Quality Assurance
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Precision, Compliance, and Partnership in Bulk Phytochemical Supply
Quality assurance at Chemesis is an integrated system, not a final checkpoint. It is embedded in every phase of our operation, from initial sourcing to final shipment. Our protocols are designed to deliver not only high-purity materials but also the transparent, defensible data required for rigorous research environments and compliance reviews.
The Chemesis Quality Standard
The Chemesis Standard is a comprehensive framework that defines our commitment to excellence. It is built on the principles of prevention, consistency, and verification, ensuring that every batch of material meets predefined specifications for identity, purity, strength, and composition before release.
Analytical Testing Protocols
We employ a suite of orthogonal analytical techniques to characterize each batch definitively. Core methodologies include:
- High-Performance Liquid Chromatography (HPLC/UHPLC): For purity assessment and quantitative analysis.
- Gas Chromatography-Mass Spectrometry (GC-MS): For volatile compound profiling and confirmation.
- Nuclear Magnetic Resonance (NMR) Spectroscopy: For definitive structural elucidation and identity confirmation.
- Mass Spectrometry (MS): For molecular weight confirmation and impurity profiling.
All methods are validated for their intended use and performed under strict procedural controls.
Multi-Stage Verification Process
Quality is verified at multiple critical control points
Incoming Raw Material Assessment
Identity and quality verification of botanical or precursor materials.
In-Process Testing
Monitoring of critical parameters during extraction, purification, and formulation stages.
Finished Product Release
Full battery of identity, purity, assay, and impurity profile tests against specifications.
Stability Monitoring
Ongoing studies under defined storage conditions to establish retest dates and shelf-life.
Documentation & Traceability
Complete traceability is mandatory. Every batch is supported by a comprehensive documentation package, which includes:
- Batch Production Records: Detailed account of the entire manufacturing process.
- Certificate of Analysis (COA): Batch-specific results from all release testing.
- Material Safety Data Sheet (MSDS): Standardized safety and handling information.
- Chain of Custody Documentation: Records tracking material from receipt to shipment.
Continuous Improvement
Our Quality System is dynamic. It incorporates:
- Corrective and Preventive Actions (CAPA): Systematic investigation and resolution of deviations.
- Change Control Management: Formal assessment of any proposed changes to processes, equipment, or materials.
- Internal Audits: Regular reviews to ensure adherence to written procedures and identify opportunities for enhancement.
Facility & Environmental Controls
Our processing and laboratory environments are designed to prevent contamination and mix-up. Controls include segregated material flow, dedicated equipment, monitored environmental conditions (temperature, humidity), and rigorous cleaning validation protocols to ensure cross-batch integrity.
Quality Certifications & Commitments
While we do not make claims of certification for marketing purposes, our operational philosophy is aligned with the principles of current Good Manufacturing Practices (cGMP) and relevant ISO quality management standards. Our primary commitment is to the scientific validity and regulatory appropriateness of our data and processes.
Partnering with Your QC Team
We recognize that our quality data integrates directly into your quality systems. We are structured to support your team with:
- Technical Documentation: Providing detailed method summaries and validation data upon request for audit purposes.
- Investigation Support: Assisting with anomalous results or analytical inquiries related to supplied materials.
- Data Integrity: Ensuring all provided documentation is accurate, complete, and attributable.
Contact Quality Assurance
For specific technical discussions regarding analytical methods, documentation requests, or quality-related inquiries, please contact our Quality Assurance department directly through the main contact channels, specifying the nature of your quality query.