GOOD ENGINEERING PRACTICE

Overview Course Objectives/Content

Over the last 10 years there has been a significant A broad overview of the history of the
change in the way pharmaceutical products are pharmaceutical industry in Western markets and
developed and manufactured, therefore we now then to describe the framework that evolved to
have a regulatory framework which is focussed on regulate the industry.
risk based pharmaceutical manufacture. Good
Engineering Practice (GEP) has been highlighted as To describe and explain the changing role of the
being an integral part of the quality system in engineering disciplines within the pharmaceutical
standards like ASTM E2500 along with risk industry with particular emphasis on the
management, design review, change management enhanced role of the engineer as described in
and continuous improvement. The approach to documents such as the ICH guidelines 9 and 10
verification of equipment and facilities is changing and ASTM E2500.
with many companies taking the opportunity to
redefine GEP in their QMS and their approach to Explore the role of Good Engineering Practice in
validation, to focus on critical activities and avoid relation to Good Manufacturing Practice (GMP)
unnecessary repetition of testing during lifecycle and investigate the strengths, weaknesses and
activities. applications of principles such as risk
management. The course material will be
Engineers from all disciplines play a key role in the enhanced with practical examples of the
development and manufacture of pharmaceutical applications of these principles.
products, with involvement in the specification,
design, verification and subsequent maintenance of Specific presentations will be given in the
the facilities, utilities and equipment necessary for traditional areas of engineering expertise
the various stages of production. There is now the including design and implementation of critical
opportunity for engineers to become Subject Matter utilities (water, clean steam, high quality air
Experts and take a lead role in risk based decision handling systems and compressed gases). Course
making throughout lifecycle activities and take a participants will be given an understanding of the
more prominent role during all stages of production basic microbiology important to the
and inspections. Pharmaceutical industry and this will be applied in
the context of the importance of bioburden
With this progression in GEP philosophy, and "system control for sterilisation methods such as filtration
experts" playing a much more significant role in and application of heat.
pharmaceutical processes and projects, never has
the need been greater for knowledgeable engineers The course will complete by illustrating the role of
to be an integrated part of all pharmaceutical the engineer in pharmaceutical quality
manufacturing and project processes. Based on management systems from project engineering
current "real world" experiences, this course will through operational management of quality and
highlight how current GMPs are applied to involvement in plant inspections.
pharmaceutical engineering and technical services
to ensure facilities, equipment and processes are
maintained to the correct standard as efficiently as
possible.

Who Should Attend

This course is suitable for both introductory training

and as a refresher course for engineers already
working in the pharmaceutical and related
healthcare environments.

Registered Address: Harmire Enterprise Park, Barnard Castle, County Durham, DL12 8BN, U.K.
Tel: +44 (0) 1833 690101 Fax: +44 (0) 1 833 690102 Email: enquiries@honeyman.co.uk Web: www.honeyman.co.uk
Registered in England and Wales No. 3308581
 GOOD ENGINEERING PRACTICE
Course Programme

Day 1

09:00 - 09:15 Course Introduction

09:15 - 09:45 09:15 - 09:45 History of the Pharmaceutical Industry in Europe and North America

09:45 - 10:15 Regulatory Framework and Enforcement

10.15 - 10.45 The Role of the Engineer (GEP vs GMP)

10:45 - 11:00 Tea/Coffee

11:00 - 12:00 Emerging Approach to GEP

12:00 - 13:00 Lunch

13:00 - 13:45 Contamination Control (API, Excipients, Components, Counterfeiting)

13.45 - 15.00 What Engineers Can Achieve - The Manufacturing Environment

15:00 - 15:15 Tea/Coffee

15:15 - 15:45 What Engineers Can Achieve - Critical Utilities

15.45 17.00 What Engineers Can Achieve - Water and Steam

Day 2

09:00 - 09:45 What Engineers Can Achieve - Compressed Gases

09:45 - 10:45 What Engineers Can Achieve - Bioburden Control and Sterilisation

10:45 - 11:00 Tea/Coffee

11:00 - 12:00 Control of the Operating Condition

12:00 - 13:00 Lunch

13:00 - 14:00 The Quality Management System

14:00 - 15:30 Process Engineering

15:30 - 15:45 Tea/Coffee

15:45 - 16:45 Change Control

16:15 - 16:30 Engineers and Inspections

Course Notes and Certificates

Full course notes and a certificate of attendance will be issued to each delegate who attends the full course. Certification is
for knowledge gained, not just attendance.

Registered Address: Harmire Enterprise Park, Barnard Castle, County Durham, DL12 8BN, U.K.
Tel: +44 (0) 1833 690101 Fax: +44 (0) 1 833 690102 Email: enquiries@honeyman.co.uk Web: www.honeyman.co.uk
Registered in England and Wales No. 3308581