Procedures for Taste and Odor Evaluation of Capsules

1) Purpose

The purpose of this SOP is to establish a standardized procedure for conducting sensory evaluations to confirm that capsules do not have objectionable taste or odor.

2) Scope

This SOP applies to all capsules produced within the pharmaceutical manufacturing facility intended for oral consumption.

3) Responsibilities

– QC personnel are responsible for conducting taste and odor evaluations.
– Sensory panel members must participate in the evaluations.
– QA personnel are responsible for reviewing and approving the evaluation results.

4) Procedure

1. Sensory Panel Preparation
1.1. Assemble a sensory evaluation panel consisting of trained personnel.
1.2. Ensure that panel members have no known allergies or sensitivities to the product.
1.3. Provide panel members with appropriate personal protective equipment (PPE) if required.
2. Sample Collection
2.1. Collect representative samples of capsules from each batch.
2.2. Ensure samples are collected at regular intervals during production.
2.3. Label each sample with batch number, date, and time of collection.
3. Taste and Odor Evaluation
3.1. Conduct the evaluation in a controlled environment free from strong odors and distractions.
3.2. Provide panel members with a standardized form for recording their observations.
3.3. Instruct panel members to:
3.3.1. Assess the odor of the capsule by gently sniffing it.
3.3.2. Assess the taste by placing the capsule in the mouth without swallowing, if safe to do so.
3.3.3. Record their observations regarding any off-tastes or odors.
4. Acceptance Criteria
4.1. Capsules should not have any objectionable taste or odor.
4.2. Any significant deviation from the expected taste or odor profile may indicate issues with the formulation or production process.
5. Documentation
5.1. Record all observations on the taste and odor evaluation form.
5.2. Include details such as batch number, date of evaluation, panel member names, and any observations.
5.3. Sign and date the evaluation form.
6. Review and Approval
6.1. Submit the completed evaluation forms to the QA department for review.
6.2. QA will review and approve the results based on the criteria outlined in this SOP.
7. Corrective Actions
7.1. If capsules fail the taste or odor evaluation, initiate a corrective action report.
7.2. Document all actions taken to address issues identified during the evaluations, including potential adjustments to the formulation or production process.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance
– PPE: Personal Protective Equipment

6) Documents, if any

– Taste and Odor Evaluation Form
– Corrective Action Report Form

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– USP <1168> Sensory Analysis

8) SOP Version

Version 1.0