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Synthetic Plant

QA / QC

Validation

  • Process
  • Cleaning
  • Method
  • Water
  • HVAC etc.

Personnel Qualification
(Training etc.)

Internal-Audit

Annual Product Review

Documentation
(Records and Reports)

  • Change control
  • Deviation Investigation
  • Failure Investigation
  • OOS
  • Complaints etc.

Calibration and Maintenance
of Laboratory Instruments

Laboratory Controls

Stability Program

cGMP

Prevention of Contamination
and Cross-contamination

System of Specified Environmental Conditions

Easy to Clean

Optimal Material, Personnel
and Waste Flow

Building Separation

Adequate Space

Stability Program