it covers definitions of GMP, cGMp, objectives of cGMP, benefits, plant layout, equipment maintainance, etc.

1. Presented by:
Mahewash A. Pathan.
CGMP AND INDUSTRIAL
MANAGEMENT

2. GMP
“ GMP is a system for ensuring that the products
are consistently produced & controlled according to quality
standards”.
- it is designed to minimise the risks involved in any
pharmaceutical production that cannot be eliminated
through testing the final product. "

3. CGMP:-
“cGMP refers to current Good
Manufacturing Practices regulations enforced by
U.S. Food & Drug Administration. cGMP provides
a system that assure proper design, monitoring, &
control of manufacturing processes & facilities”.
 Announced by FDA in Aug 2002.
 FDA's cGMP practice steering committee.

4. OBJECTIVES & POLICIES OF CGMP
 ensure that products are consistently
manufactured and controlled to the specified
quality.
 concerned with all aspects of production and
quality control.
 In the manufacture of cosmetic products, overall
control and monitoring
 ensure that the consumer receives products of
specified quality.

5.  CFR, published by federal Gov, contains 50
chapters.
 Chapter 21 of CFR is for Food & Drug
manufacturing.
 Part 210 : cGMP in manufacturing, processing,
packaging, or holding of drugs.
 Part 211: cGMP for finished pharmaceuticals.
Part 211 is further divided into 11 subparts, A to K.

6. CGMP COVERS:
1. General consideration
2. Personnel
3. Premices
4. Equipment
5. Sanitation
6. SOP’s
7. Raw material
8. Self inspection and audits
9. MFR’s
10. BMR’s
11. Warehousing area
12. Labels and other printed material
13. QA

7. BENEFITS OF CGMP
 They outline a Quality system that reduces
errors.
 Ensures products are safe for use in humans.
 Minimizes variations in potency of drug.
 Prevent side effects.
 Prevent mislabeling and adultration.

8. LAYOUT OF BUILDINGS
 It is the organized properly planned
interdepartment and intradepartment
arrangement.
 Proper layout increases productivity and help
proper utilization of-
1. Man
2. Material
3. Money
4. Machines

9. IMPORTANCE OF PLANT LAYOUT
 It is long term commitment.
 It facilitates the production process, minimizes
material handling, time & cost,& allows flexibility of
operations .
 It facilitates easy production flow, makes economic
use of the builiding, promotes effective utilization of
manpower, & provides for employee’s
convenience, safety, comfort at work, maximum
exposure to natural light & ventilation.
 It affects the flow of material & processes, labour
efficiency, supervision & control, use of space &
expansion facilities.

10. Layout of buildings designed according to cGMP
which ensures
1. Prevention of cross contamination
2. Proper air handling system
3. Proper cleaning & sanitary conditions.
4. Proper lighting
5. Proper plumbing
6. Proper washing.

11. OBJECTIVES OF PLANT LAYOUT
 Proper & efficient utilization of available floor space.
 Provide enough production capacity.
 Reduce material handeling cost.
 Reduce hazard to personnel.
 Utilize labor efficiently.
 reduce accidents.
 Provide ease of supervision & control.
 Provide employee safety & health.
 Allow easy of maintainance.
 Better interdepartment relationship.

12. TYPES OF LAYOUT
1. Circular flow
2. Parallel flow
3. Crossover traffic

16. BUILDINGS & FACILITIES
A. Design and constructions
B. Floor
C. Roof system
D. Water
E. Containers
F. Lighting
G. Sewage and refuse
H. Sanitations and maintenance.

17. EQUIPMENT
 Should be selected based on the
intended use and cleanability.
 Must be placed in an appropriate
location.
 Must be properly qualified (design,
installation, operation, performance).
 Constructed so that, surfaces are non
reactive.
 Automatic, mechanical & electronic
equipments should be calibrated,
inspected or checked as per written
program to assure proper
performance.
 Computer input/output checked for
accuracy.

18. EQUIPMENT MAINTENANCE
 Weighing, measuring, testing &
recording equipment should be
serviced & calibrated regularly.
 All records should be maintained.
 Written procedures should include-
1. Responsibility for equipment cleaning
& maintenance.
2. Cleaning & sanitizing schedules.
3. Detailed description of cleaning.
4. Removal of previous batch
identification.
5. Protection of clean equipment
6. Inspection of equipment prior to use.