with cGMP and applicable regulatory requirements.

2. Scope

This SOP applies to the inspection of bulk injectable solutions prepared in the manufacturing area before they are transferred to the aseptic filling line.

3. Responsibilities

• Production Operator: Performs physical inspection and reports observations.
• Production Supervisor: Ensures inspection is completed before filling begins.
• Quality Assurance (QA): Performs independent verification and releases solution for filling.
• QC Chemist: Ensures in-process testing and analytical parameters are met before inspection.

4. Accountability

The Head – Production is accountable for ensuring implementation of this SOP and that no uninspected solution is filled.

5. Procedure

5.1 Preparation for Inspection

1. Verify that the bulk solution is stored in a sterilized and labeled manufacturing vessel.
2. Ensure batch manufacturing record (BMR) entries are completed for solution preparation.
3. Check the temperature, pH, and volume of the solution before initiating inspection.
4. Confirm the completion and approval of in-process quality control testing (Annexure-1).

5.2 Visual Inspection for Clarity and Particulate Matter

1. Under adequate lighting conditions in a controlled area, withdraw 10–20 mL of solution using a sterile syringe or pipette.
2. Transfer the sample to a clear glass vial and examine against white and black background for clarity.
3. Check for any visible particulates, fibers, precipitates, or foreign matter.
4. If particles are observed, notify QA and repeat filtration through 0.22 µm filters.

5.3 pH, Color, and Odor Verification

1. Use a calibrated pH meter to measure solution pH and document it.
2. Visually compare color of the solution to product specification range.
3. Ensure solution has no objectionable odor or discoloration.

5.4 Filtration Integrity

1. Review the sterile filtration log (Annexure-2) to ensure that solution was filtered using validated filter system.
2. Ensure filter integrity test (bubble point/diffusion) results are within specification.
3. Confirm that no filter integrity failure occurred during processing.

5.5 QA Clearance

1. QA personnel independently verify clarity, particulate absence, and filtration records.
2. Sign off the Inspection Clearance Form (Annexure-3) before batch is transferred to the filling area.

5.6 Documentation

1. Record all inspection results and observations in BMR and annexure forms.
2. Ensure records are reviewed and signed by authorized personnel.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• µm: Micrometer

7. Documents

1. In-Process QC Test Record – Annexure-1
2. Sterile Filtration Log – Annexure-2
3. Inspection Clearance Form – Annexure-3

8. References

• WHO Technical Report Series 961: Annex 6
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU GMP Guidelines – Annex 1

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: In-Process QC Test Record

Date	Batch No.	Test Performed	Result	Approved By
18/06/2025	INJ-2234	pH	6.5	Dr. Pooja Iyer
18/06/2025	INJ-2234	Osmolarity	295 mOsm	Dr. Pooja Iyer

Annexure-2: Sterile Filtration Log

Filter ID	Batch No.	Pore Size	Integrity Test	Status	Performed By
FILT-178	INJ-2234	0.22 µm	Bubble Point	Pass	Ravi Thakur

Annexure-3: Inspection Clearance Form

Batch No.	Clarity	Particulate Status	QA Verified	Comments
INJ-2234	Clear	No Particles	Yes	Approved for Filling

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/04/2022	1.0	Initial issue	New SOP	QA Head
18/06/2025	2.0	Incorporated filtration integrity and QA verification	Periodic Review	QA Head