GMP-compliant, aseptic conditions to achieve product safety, quality, and consistency.

2. Scope

This SOP applies to the formulation, compounding, filtration, filling, and sealing of intravenous injection products within the sterile injectable manufacturing facility.

3. Responsibilities

• Production Supervisor: Ensures manufacturing as per BMR and supervises entire process.
• Production Operator: Executes each step including solution preparation, filtration, and filling.
• Quality Assurance (QA): Performs in-process checks, batch record review, and line clearance.
• Engineering: Ensures equipment readiness and preventive maintenance.
• Microbiology: Monitors environmental and aseptic conditions.

4. Accountability

The Manufacturing Head is accountable for overall compliance with this SOP and final release readiness of the IV injection batch.

5. Procedure

5.1 Pre-Manufacturing Activities

1. Verify issuance of approved Batch Manufacturing Record (BMR).
2. Confirm availability of all required raw materials and packaging components.
3. Ensure area clearance is done and Line Clearance is signed by QA.

5.2 Solution Preparation

1. Transfer weighed materials to the compounding area through pass box.
2. Prepare bulk solution in SS316 compounding vessel with WFI under LAF.
3. Use magnetic stirrer or mechanical stirrer as per BMR instruction.
4. Maintain pH and osmolality parameters within defined limits.
5. Record all parameters in Solution Preparation Log (Annexure-1).

5.3 Filtration

1. Use pre-validated 0.22 µm sterilizing grade membrane filters.
2. Filter the bulk solution using a filter assembly under aseptic conditions.
3. Perform integrity test (bubble point/diffusion) post-filtration and document in Annexure-2.

5.4 Filling and Sealing

1. Transfer filtered solution to the filling line under laminar airflow.
2. Start vial/bottle/syringe filling under Grade A conditions.
3. Seal immediately post-filling using pre-set equipment (capper/sealer).
4. Perform weight variation check every 30 minutes and document in Annexure-3.

5.5 In-Process Checks

1. Perform particulate matter check, pH, and appearance test during batch filling.
2. Verify environmental monitoring at regular intervals (settle plates, air sampling).
3. Document all checks in IPC Log Sheet (Annexure-4).

5.6 Post-Manufacturing

1. Label all units with batch number, expiry, and storage condition.
2. Store sealed units in a designated quarantine area until QC release.
3. Ensure all used equipment is cleaned as per SOP/SIM/051/2025.

5.7 Documentation

1. Ensure BMR entries are made in real-time and cross-verified by QA.
2. All annexures must be filled with batch-specific data and archived post-approval.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• WFI: Water for Injection
• IPC: In-Process Control

7. Documents

1. Solution Preparation Log – Annexure-1
2. Filter Integrity Test Record – Annexure-2
3. Weight Variation Log – Annexure-3
4. IPC Record Sheet – Annexure-4

8. References

• WHO TRS 986 – Annex 2
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Sunita Reddy	Rajesh Kumar	Anil Sharma
Designation	Production Officer	QA Officer	QA Head
Department	Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Solution Preparation Log

Date	Batch No.	Volume Prepared	pH	Operator
15/06/2025	IV/0625/01	100 L	6.8	Ravi Deshmukh

Annexure-2: Filter Integrity Test Record

Filter ID	Type	Bubble Point	Result	Analyst
FILT/001	0.22 µm	54 psi	Pass	Priya Nair

Annexure-3: Weight Variation Log

Time	Sample No.	Target Volume	Actual Volume	Status
10:30	5	10 mL	10.1 mL	Acceptable

Annexure-4: IPC Record Sheet

Test	Result	Spec.	Status	Analyst
pH	6.8	6.5-7.5	Pass	Rekha Mehta

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/02/2022	1.0	Initial release	New SOP	QA Head
18/06/2025	2.0	Updated with filtration integrity and annexures	Annual Review	QA Head