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
Slide 6 of 31
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
Slide 9 of 31
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
Slide 10 of 31
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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