Standard Operating Procedure for Odor Testing in Gels
1) Purpose
The purpose of this SOP is to establish procedures for evaluating the odor of gel formulations to ensure product consistency and consumer acceptability.
2) Scope
This SOP applies to all personnel involved in odor testing of gel products within the pharmaceutical manufacturing facility.
3) Responsibilities
Quality Control (QC) Analyst: Perform odor testing according to this SOP.
Formulation Scientists: Provide input on odor characteristics and acceptable ranges.
Quality Assurance (QA) Team: Review and approve odor testing procedures and results.
4) Procedure
4.1 Sample Preparation
4.1.1 Prepare samples according to specified guidelines to ensure representative analysis.
4.1.2 Ensure samples are stored under appropriate conditions prior to testing.
4.2 Odor Evaluation
4.2.1 Conduct odor testing in a controlled environment free from interfering odors.
4.2.2 Use a panel of trained evaluators to assess the odor of the gel samples.
4.3 Testing Method
4.3.1 Follow a standardized protocol for sniffing and evaluating the samples.
4.3.2 Record descriptors and intensity ratings for each sample.
4.4 Data Collection and Analysis
4.4.1 Collect and compile data from the panel evaluations.
4.4.2 Analyze the data to determine if the odor of the samples is within acceptable limits.
4.5 Reporting and Documentation
4.5.1 Document odor testing procedures, results, and analysis comprehensively.
4.5.2 Maintain detailed records of odor testing for batch records and regulatory compliance.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
– Odor Testing Records
– Panel Training Records
– SOP for Sample Preparation and Handling
7) Reference, if any
– ASTM E1207-09: Standard Guide for Sensory Evaluation of Products by the Labeled Magnitude Scale
– ISO 8586:2012: Sensory Analysis—General Guidelines for the Selection, Training, and Monitoring of Selected Assessors and Expert Sensory Assessors
– Company-specific odor testing guidelines
8) SOP Version
Version 1.0
