Specifications and Records for Supplier Evaluation
Quality Control and Product Documentation
XinChem coordinates product specifications, available batch documentation and customer-specific quality requirements with the relevant manufacturing and testing teams. The scope of testing and documentation is confirmed according to the product and agreed supply arrangement.
Quality Management Framework
We confirm specifications before supply and coordinate batch-specific CoAs, traceability information, and change-control or quality questions with the relevant teams.
Specification Review
Product identity, purity or assay requirements, test methods and other acceptance criteria should be confirmed before supply.
Batch Documentation
A batch-specific CoA can be requested as applicable. The required document format and additional data should be discussed before the order or project is finalized.
Traceability Information
Available batch identification and relevant manufacturing or packaging information are coordinated according to the supply arrangement and confidentiality requirements.
Changes and Quality Questions
Customers should notify XinChem of any additional qualification or change-control requirements before supply. Quality questions are reviewed with the relevant teams and supporting records, as available.
Analytical Support
Analytical methods and data are matched to product characteristics, customer specifications, and project requirements. Depending on the product and testing scope, support may include:
HPLC / GC
Purity, assay, volatile components, or residual-solvent testing, where applicable.
NMR (¹H, ¹³C)
Structural confirmation and identity assessment, as required.
LC-MS / GC-MS
Product identity confirmation or impurity characterization, depending on the analytical objective.
Chiral Purity
Enantiomeric purity analysis for products where stereochemical control is relevant.
Water Content / LOD
Water content or loss on drying testing, according to the applicable specification.
Elemental Analysis
Carbon, hydrogen, and nitrogen analysis, where required by the product specification.
Customer-specific testing: Additional analytical methods and acceptance criteria can be evaluated according to customer specifications and project needs.
Documentation We Provide
Documentation is selected to match the product type, project phase, destination market, and customer requirements. Availability and scope are confirmed for each product or project.
| Document Type | Purpose / Availability |
|---|---|
| Certificate of Analysis (CoA) | Batch-specific analytical results, including applicable identity, purity, and other specified test results. Provided according to the product and supply arrangement. |
| Safety Data Sheet (SDS) | Safety, handling, storage, and hazard information for supplied products, as applicable. |
| Product Specification / TDS | Product specifications, technical characteristics, and relevant handling or application information, as available. |
| Analytical Reports or Spectra | Supporting analytical reports or spectra, subject to product availability, project scope, and applicable confidentiality arrangements. |
| Batch and Packaging Information | Relevant batch identification, packaging details, and shipping information to support incoming inspection and material traceability. |
| Customer-Specific QC Reports | Additional test results or reporting formats evaluated according to agreed customer specifications and project requirements. |
Need a specific document package? Custom QC reports and additional technical documentation can be discussed on a project basis. Please share your required documents, test methods, and acceptance criteria when contacting our team.
Regulatory and Compliance Support
We work with customers to clarify quality documentation, confidentiality, and audit requirements early in the sourcing or custom manufacturing process.
ISO 9001
Quality management framework supporting structured processes and quality documentation.
Customer Audits
Customer quality audits and related information requests can be discussed and supported as required.
NDA Support
Non-disclosure agreements can be arranged before confidential technical information is exchanged.
Regulatory Documentation
Documentation needs for regulatory filing or other compliance purposes are evaluated on a case-by-case basis.
Quality Should Be Demonstrated, Not Just Claimed.
We believe quality should be demonstrated through appropriate analytical data, clear specifications, and relevant documentation. Every supplied product is supported by documentation appropriate to its product type and agreed supply requirements.
For custom projects, quality parameters and acceptance criteria are discussed upfront and confirmed through agreed testing and documentation before release, as applicable to the project.
This approach helps customers evaluate and qualify XinChem as a supplier, supports incoming quality inspection, and helps reduce the risk of rejected lots and supply interruptions.
Request Quality Information
Please specify the product, required documents, test methods and acceptance criteria.