validation of dosages form introduction types advantages disadvantages validation of solution validation of solid dosages form

1. VALIDATION
PREPARED BY
AKASH
M. PHARMA 1ST SEM.
(PHARMACEUTICS)
IPS,KUK

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.

3. TYPES OF VALIDATION
 Prospective validation
 Concurrent validation
 Retrospective validation

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

9. VALIDATION OF SOLUTION
Equipment
critical
process
parameters
• Mixing speed
• Homogenizing
speed
• Mixing time
• Heating/cooling time
• Pumping speed

10. Critical
manufacturing
step
• Dissolving step
• Melting step
• Homogenizing
step

11. CRITICAL PROCESSING STEPS
Dissolved
active
ingredient
Filtration
pH
adjustment
Final
mixing

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