Presentation on GMP | Quality Assurance | B.Pharmacy 6th Semester
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
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
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
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
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
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
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
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