Guide 01 · Documentation
How to read a certificate of analysis
A certificate is useful only when it identifies the material and batch being assessed. First compare the product name, catalogue identifier, batch or lot number and test date with the proposed supply. Then read each result beside its stated specification and method; a result without an acceptance criterion or identifiable method gives procurement less context.
- IdentityMatch the named material, code and batch to the quotation and label.
- SpecificationSeparate the acceptance criterion from the measured result.
- MethodRecord how identity, assay or purity was evaluated and whether the method is suitable for its intended purpose.
- AuthorisationCheck the issue date, version and responsible issuer; resolve alterations or missing pages.
- RelationshipConfirm that any chromatogram, mass spectrum or supporting record belongs to the same batch.
Primary guidance: ICH Q7 covers certificates of analysis and documentation; ICH Q2(R2) explains validation of analytical procedures. Read ICH Q7 · Read ICH Q2(R2)
Guide 02 · Qualification
Peptide supplier qualification checklist
Qualification should be proportionate to the material, intended context and destination. Ask for evidence rather than accepting a general quality statement, and record which party is responsible for manufacture, testing, release, storage, export and complaint handling.
- Identity
- Legal name, trading address, manufacturing and testing locations, and the contracting party.
- Authorisation
- Licences or registrations claimed for the relevant activity and jurisdiction—checked with the issuing authority where applicable.
- Quality system
- Change, deviation, complaint, recall, record-control and supplier-management processes relevant to the requirement.
- Material control
- Specification, test methods, batch traceability, storage conditions and document availability.
- Commercial control
- MOQ, lead time, quotation validity, incoterm, payment, inspection and exception handling in writing.
Primary guidance: ICH Q7 provides a recognised framework for API documentation, materials management, laboratory controls and supplier-related quality responsibilities. View ICH quality guidelines
Guide 03 · Logistics
Planning a temperature-sensitive shipment
Begin with a documented target range and stability basis. The shipment plan should then define the packaging system, conditioning method, route, seasonal risk, monitoring device, handover points and an excursion process. A “cold-chain” label alone does not show that the route is controlled.
- DefineTarget conditions, allowed duration and evidence supporting them.
- QualifyPackaging and equipment for the route, load and seasonal conditions.
- MonitorLogger position, calibration status, activation and access to the record.
- ReceiveNamed consignee, prompt inspection and storage on arrival.
- EscalateQuarantine, evidence collection and a documented decision after any excursion.
Primary guidance: MHRA guidance describes risk assessment, defined responsibilities, suitable packaging, temperature monitoring and agreed exception handling for medicine distribution. Apply the rules that govern the actual material and supply route. Read MHRA GMP/GDP guidance · Read MHRA air-freight guidance
Guide 04 · Common terms
Procurement glossary
- CoA
- Certificate of analysis: a document reporting results for an identified batch against stated tests or specifications.
- Specification
- Documented tests, methods or references and acceptance criteria for a material.
- SDS
- Safety data sheet: hazard and safe-handling information; it supports, but does not replace, the buyer’s risk assessment.
- MOQ
- Minimum order quantity accepted for a particular quotation or supply arrangement.
- Lead time
- The agreed period to a defined milestone; clarify whether it ends at manufacture, release, dispatch or delivery.
- Incoterm
- An agreed trade term allocating specified delivery tasks, costs and risks; it does not replace the full contract.
- Excursion
- A recorded departure from defined storage or transport conditions requiring documented assessment.
Primary guidance: HSE explains the role of safety data sheets in workplace chemical risk assessment under UK REACH. Read HSE SDS guidance