Procedure for Redispersibility Testing in Suspensions
1) Purpose
The purpose of this SOP is to outline the procedure for evaluating the redispersibility of pharmaceutical suspensions after storage to ensure uniformity and quality.
2) Scope
This SOP applies to all pharmaceutical suspensions manufactured within the facility that require redispersibility testing as part of quality control.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting redispersibility testing and ensuring compliance with this SOP.
Production Department: Responsible for providing suspension samples and supporting QC during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples of suspensions from different batches.
4.1.2 Homogenize the suspension thoroughly using a suitable method to ensure uniform distribution.
4.1.3 Fill the suspension into appropriate containers for storage and testing.
4.2 Storage Conditions:
4.2.1 Store the filled containers under specified storage conditions (e.g., temperature, humidity) as per product stability requirements.
4.2.2 Document the storage duration and conditions accurately for each sample.
4.3 Redispersibility Testing:
4.3.1 Remove the suspension samples from storage and allow them to equilibrate to room temperature.
4.3.2 Invert the containers gently several times to resuspend the particles without introducing air bubbles.
4.3.3 Visually inspect the suspension for any signs of aggregation or clumping.
4.3.4 Evaluate the ease and completeness of redispersion qualitatively based on visual observation.
4.4 Quantitative Assessment (if applicable):
4.4.1 Use appropriate analytical methods (e.g., particle size analysis, turbidity measurement) for quantitative assessment of redispersibility.
4.4.2 Perform measurements according to validated procedures and compare results against predefined acceptance criteria.
4.5 Interpretation of Results:
4.5.1 Assess redispersibility results based on qualitative observations and quantitative data (if applicable).
4.5.2 Compare results against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.5.3 Document redispersibility testing results accurately, including any deviations from expected values.
4.5.4 Investigate and resolve discrepancies or out-of-specification results promptly.
4.6 Acceptance Criteria:
4.6.1 Suspensions are considered acceptable if they demonstrate satisfactory redispersibility without significant aggregation or sedimentation.
4.6.2 Ensure all redispersibility testing adheres to validated procedures and method validation parameters.
4.7 Documentation:
4.7.1 Record all redispersibility testing procedures, results, and observations in the Redispersibility Testing Report.
4.7.2 Maintain detailed records of sample details, storage conditions, testing conditions, equipment calibration, and any corrective actions taken.
4.7.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Redispersibility Testing Report
Storage Conditions Documentation
Sampling Plan Document
7) Reference, if any
USP General Chapter <905> – Uniformity of Dosage Units
Pharmacopeial standards for Redispersibility Testing in Suspensions
8) SOP Version
Version 1.0