Presentation on GMP

1. Submitted to : Mrs. Suchitra Mam
Submitted by : Himanshu (1216/18)
6th Sem.
HK Technical PGIMS – SDPGIPS Rohtak

2.  Good Manufacturing Practice is a set of
regulations , codes and guidelines for the
manufacture of drug substances and drug
products , medical devices and foods.
 Good Manufacturing Practices are regulations
that describe the methods, equipment,
facilities, and controls.
HK Technical PGIMS – SDPGIPS Rohtak

3. ➢ Reduce rejects, recalls.
➢ Satisfied customers.
➢ Company image and reputation
➢ To minimize contamination
➢ To eliminate error
➢ To produce product of consistent quality
HK Technical PGIMS – SDPGIPS Rohtak

4. HK Technical PGIMS – SDPGIPS Rohtak

5. 1. General requirements:
➢ Location and surroundings
➢ Building and premises
➢ Water system
2. Warehousing area
3. Production area
4. Quality control area
5. Personnel
6. Raw materials
7. Equipments
HK Technical PGIMS – SDPGIPS Rohtak

6. 8. Quality Assurance:
➢ To understand key issues in quality
assurance/quality control.
➢ To develop actions to resolve current
problems.
9. Quality Control System
10. Packaging Records
11. Distribution Records
12. Product Recalls
13. Complaints and Adverse Reactions
HK Technical PGIMS – SDPGIPS Rohtak

7. Area requirements Basic installation Ancillary Area
1. External preparations 30 sq. m 10 sq. m
2. Oral liquid
preparations
30 sq. m 10 sq. m
3. Tablets 80 sq. m 20 sq. m
4. Powders 30 sq. m -
5. Capsules 25 sq. m 10 sq. m
6. Surgical dressings 30 sq. m -
7. Ophthalmic
preparations
25 sq. m 10 sq. m
8. Pessaries &
suppositories
20 sq. m -
9. Repacking of drug &
p’ceutical chemicals
30 sq. m
HK Technical PGIMS – SDPGIPS Rohtak

8. 1. Organization :
➢ Lack of commitment
➢ Lack of resources
2. Layout and Construction :
➢ No quarantine area
➢ Cracked floor
3. Equipment :
➢ No calibration
➢ Rusty
➢ No performance check before use
4. Laboratory Testing :
➢ Poor reference standard keeping
➢ Poor data recording
HK Technical PGIMS – SDPGIPS Rohtak

9. 5. Documentation and Recording :
➢ No sign. and No countercheck
➢ No written procedures
➢ No document review
6. Labelling :
➢ Status not defined clearly
➢ Poor labelling control
7. Validation :
➢ Insufficient validation
➢ Insufficient raw data
HK Technical PGIMS – SDPGIPS Rohtak

10. HK Technical PGIMS – SDPGIPS Rohtak