Quality and Certificates Policy

Westbrook Bioscience LLC · All policies

This policy explains the rules and practices that apply to Westbrook's website and organizational research-material services. It should be read together with the other Westbrook website policies.

Lot release and specifications

Westbrook releases a lot only under its documented process and against the specification identified for that product and lot. Product pages and certificates must distinguish specifications, tested results, informational data, and attributes that were not tested. A specification or certificate does not establish suitability for every laboratory method or application.

Understanding analytical results

Each reported result is limited to the stated sample, method, conditions, and attribute. A chromatographic area percentage is not automatically an assay of absolute content and does not, by itself, establish identity, molecular mass, counterion, residual solvents, water content, sterility, endotoxin, biological potency, or clinical quality. Only expressly reported attributes were tested or certified.

Certificates of analysis

A certificate should identify the product, unique lot, relevant methods, specifications or acceptance criteria where applicable, actual results, disposition, issue date, and authorization. The purchaser should verify that the label and certificate lot numbers match and should report a mismatch before use. Westbrook may correct an administrative or analytical error through a version-controlled process; superseded documents should not be relied upon.

No implied grade or approval

Unless a future product-specific program is lawfully established and expressly documented, Westbrook does not represent products as sterile, injectable, pharmaceutical grade, clinical grade, suitable for compounding, made under drug current good manufacturing practice, FDA approved, or certified reference materials. Descriptions such as high purity, premium, tested, or verified must not appear unless defined and substantiated for the stated attribute.

Purchaser qualification

The purchaser remains responsible for determining whether a product and its documentation are suitable for the purchaser's permitted nonclinical work, qualifying suppliers and methods in its system, and performing any additional testing required by its protocol, institution, or law. Questions about a certificate may be sent to [email protected] with the product and lot.

Sampling and Measurement Uncertainty

A certificate reports results for the tested sample under the identified method. Sampling, preparation, instrument performance, reference materials, calculations, and method capability affect interpretation. Numerical precision should not be read as greater certainty than the method supports.

Third Party Testing

When Westbrook uses an external laboratory, the certificate should identify the relationship accurately and should not imply that an outside laboratory approved the product or Westbrook. Westbrook remains responsible for reviewing the report and deciding whether the lot meets its released specification.

Document Authenticity

Certificates should be obtained from Westbrook's approved document channel and matched to the container lot. Alteration, selective removal, combination with another lot, or presentation of a certificate as evidence of an untested attribute is prohibited.

Policy Administration

Westbrook may revise this policy prospectively when its website, products, controls, or legal obligations change. The effective date identifies the current version. Questions about this policy may be sent to [email protected]. This policy does not authorize a product, transaction, or use prohibited by law or another Westbrook policy.

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