Taste and Odor Evaluation Record-Keeping
1) Purpose
The purpose of this SOP is to establish a standardized procedure for maintaining accurate and thorough records of taste and odor evaluations for capsules to ensure traceability and compliance with regulatory requirements.
2) Scope
This SOP applies to all taste and odor evaluations conducted on capsules within the pharmaceutical manufacturing facility.
3) Responsibilities
– QC personnel are responsible for recording the results of taste and odor evaluations.
– Sensory panel members are responsible for providing accurate and unbiased feedback.
– QA personnel are responsible for reviewing and maintaining the records of taste and odor evaluations.
4) Procedure
1. Preparation for Record-Keeping
1.1. Ensure the availability of standardized evaluation forms and documentation tools.
1.2. Verify that all forms are the current and controlled versions.
2. Documentation of Evaluations
2.1. Immediately document the results of taste and odor evaluations upon completion.
2.2. Include the following details in the evaluation form:
2.2.1. Batch number
2.2.2. Date and time of evaluation
2.2.3. Names of sensory
2.2.4. Number of capsules evaluated
2.2.5. Detailed observations on taste and odor characteristics
2.2.6. Scores and ratings as per the standardized scale
2.2.7. Acceptance or rejection decision
2.3. Use clear, legible handwriting or electronic entry as specified.
3. Review and Approval
3.1. Submit the completed evaluation forms to the production supervisor for initial review.
3.2. The QA department will perform a final review and approval of the documentation.
3.3. Address any discrepancies or issues noted during the review promptly.
4. Filing and Storage
4.1. File the approved evaluation forms in the batch record.
4.2. Store batch records as per the company’s document retention policy.
5. Corrective Actions
5.1. If the batch is rejected based on taste or odor evaluations, initiate a corrective action report.
5.2. Document all corrective actions taken and re-evaluate if necessary.
5) Abbreviations, if any
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Taste and Odor Evaluation Form
– Batch Record
– Corrective Action Report Form
7) Reference, if any
– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– EMA Guidelines on Good Manufacturing Practice
8) SOP Version
Version 1.0