Taste and Odor Assessment of Capsules
1) Purpose
The purpose of this SOP is to provide a standardized method for evaluating the taste and odor of capsules, especially those intended for oral consumption, to ensure they meet acceptable sensory quality standards.
2) Scope
This SOP applies to all capsules produced in the pharmaceutical manufacturing facility that are intended for oral consumption and require taste and odor evaluation as part of quality control.
3) Responsibilities
– QC personnel are responsible for conducting taste and odor evaluations.
– Sensory panel members are responsible for providing consistent and unbiased feedback on taste and odor.
– QA personnel are responsible for reviewing and approving sensory evaluation results.
4) Procedure
1. Preparation for Evaluation
1.1. Ensure the evaluation area is clean and free from strong odors.
1.2. Prepare a controlled environment with minimal distractions.
1.3. Gather all necessary materials, including sample capsules, evaluation forms, and water for rinsing.
1.4. Ensure sensory panel members are briefed on the evaluation criteria and procedures.
2. Sample Preparation
2.1. Select a random sample of capsules from the batch.
2.2. Ensure capsules are at room temperature and free from any packaging material.
2.3. Provide each panel member with an identical sample for evaluation.
3. Evaluation Process
3.1. Taste Evaluation
3.1.1. Each panel member will place a capsule on their tongue and assess the taste for 30 seconds.
3.1.2. Record the intensity and type of taste (e.g., sweet, bitter, sour, salty).
3.1.3. Use a standardized scale (e.g., 1 to 5) to rate the acceptability of the taste.
3.2. Odor Evaluation
3.2.1. Each panel member will smell the capsule before tasting.
3.2.2. Record the intensity and type of odor (e.g., medicinal, chemical, fruity).
3.2.3. Use a standardized scale (e.g., 1 to 5) to rate the acceptability of the odor.
4. Documentation
4.1. Record all observations and ratings on the evaluation form.
4.2. Include the batch number, date of evaluation, and names of panel members.
5. Review and Approval
5.1. Submit completed evaluation forms to the QA department for review.
5.2. QA will review the results and determine if the batch meets sensory quality standards.
6. Corrective Actions
6.1. If the batch fails the taste or odor evaluation, initiate a corrective action report.
6.2. Document all corrective actions taken and re-evaluate if necessary.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Sensory Evaluation Form
– Corrective Action Report Form
7) Reference, if any
– ICH Q8(R2) – Pharmaceutical Development
– FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
8) SOP Version
Version 1.0
