2. VALIDATION
Validation is defined as the documented act of
demonstrating that a procedure, process, and
activity will consistently lead to the expected
results.
Validation is a requirement for Good Manufacturing
Practices and other regulatory requirements.
4. PROSPECTIVE VALIDATION
Concluded prior to market the product.
Experiment should be planned and documented.
Equipment, production environment and the
analytical testing methods should be validated.
Historical data is not available or insufficient and in-
process and finished product testing are not
adequate to ensure reproducibility.
5. CONCURRENT VALIDATION
Based on information generated during actual
implementation of the process
Risk of having to modify process parameters or
specifications over a period of time
Verifies the quality characteristics of a particular
batch and provides assurance that the same quality
would be attained again when subsequent batches
are manufactured.
6. RETROSPECTIVE VALIDATION
Based on accumulated historical production, testing
and control data.
Generally requires data from 10-30 batches.
Use data only from batches made by same
process.
Historical data is sufficient and readily available.
7. REVALIDATION
Provides that changes in a process and/or the
process environment introduced either
intentionally/unintentionally, do not adversely affect
process characteristics and product quality
8. VALIDATION TEAM
Production, QC, QA and Engineer planner to
Prepare the validation protocol
Verify the calibration and maintenance status of
equipment
Verify change control
Schedule the validation activities
Conduct validation study
Monitor critical steps
Evaluate all test results
Prepare validation report
12. ACCEPTANCE CRITERIA
Dissolved active ingredient Clear solution
Filtration No residue on filter
pH adjustment pH within specification
13. FINAL PRODUCT TESTING
Net content
Microbial testing
Content uniformity
Other testing
Assay
Viscosity
Preservative
Content
14. VALIDATION OF SOLID DOSAGE FORM
Step 1st :-
Validation of raw material both active ingredient and
excipients.
Particle size
Drug morphology
Surface area
Color
Other characteristics which important in assessing drug
availability and reproducibility.
e.g. water in sol. drug in order to achieve the
rapid dissolution/in-vitro availability milled/micronized to achieve
desired particle size range.
15. Particle size directly inter related to several key
processing variable
Flow blend uniformity
Granulation
Solution binder uptake
Compressibility
Lubricant efficacy
16. STEP 2ND :-
Volume of granulating solution/binder:
Greater volume of granulating agent needed to wet a
powder bed of finely divided particles then coarser
particle of same substance.
If particle size to surface area ratio is not controlled
and specific amount of granulation solution not stated
then wet mass will be over wet and problems of
hardening and insufficient dried product occurs.
17. ANALYTICAL METHOD VALIDATION
Criteria assessed prior to beginning any validation
program
Accuracy of method
Precision of method
In day/ out of day validation
Between operator variation
Between instrument variation
Between lab variation
18. TEST REQUIRED FOR SOLID DOSAGE FORM IN
PROCESS VALIDATION
Moisture content
Content uniformity of blend and final dosage form
Hardness
Disintegration and dissolution
Friability
Weight variation throughout batch sampling
Granulation particle size distribution