Quality and Documentation

Our manufacturing partners run quality management systems aligned with ISO 9001 (general quality), ISO 13485 (medical devices and cell culture for clinical use), ISO 45001 (occupational health and safety), and ISO 14001 (environmental management). Specific certifications applicable to a given product or production run are documented on the Certificate of Analysis.

Distributors and resellers usually need documents they can pass on to their own customers. Which documents are available for a given product is confirmed in the quotation, so state your requirements at inquiry. Lot documents are supplied with the shipment where available. Where your customers need documents in a particular format or language, say so and we will confirm what can be done.

Production lots are tested for the quality parameters relevant to the product type, such as sterility, endotoxin, pH and osmolality, cell-growth performance where the product is workflow-specific, and mycoplasma where applicable. Product-specific parameters and limits are stated in the lot documents.

Most of our catalogue is supplied for research and manufacturing use. We do not make blanket GMP, clinical or regulatory claims on this site. Where a customer's program needs a specific grade or document set, tell us at inquiry and we will confirm, product by product, what is available before you commit.

For private-label and custom formulations, specifications, label content and documents are agreed in writing before production. Projects start with a brief on the private label and custom media page.