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

2. 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

3. 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

4. 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

5. 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.

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. 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)

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 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

10. 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

11. 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

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