Identify critical and special processes, establish validation checklist and specify processes and items requiring validation.
Optimization of Validation Parameters
Guidance on the formulation and implementation of validation protocols for critical processes (ultrasonic cleaning, sealing, etc.) to optimize validation parameters.
Ensure Compliance with Regulatory and Standard Requirements
Guidance on preparation and implementation of validation protocols for special processes (sterilization) to meet regulatory and standard requirements.
Optimization of Pilot Production Plan
Rational planning for three batches of pilot production (first batch for process feasibility, second batch for sterilization and packaging validation, third batch for formal validation) to ensure sufficient validation data for registration submission.
Recommendations on Packaging and Transportation Validation Protocols
Recommendations on packaging validation (leakage test, aging test) and transportation validation protocols.
