Why Documentation is required..?
ØTo define the method and control
ØTo prevent errors from spoken communication
This section covers
ØDocumentation System and Specifications
ØEquipment Cleaning and Use Record
ØRecords of Raw Materials, Intermediates, API Labeling and Packaging Materials
ØMaster Production Instructions
ØBatch Production Records (BPR)
ØLaboratory Control Records
ØBatch Record Review
