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Regulatory History

Audited cGMP compliance across four decades

Zero FDA Form 483 observations and continuous EMA certification supporting commercial sterile injectables and complex clinical batches.

0

Form 483 Observations

40+

Years Continuous GMP

100%

Audit Pass Rate

Verification Metrics

Quantitative audit performance indicators

21 CFR

Part 11 Electronic Records

< 14 Days

Analytical Release Cycle

99.8%

Batch Acceptance Rate

ISO 5

Aseptic Cleanroom Standard

Quality Systems

Core compliance frameworks

Engineered for immediate regulatory submission and uncompromising batch integrity.

Monitoring
Batch Release
Assurance

Continuous Environmental Monitoring

Electronic Batch Release

Sterility Assurance Levels

Real-time particle and microbial tracking across all ISO Class 5 isolator units with automated data logging.

Fully integrated digital audit trails structured to eliminate post-run forensic cleanup and review delays.

Validated media fills and fractional cycle analysis ensuring robust terminal sterilization and aseptic controls.

Regulatory Philosophy

Our batch records are structured for immediate regulatory submission, not post-run forensic cleanup.

Director of Quality Assurance, Hettich Pharmaceutical

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