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Basic Principles of GMP

Personnel,
Premises and
Equipment

Module 2

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Personnel
Objectives

To review general issues related to personnel

To review requirements for key personnel

To review the training of personnel

To consider some specific issues

Module 2

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Personnel
Principle

Establishment and maintenance of satisfactory


system of QA and manufacturing of products and
actives rely on people.

Must be sufficient qualified personnel to carry out


tasks

Individual responsibilities must be clearly


understood by individuals concerned

All personnel should be aware of the principles


of GMP that affect them

Module 2

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Personnel
General

Adequate number of qualified people with


practical experience

An individuals responsibilities should not be so


extensive as to present a risk to quality

Individual written job description

Organization Chart

No gaps or unexplained overlaps

Adequate authority to carry out responsibilities

Module 2

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Personnel
General

Individuals must receive training in GMP:


initial training
continuing training
including hygiene standards
[[

Motivated to
support the establishment
maintain high-quality standards

Prevent unauthorized access to production, storage,


quality control

Stop personnel who do not work in these areas using them


as passageways

Module 2

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Personnel
Key Personnel
Key personnel (which normally should be full-time)
positions include:

Head of Production

Head of Quality Control / Quality Assurance

Head of Sales and Distribution

Heads of Production and Quality Control / Quality


Assurance should be independent of each other

Each position should have clearly defined and written


responsibilities

Should have adequate qualifications and experience


related to the area handled.
Module 2

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Personnel
Training

Training, in accordance with a written programme for


all personnel whose duties take them into production; or
into control laboratories; and
for others whose activities could affect the quality of the
product

On induction and continuing


on theory and practice of GMP;
approved by either the head of Production or QC as
appropriate
training records should be kept
training before undertaking any new task

Module 2

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Personnel
Training

Staff in special areas


clean areas; or
working with highly active, toxic, infectious,
sensitizing materials

should be given specific training

The concept of QA and its understanding and


implementation should be fully discussed during
training

Module 2

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Personnel
Visitors or Untrained Personnel
Preferable not to take them in. If this is unavoidable,
for example GMP inspectors:

Must be given information in advance; particularly


about
personal hygiene; and
protective clothing requirements

Module 2

Must be accompanied and closely supervised at all


times

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Premises
Objectives
1)

To review general requirements

2)

To list key requirements for site choice

3)

To consider specific requirements for main areas

4)

To list major facilities required in a multifunction


site

Module 2

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Premises
General Requirements
Premises must be located, designed, constructed, adapted
and maintained for the operations:

Minimize risks of errors and cross-contamination

Permit effective cleaning

Permit effective maintenance

Minimize build-up of dirt and dust

Eliminate any adverse effects on quality

Premises must be located to minimize risks of crosscontamination; e.g. not located next to a malting factory
with high airborne levels of yeast
Module 2

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Premises
General Requirements

Geography, climate, noise and economic factors

Neighbours
What do they do?
What impact can they have on the business?

Pollution/effluent control

Facilitate sanitation.

Be maintained and cleaned easily

Services availability

Protection against entry of insects or other animals

Module 2

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Premises
General Requirements

Rest and refreshment rooms

Changing, washing and toilet areas

Maintenance workshops

Animal houses

Module 2

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Premises
Design Principles

Module 2

Process flow

Material flow

People flow

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Premises
Example of Materials and People Flow
Arrival of goods

Entrance for visitors


QC

Entrance for Workers Shipment of goods

Offices

Canteen
Gowning

Incoming
Flow
goods

Material
Corridor

Shipping

Corridor
Corridor
Raw
Clean
Materials
&
Packaging Weighing
Packaging
Storage

Zone:
Processing

Filling

Packaging Finished
Products
Storage

Controlled

Washing

Zone:
Zone:

Machine
Shop

Utilities and Services

Module 2

People Flow

Corridor
Waste Treatment

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Premises
Warehouse

Storage areas of sufficient capacity for :

Clean, dry and maintained within acceptable temperature limits

Area under cover, protection from heat, dirt, and rain

Areas clearly marked and access limited for quarantine status


good.

Sampling area with GMP standards

Segregated areas for rejected, recalled and returned materials

Separate areas for highly active, hazardous, narcotic materials

Printed materials storage


Module 2

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Premises
Weighing areas (Dispensing)

Control systems (access, gowning, movement)

Environmental controls, dust control

Segregation

Smooth, impervious, durable, easy to clean finishes

Cleaning

Documentation

Module 2

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Premises
General Requirements

Personnel rest areas/cafeterias/changing rooms


away from operating areas
prevention of cross-contamination
prevention of operators going outside in work clothes
provision of access control
prevention of visitors access to operating areas

Maintenance service areas


separated from production areas whenever possible

Waste disposal
Proper control over segregation and disposal

Module 2

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Premises
General Requirements

Finish of Floors, Walls and ceilings


Difficult but not impossible to get right
Smooth, impervious, hard-wearing, easy to
clean
Resistant to operations and materials in use
Windows not opening to the outside
Avoid sliding doors

Module 2

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Premises
General Requirements

Design to avoid cross-contamination


Segregated areas
Airlocks and pressure differentials
Treatment of recirculated air
Protective clothing
Effective cleaning procedures
Closed production systems
Residue testing
Status labelling
Suitable lighting level

Module 2

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Premises
Manufacturing and Packaging

Dedicated and self-contained facilities for :

Logical flows of materials and people

Adequacy of working space and orderly and


logical positioning of equipment

Interior surfaces smooth/crack-free/easy to clean

Pipework and other fittings sited to avoid recesses

Drain design:
equipped to prevent backflow
open channels avoided

Module 2

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Premises
Manufacturing and Packaging

Effective air handling to suit product


temperature
humidity
filtration
Monitoring

Specifically designed and laid out to avoid mix-ups and


cross-Contamination
Changing facilities to provide segregated access

Prevention of cross-contamination

Suitable lighting levels


Module 2

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Premises
In-Process and QC laboratories

Located separate from but near manufacturing


prevention of cross-contamination
separate biological , microbiological,
radioisotopic areas

Designed for the operations being carried out


suitable storage space

Module 2

Safety, Chemical handling, waste collection

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Equipment
Objectives

Module 2

To review the requirements for equipment


selection, design, use and maintenance

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Equipment
Principle

Equipment must be

located
designed
constructed
adapted
maintained

to suit their intended use

Equipment layout and design must aim:


to minimize risks of error
to permit effective cleaning
to permit effective maintenance

Module 2

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Equipment
Principle

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 including safety
minimize risks of contamination

Module 2

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Equipment
Pipes and pipings

Fixed pipework:
clearly labelled
indicate contents
direction of flow

Service pipings
adequately marked
non-interchangeable connections or adaptors

Module 2

Dangerous gases and liquids

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Equipment
Balances and Measuring Equipment

Appropriate range

Precision

Available to:
production
quality control

Calibrated
scheduled basis
checks
records maintained

Module 2

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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 2

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Equipment
Control laboratory equipment

Equipment and instruments:


suitable for the tests to be performed

Defective equipment
removed
labelled

Module 2

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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 2

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