CONTROLS DEFINED
•Data from material and product testing used to identify critical quality and process attributes for pack and packaging process, e.g.:
•Need for RH controls during packing
•Need to inert gassing of pack headspace
•Seal integrity testing
•Need for extractable testing as a routine control
•Manufacturing controls/specifications for the pack components and suppliers, eg, dimensional and performance specifications, need for clean room manufacture etc
•Manufacturing controls for the packaging process