Start from intended research use

Describe the experiment class, sensitivity to impurities, supplied form, fill, quantity and destination. The supplier can only scope methods and handling against a concrete decision.

  • Exact molecule or sequence
  • Salt/counter-ion or supplied form
  • Target fill and quantity
  • Required analytical packet
  • Destination and timing

Ask how the lot is released and changed

Request the release specification, responsible approval role, batch traceability, handling of deviations and how changes to process, method, raw materials or packaging are communicated.

Make commercial remedies testable

Third-party testing, refund or replacement language should name the laboratory, method, specification and sampling rule. Vague promises are difficult to enforce and difficult for either party to investigate.

Primary references

FDA Quality Systems Approach to Pharmaceutical CGMP