WELCOME
BASICS OF cGMP
1
Introduction
1. What is cGMP?
2. Why we need to know about cGMP ?
3. What are the objectives of our organization?
4. What are our most important assets?
5. What is our Social Responsibility
2
Suggested list of Topics
[Link] cGMP Related Topic
1. Premises
2. Personnel
3. Hygienic Behaviour
4. Causes of Cross contamination and its prevention
5. Equipments and Utilities
6. Materials & Warehousing
7. Active Pharmaceutical Ingredients
8. Documentation
9. Quality Management
10. Basics of Validation
11. Self Inspection
12. Complaints & Recalls
13. GMP inspections & Preparation for Inspection. etc 3
PREMISES
Design & Administration
K.P. Bhat
4
Objectives of this session
1. Making choice of site
2. To review general requirements of Premises
3. To consider specific requirements for main
areas
4. To list major ancillary areas required in a
multifunction Unit
5
Design Considerations
1. Effective cleaning
2. Effective maintenance
3. Minimize build-up of dirt and dust
4. Minimize risks of errors and cross-contamination
5. Eliminate any adverse effects on quality of products manufactured
6
Issues of Importance to select Location
Geography, climate, noise and economic factors
Neighbouring companies
Risks of cross-contamination.
7
Role of premises
Prevention of Cross-contamination
The Manufacturing area should be so designed to prevent
cross contamination. It should ideally have…
1. Segregated areas
2. Airlocks and pressure differentials
3. Treatment of recirculated air
4. Closed production systems
8
Ideal Premises
Easy Cleaning & Sanitization
Maintained and cleaned easily
Services availability
Protection against entry of insects or other animals
9
Ancillary Areas
Administration/Office area,
Quality Testing Laboratory
Rest and refreshment rooms
Changing, washing and toilet areas
Maintenance workshops
10
Design Parameters
Three basic factors to be considered
in the pharmaceutical plant design
are…
1. Process flow
2. Material flow
3. Personnel flow
11
General Requirement - Floors, Walls and
ceilings
Finish of Floors, Walls and Ceilings
Smooth, impervious, hard-wearing, easy to clean
Resistant to operations and materials in use
Windows not opening to the outside
Doors designed for ease of operation and cleaning
12
Warehousing
Warehousing area shall be
Designed for prevention of cross-
contamination and mix ups
Areas required
Material Receiving areas.
Storage areas of sufficient capacity
for Raw Materials, Packing
materials, and finished goods.
Separate areas for storage of
Quarantine, Under test and
Released materials.
Segregated area for sampling of
materials.
Separate area for the storage of
Rejected/ Recalled and returned
materials.
13
Warehousing
Separate areas for highly active, hazardous, narcotic materials
Separate material storage areas for materials requiring storage at low temperatures
Segregated areas for issue of materials to user departments.
Printed packaging materials storage
Areas Clean, dry and maintained within acceptable temperature limits
Area under cover, protection from heat, dirt, and rain
Smooth, impervious, durable, easy to clean finishes
14
Weighing/Dispensing areas
Should have Control systems for controlling
Environmental conditions (Temp/RH) and dust control
Should permit Segregation
Facility for Documentation
Area for storage of materials to be issued and the issued
materials
15
Manufacturing and Packaging areas
Designed and laid out to avoid mix-ups and cross-contamination
Designed to avoid damage to the surfaces of walls/ceilings during
material movement, and cleaning.
Changing facilities to provide segregated access
16
Manufacturing and Packaging areas
Dedicated and self-contained facilities to ensure
Logical flows of materials and people
Adequacy of working space
Orderly and logical positioning of equipment
Availability of Suitable lighting levels
17
Control of Noise Levels
Utilities and services inside
manufacturing areas
1. Pipe work and other fittings sited to avoid recesses (Material
deposit)
2. Steam and other hot lines insulated
3. Drain design:
Equipped to prevent backflow
Open channels avoided
4. Effective air handling to suit product
Temperature
Humidity
Filtration
5. Safety : Safety Mechanisms for protection against Fire/Tremors
and accidents.
18
Other Areas -Quality Testing Laboratories
1. Located separately but near manufacturing plant
2. Designed to prevention of cross-contamination and mix ups
3. separate Chemical , microbiological, and other specialized areas if required
4. Area designed to protect sensitive instruments from damage due to vibration,
5. humidity etc,
6. suitable storage space for laboratory reagents and other ancillaries
19
Other Areas- Canteen/Change Rooms
Canteen/change rooms to be designed and located with aim of
Prevention of cross-contamination
Prevention of operators going outside in work clothes/Factory Uniform
To Ensure access control
prevention of visitors or unauthorized person access to operating areas
20
Other Areas – Engineering & Utilities
Maintenance and service areas
Separated from production areas whenever possible
Designed to avoid generation and propagation of
contaminants. 21
THANK YOU
22
