quality Management System ISO 9001 Pharmaceutical Management System GXP Environmental Management System ISO 14001 Engineering Management System GEP

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

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