Current Good Manufacturing Practice

1. cGMP
Name-Jitesh Rajendra Batra.
Roll no-102.
Department-Pharmaceutics.
Subject-Pharmaceutical Plant Design &
Operation.
Guide-Mr.V.Nikam.
College-Amrutvahini College of Pharmacy,
Sangamner.

2. Content
● What is GMP?
● What is cGMP?
● Parts of cGMP

3. What is GMP?
● A set of principles and procedures which, when
followed by manufacturers for therapeutic
goods, helps ensure that the products
manufactured will have the required quality.

4. What is cGMP?
● Current Good Manufacturing Practice
regulations enforced by the US Food and Drug
Administration (FDA).
● There is the current practice which is going on
regularly in the plant shuld maintain precautions
and shuld follow all the rules and regulation
maid by the GMP.

5. Parts of cGMP
1. General
2. Building and Civil Works
3. Air Handling System (Central Air-Conditioning)
4. Environmental Monitoring
5. Garments
6. Sanitation
7. Equipment
8. Water and Steam Systems
9. Manufacturing Process
10. Product Containers and Closures
11. Documentation

6. 1. GENERAL-
Sterile products, being very critical and
sensitive in nature, a very high degree of
precautions, prevention and preparations are
needed to ensure aseptic conditions in all
areas.
2. BUILDING AND CIVIL WORKS-
Proper foundation is maintained to avoid any
cracks. The manufacturing area is separated
into different areas like,

7. ● Washing area.
● Component preparation area.
● Storage area.
● Preparation area – Blending Manufacturing
Area. Non aseptic Area etc.
3. AIR HANDLING SYSTEM (CENTRAL AIR-
CONDITIONING)-
Air Handling Units for sterile product
manufacturing areas shall be different from
those for other areas.

8. Critical areas, such as the aseptic filling area,
sterilized components unloading area and
change room conforming to Grades B, C and D
respectively shall have separate air handling
units.
Unless there are product specific requirements,
temperature and humidity in the aseptic areas
shall not exceed 27°C and relative humidity
55%, respectively.

9. 4. ENVIRONMENTAL MONITORING-
Particulate monitoring in air 6 Monthly
HEPA filter integrity testing
(smoke testing)
Yearly
Air change rates. 6 Monthly
Air pressure differentials Daily.
Temperature and humidity Daily.
Microbiological monitoring
by settle plates and/or
swabs
in aseptic areas
Daily.

10. 5) GARMENTS-
Only clean, sterilized and protective garments
shall be used at each work session where
aseptic filtration and filling operations are
undertaken.
The garments shall be made of non-shedding
and tight weave material.

11. 6) SANITATION-
This includes written procedures for sanitation
which is performed by trained employee.
Distilled water acquired from plant at 70°C or
alcohol or isopropyl alcohol may be used in
dilution of disinfectant.
Diluted disinfectants shall bear the label “use
before”, based on microbiological establishment
of the germicidal properties.
The solutions shall be adequately labeled and
documents maintained.

12. 7) EQUIPMENT-
It shuld only be treated as followed by the GMP.
In cGMP there is the testing of Quality is seen
in the on going process of manufacturing.
8) MANUFACTURING PROCESS-
Manufacture of sterile products shall be carried
out only in areas under defined conditions.

13. 9) Documentation-
(1) Serial number of the Batch Manufacturing
Record.
(2) Name of the product
(3) Reference to Master Formula Record.
(4) Batch/Lot number
(5) Batch/Lot size.
(6) Date of commencement of manufacture and
date of completion of manufacture.

14. (7) Date of manufacture and assigned date of
expiry.
(8) Date of each step in manufacturing.
(9) Names of all ingredients with the grade
given by the quality control department.
(10) Quality of all ingredients.
(11) Control reference numbers for all
ingredients.
(12) Time and duration of blending, mixing, etc.
whenever applicable.

15. (13) pH of solution whenever applicable.
(14) Filter integrity testing records
(15) Temperature and humidity records
whenever applicable
(16) Records of plate-counts whenever
applicable.
(17) Results of pyrogen and/or bacterial
endotoxin & toxicity.
(18) Results of weight or volume of drug filled in
containers.

16. Master Formula Records
There shall be master formula records relating
to all manufacturing procedures formula shall
include:-
● Name of the product.
● Proprietary name of the product along with the
generic name.
● Name, quantity, and reference number.

17. SOP
● Standard Operating Procedure shuld be
followed while manufacturing any of the product
which will help to maintain its quality.
● Quality Control and Quality Assurance
Department is there for inspection of all out
going product which not only be quality product
but it shuld maintain its quality

18. Thank
You