cGMP NMR
Regulated NMR support for identity, purity, structure, composition, and solid-state or formulation questions where NMR evidence is appropriate.
cGMP analytical services for regulated pharmaceutical testing decisions.
This section summarizes Triclinic’s cGMP service pages for regulated NMR, XRPD, particle size, thermal analysis, Raman/FTIR, morphology, release testing, USP <901> asbestos in talc testing, compendial testing, and analytical-capability routing. The focus is controlled testing, documentation, and interpretation appropriate to the quality decision.
cGMP service areas
Use these pages when the analytical result may support release, stability, compendial compliance, raw-material control, method validation, method transfer, an investigation, or another regulated decision.
cGMP XRPD
Regulated XRPD testing for solid-form identity, phase control, crystallinity, compendial needs, release support, and stability decisions.
Particle Size Analysis
Particle-size methods and reporting for regulated material characterization, release, stability, and investigation support.
Thermal Analysis (TGA/DSC)
Regulated DSC and TGA testing for thermal events, water or solvent loss, melting behavior, crystallinity, and material comparison.
Raman / FTIR
Regulated vibrational spectroscopy for identity, material comparison, contamination, polymorph, and formulation-support questions.
Morphology
Regulated morphology and microscopy support for particle shape, crystal habit, foreign material, and lot-comparison questions.
Release Testing Services
Execution of controlled analytical testing to support release, specification, stability, CoA, and quality decisions.
USP 901 Asbestos in Talc Testing
USP <901> talc testing support using appropriate controlled methods and documentation for asbestos-related quality decisions.
Compendial Testing
Compendial method execution, verification, and reporting for pharmaceutical materials where monograph or chapter requirements apply.
Analytical Capabilities Hub
Routing page for regulated analytical capabilities and technique selection when the right test path is not yet fixed.
How to use this section
Start with the regulated decision and the method status. A release test, compendial execution, method validation, transfer package, and investigation require different documentation and review paths even when they use the same instrument.
Common Questions
Can the analysis be performed under cGMP?
Yes, when the method, sample type, matrix, documentation requirements, timing, and quality agreement fit the agreed regulated scope.
What should be provided before cGMP testing starts?
Provide the sample identity, lot information, method or monograph, intended use, specification or acceptance criteria, SDS, handling requirements, chain-of-custody needs, and quality expectations.
Which cGMP service page should I use?
Use the page that matches the technique or decision. If the technique is uncertain, start with release testing, compendial testing, or the analytical-capabilities routing page.
What records can be delivered?
Depending on scope, deliverables may include reviewed results, controlled raw data, reports or certificates, calculations, spectra, diffractograms, images, deviations or OOS documentation, and QA-reviewed records.
How should turnaround and release schedules be planned?
Turnaround depends on method readiness, sample receipt, testing duration, system suitability, investigation needs, data review, and QA approval. Release-critical schedules should be discussed before sample shipment so responsibilities, specifications, reporting, and approval timing are defined.
Discuss cGMP testing requirements
Send the sample type, intended use of the data, method or monograph if available, specification, matrix, timeline, and whether the work is cGMP, validation, transfer, stability, release, or investigation support.
