SOP is applicable to all activities involved in the preparation, filtration, aseptic filling, sealing, and packaging of SC injection products manufactured within the sterile injectable department.

3. Responsibilities

• Manufacturing Officer: Executes formulation, filling, and documentation as per BMR.
• Quality Assurance Officer: Monitors compliance and reviews records.
• Microbiologist: Conducts environmental and sterility monitoring.
• Maintenance Engineer: Ensures equipment functionality and preventive maintenance.

4. Accountability

The Head of Manufacturing is accountable for implementation, compliance, and final batch release readiness.

5. Procedure

5.1 Pre-Manufacturing Checks

1. Ensure the manufacturing area is cleaned and sanitized. Record in area cleaning log.
2. Verify calibration status and cleanliness of equipment to be used.
3. Ensure availability of approved BMR and verify raw material quantities.

5.2 Formulation Preparation

1. Transfer pre-weighed materials from dispensing to manufacturing via pass box.
2. Dissolve APIs and excipients in Water for Injection (WFI) in SS316L compounding vessel.
3. Maintain temperature (if required) and stir with validated agitator until homogenous.
4. Record batch number, temperature, pH, and mixing time in Annexure-1.

5.3 Filtration and Sterile Transfer

1. Filter solution through 0.45 µm and then 0.22 µm sterile-grade membrane filters.
2. Use sterile tubing and transfer the solution aseptically to the filling vessel under LAF.
3. Perform pre- and post-filtration integrity tests. Record in Annexure-2.

5.4 Aseptic Filling and Sealing

1. Load cleaned and sterilized vials or prefilled syringes into filling line.
2. Fill the formulation as per volume specifications under Grade A environment.
3. Seal using pre-validated capping or plunger-sealing equipment.
4. Inspect filled containers visually for particles, leaks, and proper volume (Annexure-3).

5.5 In-Process Controls

1. Verify volume fill accuracy, appearance, and clarity of solution every 30 minutes.
2. Check environmental conditions – temperature, humidity, differential pressure.
3. Record all results in Annexure-4: IPC Log.

5.6 Batch Completion

1. Transfer filled units to quarantine area labeled as “Under QC.”
2. Clean the equipment and area according to respective cleaning SOPs.
3. Ensure BMR entries are completed and signed by QA and production.

6. Abbreviations

• SC: Subcutaneous
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• WFI: Water for Injection
• LAF: Laminar Air Flow

7. Documents

1. Batch Manufacturing Log – Annexure-1
2. Filter Integrity Report – Annexure-2
3. Visual Inspection Report – Annexure-3
4. In-Process Control Log – Annexure-4

8. References

• ICH Q8 – Pharmaceutical Development
• WHO GMP for Sterile Pharmaceutical Products
• Schedule M – Indian Drugs & Cosmetics Act

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Deepa Nair	Ravi Deshmukh	Dr. Vandana Shah
Designation	Production Officer	QA Executive	QA Head
Department	Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Batch Manufacturing Log

Date	Batch No.	pH	Temp (°C)	Mix Time	Operator
17/06/2025	SC/0625/07	6.2	25	45 min	Suraj Patil

Annexure-2: Filter Integrity Report

Filter ID	Type	Pre-Test	Post-Test	Status
FILT-SC-02	0.22 µm	Pass	Pass	Pass

Annexure-3: Visual Inspection Report

Unit No.	Clarity	Foreign Particles	Seal	Result
SC00741	Clear	Absent	Intact	Pass

Annexure-4: In-Process Control Log

Time	Fill Volume	Clarity	Temp (°C)	Remarks
10:30	0.9 mL	Clear	24.5	OK

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	Updated for latest validation procedures and annexures	Annual Review	QA Head