Procedure for Granulation Size Distribution Analysis
1) Purpose
The purpose of this SOP is to outline the procedure for determining the size distribution of granules used in pharmaceutical manufacturing to ensure consistency and quality in the final product.
2) Scope
This SOP applies to all granulation batches prepared for tablet or capsule production within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting size distribution testing and ensuring compliance with this SOP.
Production Department: Responsible for providing granule samples for testing and maintaining granulation process parameters.
4) Procedure
4.1 Sampling:
4.1.1 Collect representative samples of granules from various points within the granulator according to the sampling plan.
4.1.2 Ensure samples are taken from different depths and locations to obtain a uniform representation.
4.2 Equipment Preparation:
4.2.1 Calibrate the sieving equipment as per the manufacturer’s instructions.
4.2.2 Ensure all sieves are clean and free from previous residues.
4.3 Sieving Procedure:
4.3.1 Weigh an appropriate amount of the granule sample (e.g., 100 grams).
4.3.2 Place the sample on the top sieve of a nested set of sieves arranged by decreasing mesh size.
4.3.3 Operate the sieve shaker for a specified period (e.g., 10 minutes) at a set amplitude.
4.3.4 After sieving, weigh the granules retained on each sieve and the pan.
4.4 Calculation:
4.4.1 Calculate the percentage of granules retained on each sieve.
4.4.2 Plot the granule size distribution curve to assess the distribution.
4.5 Acceptance Criteria:
4.5.1 The granulation is acceptable if the size distribution falls within the specified range (e.g., 20% retained on 30 mesh, 40% on 40 mesh, 30% on 60 mesh, 10% on pan).
4.6 Documentation:
4.6.1 Document all weights and calculations in the Granulation Size Distribution Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Granulation Size Distribution Record
Calibration Record for Sieving Equipment
Sampling Plan Document
7) Reference, if any
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0