Standard (e.g. Ph.Int., BP, USP, in-house) Specification reference number and version Acceptance criteria Acceptance criteria Analytical procedure Test (release) (shelf-life) (type/source/version) Description Identification Impurities Assay etc. 2.3.P.5.2 Analytical Procedures Summary of the analytical procedures (e.g. key method parameters, conditions, system suitability testing): 2.3.P.5.3 Validation of Analytical Procedures Summary of the validation information (e.g. validation parameters and results): 2.3.P.5.4 Batch Analyses Description of the batches: Use (e.g. comparative Strength and Date and size bioavailability or biowaiver, number site of production stability) Summary of batch analyses release results for relevant batches (e.g. comparative bioavailability or biowaiver, stability): Acceptance Results Test criteria x> y> etc. Description Identification
Standard (e.g. Ph.Int., BP, USP, in-house) Specification reference number and version Test Acceptance criteria (release) Acceptance criteria (shelf-life) Analytical procedure (type/source/version) Description Identification Impurities Assay etc. 2.3.P.5.2 Analytical Procedures Summary of the analytical procedures (e.g. key method parameters, conditions, system suitability testing): 2.3.P.5.3 Validation of Analytical Procedures Summary of the validation information (e.g. validation parameters and results): 2.3.P.5.4 Batch Analyses Description of the batches: Strength and number size Date and site of production Use (e.g. comparative bioavailability or biowaiver, stability) Summary of batch analyses release results for relevant batches (e.g. comparative bioavailability or biowaiver, stability): Test Acceptance criteria Results x> y> etc. Description Identification
NAFDAC-QOS-PD26379.docx