We manage the entire process from start to finish and provide an audit-ready validation/ qualification protocol and report with all supporting evidence, working with our Clients to show the desired parameters have been achieved.
11.4.1. The following should be validated as a minimum: (a) Warehouse premises: ambient and cold-chain storage conditions including temperature mapping; (b) Lagged containers; (c) Cold-chain processes; (d) Computerised systems; and (e) Transportation systems
18.104.22.168. (a) Packaging system of thermolabile pharmaceutical products, for purposes of distribution must be quality assured to ensure that it occurs within the cold room environment, fulfils the manufacturers’ specifications requirements, is thermally designed and validated, and is related to Temperature Profile(s)/Logistic history.