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
- Perform inspection under good illumination (minimum 1000 lux) and neutral background (preferably white or grey).
- Wear gloves, mask, and protective garments to avoid contamination.
- 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
- 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
- Color, consistency, and odor should match with standard batch or MFR description.
- No visible foreign particles should be present. If found, segregate sample and escalate for investigation.
- If inconsistencies are observed in uniformity, perform mixing or homogenization and reinspect.
5.4 Documentation
- Record findings in the Visual Inspection Logbook (Annexure-1) with date, batch number, stage, and initials.
- Affix photograph (if required by protocol or investigation).
- 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
- Visual Inspection Logbook (Annexure-1)
- Batch Manufacturing Record
- 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 |