1. Sterile product validation

2. Contain Defination Pre-validation Requirements Validation team
Procedure of sterile product validation
Validation protocol
Validation Batch
Validation Report
Revalidation
References

3. Process validation
Process validation is establishing documented evidence, which provide high degree of assurance that specific process will its predetermined specification and quality characteristics.

4. Types of process validation
Prospective :- premarket validation
Concurent :- based on imformation generate during actual in process
Retrospective:- based on testing and control data

5. Defination Sterile Product :
The Products which free of any viable organisms.
Sterility :
Viable microorganisms are absent.

6. Terminal Sterilization :
Operation whereby the product is sterilized separately by Autoclave
Aseptic Operation:
Operation whereby the product is sterilized separately by filtering
through 0.2 μ or less filter

7. Pre-validation Requirements
Maintenance of Facilities and Utilities
Calibration of Equipment
Cleaning Validation
Equipment Qualification
Raw Materials/Test Methods
Change Control
Training operators
before the process can be validated

8. Validation Team: Procedure sterile product vlidation
Validation Team: Production, QC, QA, Engineer,Planner
Procedure sterile product vlidation
To prepare the validation protocol
Verify the calibration and maintenance status of equipment
Perform qualification of equipment
Verify change control
Schedule the validation activities

9. Cont……. Training production operators Conduct validation study
Assure that the approved testing standard is being used
Evaluate all test results.
Prepare the validation report.

10. Validation Protocol
A document stating how validation will be conducted,
including test parameters, product characteristics, production
equipment to be used and decision points on what
acceptable test results

11. Validation Protocol should contain
Title Page
Purpose of validation
Equipment List
Ingredients and Component List
Process Flow Diagram and Description
Acceptance Criteria
Process for evaluation
conclusion

12. Equipment Critical Process Parameter:
Mixing Speed
Mixing Time
Type and size of filter
Filtering Time and Pressure used
Filling Speed
Temperature Terminal Sterilization

13. Critical Processing Steps
Dissolved Active Ingredient
pH Adjustment
Final Mixing
Filtration
Filling
Sterilization
Leak test

14. Critical processing step Acceptance criteria
Dissolved Active Ingredient
Clear Solution
pH Adjustment
pH with in specification
Final Mixing
pH, Appearance, Assay Content,
Filtration
Sterility, pH

15. Cont….. Filling Appearance Sterilization Sterility, Assay, pH etc.
Leak Test
No. of Leaked products
Visual Inspection
No. of Defected products

16. Validation Batch: Sampling and Testing 1 Samples may be taken by
Using a sampling device
2 Take at least 2 samples at top, middle and bottom
Individual Testing of sample must be done
3 testing standard specification

17. Finish Product Testing after Sterilization
a)Uniformity of filled volume Perform testing on filled containers. b)Visual Evaluation Appearance, Color of solution c)Other Testing Assay, pH, Pyrogen or Endotoxin etc.

18. Validation Report Validation Team must prepare the report
Report must be reviewed and approved by QA.
process validation must be issued to top management.
In case of failure, an investigation must be completed and documented
prior to repeat the validation study.

19. revalidation
Revalidation is not compulsory but may be needed in case of changes in formula composition or raw material source or manufacturing process or manufacturing location

20. References
Fundamentals of Quality Assurance Techniques, 1st edition, R. Sawant , S. Hapse , Career publication page no
Pharmaceutical Process Validation”; An international 3rd edition; edited by R. A. Nash and A. H. Wachter;
Pharmaceutical Quality Assurance ,Nirali publication edited by Prof. Manohar A. Potdar page no: