Acceptability Criteria for Taste and Odor of Capsules
1) Purpose
The purpose of this SOP is to define the criteria for acceptable taste and odor characteristics of capsules intended for oral consumption to ensure consumer acceptability and product quality.
2) Scope
This SOP applies to all capsules manufactured in the pharmaceutical facility that require taste and odor evaluation as part of their quality control process.
3) Responsibilities
– QC personnel are responsible for evaluating and documenting the taste and odor of capsules.
– Sensory panel members are responsible for assessing the taste and odor based on the established criteria.
– QA personnel are responsible for reviewing and approving the sensory evaluation results.
4) Procedure
1. Criteria for Taste Acceptability
1.1. Taste Intensity
1.1.1. Capsules should have a mild taste that is not overpowering or unpleasant.
1.1.2. Strong or extreme tastes (e.g., very bitter or sour) are generally unacceptable.
1.2. Taste Quality
1.2.1. The taste should be consistent with the intended flavor profile (if applicable).
1.2.2. Off-flavors
2. Criteria for Odor Acceptability
2.1. Odor Intensity
2.1.1. Capsules should have a neutral to mild odor.
2.1.2. Strong or pungent odors are generally unacceptable.
2.2. Odor Quality
2.2.1. The odor should be consistent with the intended scent (if applicable).
2.2.2. Unusual or off-putting odors are grounds for rejection.
3. Sensory Evaluation
3.1. Conduct the sensory evaluation as per the SOP for evaluating taste and odor of capsules.
3.2. Use a standardized scale (e.g., 1 to 5) for both taste and odor to determine acceptability.
3.2.1. A score of 3 or above indicates acceptable taste and odor.
3.2.2. A score below 3 requires further investigation and potential rejection.
4. Documentation
4.1. Record all sensory evaluation results on the evaluation form.
4.2. Include batch number, date, and names of sensory panel members.
5. Review and Approval
5.1. Submit the completed evaluation forms to the QA department for review.
5.2. QA will review and approve the results based on the criteria outlined in this SOP.
6. Corrective Actions
6.1. If capsules fail to meet taste or odor criteria, initiate a corrective action report.
6.2. Document and address all corrective actions taken and re-evaluate the batch 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
