1. PROCESS VALIDATION - ACTUAL REGULATION, PERFORMING AND INSPECTION

2. Eurasian Economic Commission​​ decision № 77 new revision
Annex 15 harmonization with EMA regulation
Main idea: inclusion of the principles of ICH (Q8, Q9, Q10) in Annex 15.
ICH Q8 Pharmaceutical Development
ICH Q10 Pharmaceutical Quality System
ICH Q9 Quality Risk Management
Knowledge management
Design space
Risk-based approaches

3. Eurasian Economic Commission​​ decision № 77 new revision
Key changes in Annex 15:
Documentation
Qualification
Process and Cleaning Validation
New sections:
Ongoing Process Verification during Lifecycle
Verification of Transportation
Validation of Packaging
Qualification of Utilities
Validation of Test Methods
Planning and documentation for Qualification and Validation
Added information on the qualification stages
Major revision of the Process and Cleaning Validation sections

4. Manufacturing process validation
Cleaning Validation
Harmonization with Eurasian Economic Commission​​ decision № 19
Toxicological evaluation
Prospective validation
Traditional approach
Appropriate number of times
based on a risk assessment
Continuous Process Verification
Hybrid Approach
Concurrent validation
Where there is strong risk – benefit to the patient
Retrospective validation?
Not acceptable!

5. Deficiencies
There are no manufacturing process validation or cleaning validation.
There are no justification for concurrent process validation approach.
There are no justification for CPP’s.
The evaluation of the risk to quality is not based on scientific knowledge, experience with the process.
Cleaning validation was performed with out toxicological evaluation.

6. Deficiencies
Cleaning validation was performed with out microbiological or bacterial endotoxins consideration.
There are no drug product testing results in manufacturing process validation report.
Less than three consecutive batches were manufactured during manufacturing process validation.
There are no results for few acceptance criteria mentioned in validation protocol.

7. Thank you!
QUESTIONS PLEASE!