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What is GMP? Parts of GMP – Quality Assurance – B.Pharmacy 6th Semester

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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