Before the product reaches to customer, how the quality is reviewed is given in short.

1. Quality Review
Presentation by
Miss Utkarsha Sukhdev Shivsharan
M.Pharm (Quality Assurance)
Assistant Professor
DSTSM’s College of Pharmacy, Solapur

2. Quality Review
Process of reviewing all specifications
at all in-process check points are met
and all documentation with
signatures are incorporated in Batch
record

3. Specific procedures to be checked :
1. Foreign matter in production area
2. Correct amounts of correct ingredients and their correct
addition
3. Separation of one lot from others
4. Maintenance of specific storage conditions
5. Cleaning of containers and equipments before use and after
fourth cycle
6. Covering of equipments in production
7. Storing production equipments on rack
8. Personnel ready for task
9. Production meeting with specifications
10. Clean production area
11. Safety procedures
12. Dust control equipments
13. Supplying sealed containers until production begins and
removed after emptying
14. Sterile manufacturing guidelines are followed

4. Review of records
Material Records
Production records
In process records
Laboratory records
Stability testing of Finished
products

5. 4M concept
Material
Method
Machinery
Men