Development products

How ERP + Quality for Pharma is set up for you

Products with a Development market status still need a clear lot identity and a reviewed test record. A development team can use the same product, batch, specification, test result and release decision links as it uses for marketed products. The product record distinguishes market status; the batch records the actual manufacturing lot and its lifecycle.

Choose one Development product and a representative specification. Create a planned lot, then record the results that the quality team needs to assess. If a test outcome is Pass With Deviation, link an investigation to the batch and an action to that deviation. Record any relevant change to the product or specification through a change control. The release reviewer should see the current version label, the batch result and the change status when making a decision.

Agree how the team identifies a specification that applies to a given lot. Its effective date and version label are available for review, but the team must maintain them consistently. Rehearse both a Release and a Hold decision. Each decision should identify its reviewer and rationale. Mark only the reviewed Release lot Approved; the workflow posts every Approved batch. Check its later receipt against the lot that entered the release path.