formulation, sterile filtration, aseptic filling, sealing, and inspection of intradermal injection products manufactured in the Sterile Injectable Manufacturing area.

3. Responsibilities

• Production Officer: Executes all steps of manufacturing as per Batch Manufacturing Record (BMR).
• QA Officer: Monitors in-process activities and verifies compliance with SOPs and specifications.
• Engineering Team: Ensures readiness, calibration, and maintenance of processing and filling equipment.
• QC Officer: Conducts sampling and testing of in-process and finished products.

4. Accountability

The Head of Production is accountable for proper execution and compliance with this SOP. The Head of QA is accountable for final batch release decision.

5. Procedure

5.1 Pre-Manufacturing Activities

1. Verify availability and status of raw materials, primary packaging, and documentation.
2. Ensure manufacturing area cleaning and sanitization as per SOP.
3. Verify line clearance with QA and fill Annexure-1.

5.2 Solution Preparation

1. Transfer required raw materials using dynamic pass box following gowning protocol.
2. Dissolve the API and excipients in WFI in a jacketed SS316L tank under continuous stirring.
3. Maintain solution temperature within the defined range and monitor pH.
4. Filter solution through 5 µm pre-filter prior to sterile filtration.

5.3 Sterile Filtration

1. Transfer solution to a sterile filtration vessel using closed-loop transfer tubing.
2. Perform sterile filtration using 0.22 µm membrane filter.
3. Conduct integrity test (Bubble Point/Diffusion Flow) before and after filtration. Record in Annexure-2.

5.4 Aseptic Filling and Sealing

1. Carry out filling in Grade A LAF area by trained personnel.
2. Ensure filling accuracy and sealing integrity of vials or ampoules.
3. Stoppering and sealing to be performed using pre-sterilized components.
4. Perform 100% visual inspection post-filling (Annexure-3).

5.5 In-Process Controls

1. Check pH, volume, particulate matter, appearance, and container integrity at defined intervals.
2. Document all in-process parameters in Annexure-4.
3. Report deviations immediately to QA and document corrective actions.

5.6 Post-Manufacturing Procedures

1. Label all filled containers with “QUARANTINE” tag and store in designated area.
2. Clean all equipment and accessories used during the process as per SOP.
3. Compile and submit completed BMR to QA for review.

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• BMR: Batch Manufacturing Record
• LAF: Laminar Air Flow
• QA: Quality Assurance

7. Documents

1. Line Clearance Checklist – Annexure-1
2. Filter Integrity Test Log – Annexure-2
3. Visual Inspection Report – Annexure-3
4. In-Process Quality Log – Annexure-4

8. References

• ICH Q7: GMP for Active Pharmaceutical Ingredients
• WHO Technical Report Series 986 Annex 2
• Schedule M – Good Manufacturing Practices and Requirements of Premises, Plant and Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Kiran Jagtap	Smita Desai	Dr. Arvind Sethi
Designation	Production Officer	QA Officer	Head QA
Department	Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Line Clearance Checklist

Area	Cleared By	Date	Remarks
Filling Room	Sunita Reddy	17/06/2025	No material left

Annexure-2: Filter Integrity Test Log

Filter ID	Type	Pre-Test	Post-Test	Result
FILT-072	0.22 µm	Pass	Pass	Compliant

Annexure-3: Visual Inspection Report

Container No.	Appearance	Particles	Seal	Status
IN-0034	Clear	None	Intact	Accepted

Annexure-4: In-Process Quality Log

Time	Volume	Appearance	pH	Checked By
10:00 AM	0.1 mL	Clear	6.8	Ravi Mehta

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Annexures and in-process logs updated	Planned Revision	QA Head