components, and contact surfaces used in the sterile injectable production facility after cleaning and prior to use.

3. Responsibilities

• Filling Line Operator: Performs preliminary inspection and signs cleaning log.
• Production Supervisor: Performs secondary verification.
• Quality Assurance Officer: Conducts final inspection and documents release.

4. Accountability

The Head of Production and Head of QA are jointly accountable for ensuring that post-cleaning inspection is performed and documented for all sterile injectable filling lines.

5. Procedure

5.1 Pre-Inspection Requirements

1. Ensure cleaning has been completed as per approved cleaning SOP and logged appropriately.
2. All components must be dismantled and accessible for inspection where applicable.
3. Cleaning records (Annexure-1) must be available before initiating inspection.

5.2 Visual Inspection

1. Use white lint-free cloths, flashlight, and magnifiers where necessary.
2. Inspect all equipment surfaces including:
   • Filling needles
   • Tubing
   • Valves and joints
   • Hopper and holding tanks
   • Vial stoppers and tracks
3. Look for:
   • Residues or films
   • Particulate matter
   • Moisture or pooling
   • Corrosion or rust spots

5.3 Documentation

1. Complete Annexure-2: Post-Cleaning Inspection Checklist.
2. Include:
   • Inspector’s name and signature
   • Date and time of inspection
   • Observations made
   • Status: Passed/Needs Re-cleaning

5.4 QA Verification

1. QA officer to verify checklist entries and perform random checks.
2. Approve or reject filling line readiness using Annexure-3: Inspection Release Record.

5.5 Non-Compliance Handling

1. If any surface fails visual inspection:
   • Mark equipment “NOT READY FOR USE.”
   • Initiate re-cleaning and document in Annexure-4: Cleaning Failure Log.

5.6 Final Release

1. QA Officer signs Annexure-3 to approve the line for sterile operations.
2. Attach all inspection records to batch manufacturing documentation.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• cGMP: Current Good Manufacturing Practices

7. Documents

1. Annexure-1: Cleaning Activity Record
2. Annexure-2: Post-Cleaning Inspection Checklist
3. Annexure-3: Filling Line Inspection Release Record
4. Annexure-4: Cleaning Failure Log

8. References

• ICH Q7 Guidelines
• 21 CFR Part 211
• EU GMP Annex 1

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Cleaning Activity Record

Date	Equipment ID	Cleaned By	Checked By	Remarks
22/06/2025	FL-02	Ajay Mehra	Anita Reddy	NA

Annexure-2: Post-Cleaning Inspection Checklist

Area	Condition	Inspector	Date	Status
Needles	Clean	Sunita Reddy	22/06/2025	Pass

Annexure-3: Filling Line Inspection Release Record

Filling Line ID	Date	Approved By (QA)	Status
FL-02	22/06/2025	Vikram Rao	Approved

Annexure-4: Cleaning Failure Log

Date	Equipment ID	Issue Noted	Action Taken	Verified By
21/06/2025	FL-01	Visible Residue	Re-cleaned	QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
24/06/2025	2.0	Added visual inspection points and QA release documentation	Annual Review	QA Head