GMP PPT
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Good Manufacturing Practices (GMP) are regulations for manufacturing drugs and medical devices to ensure quality and minimize risks. GMP describes methods, facilities, and controls for manufacturing. Following GMP helps reduce rejects and recalls, satisfy customers, protect company reputation, minimize contamination, eliminate errors, and produce consistent quality products. GMP covers requirements for facilities, warehousing, production, quality control, personnel, materials, equipment, quality assurance, packaging, distribution, and dealing with recalls and complaints.
GMP PPT
- 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 & pceutical 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