SOP Guide for Pharma

SOP for Odor Testing in Creams

SOP for Odor Testing in Creams

Standard Operating Procedure for Odor Testing in Creams

1) Purpose

The purpose of this SOP is to outline the procedures for testing the odor of creams to ensure they meet sensory quality standards.

2) Scope

This SOP applies to all personnel involved in the quality control testing of creams, including laboratory technicians, sensory evaluators, and quality assurance (QA) personnel. It covers procedures for sample preparation, odor testing, and documentation.

3) Responsibilities

It is the responsibility of laboratory technicians to prepare and analyze samples, sensory evaluators to perform odor testing, and QA personnel to review and approve the test results.

4) Procedure

4.1 Preparation for Odor Testing

4.1.1 Review the batch record and sampling plan to determine the number of samples to be tested for odor.

4.1.2 Ensure all testing equipment (e.g., odor booths, sensory evaluation kits) is clean and ready for use.

4.1.3 Allow the cream samples to equilibrate to room temperature (e.g., 20°C to 25°C) if necessary.

4.1.4 Label all sample containers with necessary information, including sample ID, batch number, and date of preparation.

4.1.5 Wear appropriate personal protective equipment (PPE) such as gloves and lab coat.

4.2 Sample Presentation

4.2.1 Present the cream sample to the sensory evaluators in a clean, odor-free environment.

4.2.2 Ensure each evaluator receives the

sample in identical conditions to avoid bias.

4.2.3 Provide standardized instructions to the evaluators on the testing procedure and scoring system.

4.3 Odor Testing

4.3.1 Sensory Evaluation Method:

4.3.1.1 Ensure evaluators are familiar with the sensory attributes expected of the cream (e.g., absence of off-odors, characteristic fragrance).

4.3.1.2 Instruct evaluators to smell the cream sample and evaluate its odor intensity, quality, and any off-odors present.

4.3.1.3 Use a standardized scoring system (e.g., numerical scale or descriptive terms) to record the odor characteristics.

4.3.1.4 Collect evaluations from multiple evaluators to ensure reliability and consistency.

4.4 Quality Control

4.4.1 Perform odor testing on each cream sample batch to ensure consistent sensory quality.

4.4.2 Include control samples with known odor characteristics to validate evaluator responses.

4.4.3 Monitor and adjust testing conditions (e.g., room ventilation) to minimize environmental influences on odor perception.

4.5 Documentation and Review

4.5.1 Document all details of the odor testing procedure, including sample presentation, evaluator responses, and any deviations observed.

4.5.2 Review the odor test results and ensure they meet acceptance criteria specified in the product specifications or regulatory requirements.

4.5.3 Submit the odor test results for review and approval by QA personnel.

4.5.4 Maintain records of odor testing results according to company policy and regulatory requirements for future reference and audits.

5) Abbreviations, if any

QA: Quality Assurance

PPE: Personal Protective Equipment

SOP: Standard Operating Procedure

6) Documents, if any

Batch Records

Sampling Plan

Odor Testing Log

7) Reference, if any

ISO 5492: Sensory Analysis – Vocabulary

ASTM E679: Standard Practice for Determination of Odor and Taste Thresholds By a Forced-Choice Ascending Concentration Series Method of Limits

8) SOP Version

Version 1.0

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