Laboratory Quality and Regulatory Framework
Rigorous oversight ensuring reliable, compliant, and attributable analytical results.
Laboratory Quality and Regulatory Framework
Reliable analytical results depend on more than an instrument. They require an authorized scope, approved procedures, qualified equipment, trained personnel, attributable records, independent review, controlled investigations, data integrity safeguards, and effective document retention.
Uncompromising Standards
Data integrity & controlled oversight
Authorized Chemical Testing Scope
Drug testing is performed within the laboratory's current authorized scope for chemical testing.
Controlled Laboratory Operations
Our strict operational procedures govern every aspect of the testing lifecycle to guarantee quality and integrity.
Protocols & Methods
Approved methods, specifications, protocols, and forms rigorously followed.
Equipment Control
Equipment qualification, calibration, maintenance, and strict status control.
Training
Documented training and specific authorization for all assigned activities.
Sample Management
Sample receipt, precise identification, secure storage, handling, and chain of custody.
Material Controls
Reference standard, reagent, solution, column, and consumable controls.
Lifecycle & Archival
Review, approval, detailed reporting, secure archival, and retention.
Data Integrity
Laboratory records are expected to be attributable, legible, contemporaneous, original or a verified true copy, accurate, complete, consistent, enduring, and available.
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Access, audit trails, calculations, changes, and review are controlled according to applicable procedures and system capability.
Deviations and Investigations
Deviations, atypical results, out of specification results, and laboratory events are evaluated through documented procedures. Conclusions are strictly based on evidence and scientific assessment.
Retesting or resampling is not used to replace an original result without documented justification.
Collaborative Quality
Ensuring clear boundaries and shared commitment to regulatory excellence.
Client and Partner Oversight
Quality or technical agreements define responsibilities when appropriate.
Partner coordinated microbiology is disclosed, approved, and governed through:
- Qualification
- Contracts
- Quality oversight
- Data review
- Investigations
- Reporting
- Agreed responsibilities
Accelerate Your Analytical Testing
Get in touch with our experts to discuss your pharmaceutical analytical testing needs and ensure absolute compliance and quality.