Process Flow Diagram for Assessment of Blend and Content Uniformity for Process Design and Process Qualification Batches
This flow diagram is recommended for the assessment of blend and content uniformity during the manufacture of batches corresponding to Stage 1: Process Design and Stage 2: Process Qualification. The sampling plans presented are meant to be examples. Alternative sampling plans may be used.
Process Flow Diagram for Assessment of Blend and Content Uniformity for Process Verification (Stage 3B) Batches
This flow diagram is recommended for the assessment of content uniformity during the manufacture of batches corresponding to Stage 3B: Process Verification. Additional blend and content uniformity samples may be required for Stage 3A: Process Verification, depending on the results process knowledge obtained during Stage 1 and Stage 2 testing. The sampling plans presented are meant to be examples. Alternative sampling plans may be used.
Common Acceptance Limit Tables For Sampling Plans 1 & 2 Based on ASTM E2709/E2810
Acceptance Limit Tables in pdf format are provided based on the ASTM E2709/E2810 methodology for Sampling Plans 1 (i.e., one dosage unit tested per location) and 2 (i.e., more than one dosage unit tested per location). All Acceptance Limit Tables were generated to provide at least a 95% probability that a sample from the batch will pass the USP UDU test. Sampling Plan 1 Acceptance Limit Tables with a 90% confidence level are provided for various sample sizes from 10 to 500. Two Acceptance Limit Tables based on a 50% confidence level for sample sizes of 10 & 30. Sampling Plan 2 tables with a 90% confidence level are provided for three sampling plans: 20x3, 20x7, and 40x3 (# locations x # tested per location).
Excel Workbook: Blend ASTM Final Dosage Units Calculations
This Excel workbook performs an analysis of blend and/or final dosage units. The user inputs the content uniformity data and the spreadsheet provides summary statistics and a data plot. A variance component analysis is also included for blends with three replicates per location or final dosage units based on either a 20x3, 20x7, 40x3 (# locations x # tested per location) sampling plan. For final dosage units, the spreadsheet also calculates the statistics required to apply ASTM E2709/E2810 methodology, looks up and provides the acceptance limits, and displays the final outcome of whether or not the sample meets the acceptance limits.
Version 01_02, updated 22 April 2018
Content Uniformity and Dissolution Acceptance Limit Program (CuDAL)
CuDAL is a set of programs written in SAS™ Version 8.02 that can be used to evaluate content uniformity and dissolution data against the current USP 29 tests. CuDAL was a statistical methodology prior to becoming an ASTM method. Using these programs will enable companies to determine if their work satisfies regulatory and/or company validation requirement.
Contents:
- Read me file
- SAS programs
- Users guide
- Validation Report
- Tables as PDFs for specific sample sizes