quality checks.

3. Responsibilities

• Production Chemist: Perform initial observation and record any deviations in the Batch Manufacturing Record (BMR).
• QC Analyst: Confirm and document the observations in laboratory logs and compare with reference standards.
• QA Officer: Review recorded observations and manage deviations or investigations if required.

4. Accountability

Production Head is accountable for proper in-process monitoring. QC Head is responsible for ensuring accuracy and compliance in documentation.

5. Procedure

5.1 Sample Collection

1. Collect ~5–10 g of the intermediate in a clean, dry glass container immediately after the relevant process step (e.g., filtration, drying, or crystallization).
2. Ensure the sample is representative by sampling from multiple locations if applicable.
3. Label the container with Product Name, Batch No., Sampling Stage, Date, and Time.

5.2 Color Assessment

1. Place the sample against a white background under daylight equivalent light (D65 or 6000–6500 K).
2. Compare color visually with standard/reference material or documented appearance in BMR.
3. Describe color using standard terminology (e.g., off-white, pale yellow, brownish grey).
4. If deviation is observed, document using “Color and Odor Deviation Form” (Annexure-1) and notify QA.

5.3 Odor Assessment

1. Carefully waft vapor from the sample towards the nose without direct inhalation.
2. Use a clean fume hood if required for hazardous materials.
3. Compare odor with process expectations (e.g., sulfur-like, solvent odor, acidic, aromatic, odorless).
4. Note intensity (e.g., mild, strong, pungent) and any unusual smells that may indicate impurity or degradation.

5.4 Acceptance Criteria

1. Color and odor must match the specification or range mentioned in the Master Formula Record (MFR) or analytical method.
2. Deviations must be evaluated through additional analytical testing (e.g., HPLC, GC) if needed.
3. QA shall assess impact on product quality and decide on batch disposition.

5.5 Documentation and Records

1. Enter observations in the Batch Manufacturing Record and QC worksheet.
2. Attach reference color photograph or comparator (if available) for traceability.
3. Maintain all forms and logs as per documentation SOP.

6. Abbreviations

• SOP: Standard Operating Procedure
• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• MFR: Master Formula Record
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Color and Odor Deviation Form (Annexure-1)
2. Batch Manufacturing Record
3. Reference Color Comparator (if applicable)

8. References

• ICH Q8 – Pharmaceutical Development
• 21 CFR Part 211 – US FDA cGMP
• Internal Visual Inspection and Sensory Evaluation SOP

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Color and Odor Deviation Form

Date	Batch No.	Sampling Stage	Observed Color	Observed Odor	Expected Appearance	Remarks
13/04/2025	API-20250413	Post-Crystallization	Off-white	Mild solvent odor	White, odorless	Referred to QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Visual Check Requirement	QA Head
13/04/2025	2.0	Added Odor Intensity and Comparator Reference Section	Process Standardization	QA Head