Pillar 01
Batch traceability
Every dispatched vial is linked to a production batch record covering source materials, processing steps, in-process checks and release testing. Traceability is preserved from raw input to end-user consignment.
Quality Assurance
A quality framework built around traceability and analytical evidence.
Our quality systems are designed to give laboratories the analytical, procedural and documentary evidence required for reference comparison, method development and internal QA.
Pillar 02
Identity testing
Identity is confirmed by methods appropriate to the material class — spectroscopic (FT-IR, NMR), chromatographic (HPLC, GC) or mass spectrometric — with results reported on the Certificate of Analysis.
Pillar 03
Purity testing
Purity is assessed against defined specifications using orthogonal analytical techniques. Related substances, residual solvents, water content and inorganic residues are evaluated as applicable.
Pillar 04
Third-party analytical verification
Selected catalogue items — including reference materials — undergo independent verification at accredited external laboratories. Third-party reports are archived and available on request.
Pillar 05
Manufacturing documentation
Master batch records, method files, analytical procedures and specification sheets are maintained under version control with defined review cycles and authorisation workflows.
Pillar 06
Document retention
Quality records, analytical raw data and batch documentation are retained for a minimum of 24 months from dispatch, with longer retention applied to reference standards.
Process
Specifications
Product specifications are established from a combination of pharmacopoeial references, method development studies and internal characterisation of primary reference lots.
Process
Change control
Modifications to specifications, methods or supplier arrangements are managed through documented change control with impact assessment and re-qualification where required.
Process
Complaints & CAPA
Customer notifications are logged, investigated and closed under a corrective and preventive action process, with root-cause analysis retained on file.