Module 10 Slide 1 of 11 WHO - EDM

Basic Principles of GMP

Equipment

Part One, 12.1–12.11

Module 10 Slide 2 of 11 WHO - EDM

Equipment

Objectives To review the requirements for equipment

selection, design, use and maintenance

To discuss problems related to issues around selected items of equipment

Module 10 Slide 3 of 11 WHO - EDM

Equipment

Principle

Equipment must be

located designed constructed adapted maintained

to suit their intended use

Module 10 Slide 4 of 11 WHO - EDM

Equipment

Principle

Equipment layout and design must aim: to minimize risks of error to permit effective cleaning to permit effective maintenance

And to avoid: cross-contamination dust and dirt build-up any adverse effect on the quality of products

Equipment must be installed to: minimize risks of error minimize risks of contamination

Module 10 Slide 5 of 11 WHO - EDM

Part One,12.3–12.4

Equipment

Pipes and pipings Fixed pipework:

clearly labelled indicate contents direction of flow

Service pipings adequately marked non-interchangeable connections or adaptors

Dangerous gases and liquids

Module 10 Slide 6 of 11 WHO - EDM

Part One, 12.5

Equipment

Balances and Measuring Equipment Appropriate range

Precision

Available to: production quality control

Calibrated scheduled basis checks records maintained

Module 10 Slide 7 of 11 WHO - EDM

Part One, 12.6–12.8, 12.10–12.11

Equipment

Production equipment Design

easily and thoroughly cleaned scheduled basis

Location Maintenance

No hazard to the products suitable non-reactive materials non additive not absorptive

Defective equipment removed labelled

Module 10 Slide 8 of 11 WHO - EDM

Equipment

Control laboratory equipment

Equipment and instruments: suitable for the tests to be performed

Defective equipment removed labelled

Module 10 Slide 9 of 11 WHO - EDM

Part One, 12.7 and 12.9

Equipment

Washing and Cleaning Design promotes easy cleaning

On scheduled basis

Washing and cleaning equipment: Manual Automated (Clean in place (CIP), Steam in

place (SIP)) Not the source of contamination

Module 10 Slide 10 of 11 WHO - EDM

Equipment

Group Session For the given type of equipment

What would your concerns be in relation to the manufacture of products, when inspecting this particular piece of equipment?

What are the signs of poor practice in cleaning, operation and maintenance?

Module 10 Slide 11 of 11 WHO - EDM

Equipment

Possible Issues

Poor design Lack of safety Poor quality finishes Lack of cleaning Lack of maintenance No usage log or record Use of inappropriate weighing equipment Open-plan location of compressing machines