Standard Operating Procedure for Visual Inspection of Semi-Solid Intermediates in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/096/2025
Supersedes	SOP/API/096/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the standard procedure for performing visual inspection of semi-solid intermediates during API manufacturing for monitoring appearance, color, uniformity, and identification of foreign particles or physical non-conformities.

2. Scope

This SOP applies to semi-solid intermediates such as wet cake, slurry, or partially dried mass generated during the synthesis and isolation stages of API production.

3. Responsibilities

• Production Chemist: Perform routine visual inspections during each processing stage and record observations.
• QC Analyst: Assist in confirming and documenting any abnormalities detected during inspection.
• QA Officer: Review records and approve or reject batches based on inspection findings and risk assessment.

4. Accountability

Production Head is accountable for conducting inspections. QA Head is accountable for reviewing outcomes and ensuring GMP compliance.

5. Procedure

5.1 Inspection Conditions

1. Perform inspection under good illumination (minimum 1000 lux) and neutral background (preferably white or grey).
2. Wear gloves, mask, and protective garments to avoid contamination.
3. Use a clean stainless-steel spatula to collect a small quantity of the intermediate into a glass or SS dish for evaluation.

5.2 Visual Parameters

1. Observe and record the following parameters:
   • Color: Compare with expected color range mentioned in the BMR or MFR.
   • Consistency: Evaluate whether the intermediate is homogenous, lumpy, granular, pasty, or oily.
   • Phase Separation: Check for any liquid phase settling in slurry or semi-solid form.
   • Foreign Matter: Inspect for presence of fibers, dust, glass, rubber particles, metal fragments, or black spots.
   • Odor (if applicable): Smell should be characteristic and within acceptable threshold.

5.3 Acceptance Criteria

1. Color, consistency, and odor should match with standard batch or MFR description.
2. No visible foreign particles should be present. If found, segregate sample and escalate for investigation.
3. If inconsistencies are observed in uniformity, perform mixing or homogenization and reinspect.

5.4 Documentation

1. Record findings in the Visual Inspection Logbook (Annexure-1) with date, batch number, stage, and initials.
2. Affix photograph (if required by protocol or investigation).
3. For deviations, initiate deviation form and seek QA decision before further processing.

6. Abbreviations

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

7. Documents

1. Visual Inspection Logbook (Annexure-1)
2. Batch Manufacturing Record
3. Deviation Form (if required)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA GMP
• WHO TRS 986 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Visual Inspection Logbook

Date	Batch No.	Stage	Observed Color	Consistency	Foreign Matter	Performed By	Remarks
13/04/2025	API-20250413	Post-Filtration	Pale Yellow	Homogeneous Slurry	None		Complies

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	Process Visual Control	QA Head
13/04/2025	2.0	Added Criteria for Odor and Photo Documentation	Audit Compliance	QA Head