This guide is for business-to-business planning. Product availability, regulatory requirements and document acceptance must always be confirmed for the destination market.
Product specification and certificate of analysis
The specification defines tested attributes and acceptance criteria; the certificate reports results for a particular batch. Buyers should review both and confirm the relevant pharmacopoeial or in-house standard.
Manufacturing and quality credentials
Depending on the market, buyers may request manufacturing licences, GMP evidence, product permissions and quality-system information. Documents must be verified for validity, scope and issuing authority.
Stability and shelf-life support
Shelf life should be supported by an appropriate stability programme for the proposed formulation and pack. Zone requirements and documentation expectations differ between markets.
Market-specific registration support
A dossier, technical package or selected documents may be needed for registration. Availability is product- and partner-specific and should be agreed before commercial commitment.