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Consulting

 

 

PARENTERAL PRODUCTS PRE-APPROVAL INSPECTIONS

 

 

PRE-APPROVAL

 

Qualification of Equipment Includes Computer Programs (autoclaves, ovens, lyophilizers)

Qualification of Filling Line Media Fills

Validation of Systems Related to Facility (WFI, HVAC, clean steam, nitrogen, compressed air, etc.)

Training Program

Validation of Sterilization of Equipment (parts, filling equipment, filters, tanks)

Computer Systems Hardware/Software

Laboratory Method Validation

Master Formula

Stability Pilot or Development Batches Made in Production Facility

Development Data

Oxygen Sensitivity

Closure Compatibility

Container

Physical Factors (extrusion force, particulate)

Preservative Effectiveness

Heat Sensitivity (autoclavability)

Metal/Light Sensitivity

Filter Compatibility and Integrity

Raw Data (for above)

 

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