3. Quality Audits Master formula and batch production records. Specifications for the presence of unreacted intermediates and solvent residues in the
{"Image DocumentName": "3. Quality AuditsMaster formula and batch production records.", "Image ImageDescription": "\u2022 Specifications for the presence of unreacted intermediates and solvent residues in the finished excipient. \u2022 Storage areas for rejected products. adequacy of measures taken to preclude contamination of materials in the process. 4. Equipment - -Use of equipment - Equipment that contains tarry or gummy residues that cannot be removed easily should be dedicated for use with these products only. Cleaning programme - Detailed cleaning procedure - Sampling plan - Analytical methods/cleaning limits 5. Materials -Starting materials \u2013labile products. - Rejected and recovered materials - Returned excipients.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}