applies to all batch manufacturing activities related to IM injections within the sterile injectable manufacturing department, including both aqueous and oily formulations.

3. Responsibilities

• Production Chemist: Executes the formulation and filling as per BMR.
• QA Executive: Ensures in-process verification and GMP compliance.
• Microbiology Personnel: Conducts environmental monitoring.
• Engineering Staff: Maintains equipment calibration and readiness.

4. Accountability

The Production Manager is accountable for implementation of the procedure and ensuring batch quality and regulatory compliance.

5. Procedure

5.1 Pre-Batch Preparation

1. Obtain the approved BMR and verify all raw materials and packaging components.
2. Ensure line clearance and area cleaning is completed and documented.
3. Confirm calibration status of all measuring and processing equipment.

5.2 Solution Formulation

1. Transfer raw materials to the compounding area under controlled conditions.
2. Prepare the IM formulation (aqueous/oily) in a jacketed SS316 compounding vessel.
3. Maintain temperature as required (e.g., 60–70°C for oily vehicles).
4. Stir the solution continuously using a validated agitator until homogeneity is achieved.
5. Record temperature, mixing speed, and time in Annexure-1.

5.3 Filtration and Sterilization

1. Filter the compounded solution through 0.45 µm followed by 0.22 µm membrane filters.
2. For thermolabile IM formulations, use aseptic filtration under Grade A LAF.
3. For thermostable formulations, perform terminal sterilization in an autoclave.
4. Conduct filter integrity tests post-filtration and record in Annexure-2.

5.4 Filling and Sealing

1. Set up the vial/syringe filling line under aseptic conditions in Grade A/B area.
2. Perform media fill simulation validation before product filling.
3. Fill product into containers as per volume specifications (e.g., 1 mL, 2 mL).
4. Seal vials using aluminum crimping or syringe plungers and caps.
5. Perform visual inspection and leak testing of filled units (Annexure-3).

5.5 In-Process Controls

1. Check filled volume accuracy, clarity, pH, and fill weight.
2. Monitor temperature, humidity, differential pressure during the operation.
3. Document results in In-Process Check Sheet (Annexure-4).

5.6 Post-Manufacturing

1. Label filled units with appropriate batch details and transfer to quarantine area.
2. Clean equipment and fill line as per respective cleaning SOPs.
3. Ensure all BMR entries are completed and verified by QA.

6. Abbreviations

• IM: Intramuscular
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• LAF: Laminar Air Flow
• GMP: Good Manufacturing Practice

7. Documents

1. Formulation Log – Annexure-1
2. Filter Integrity Test Record – Annexure-2
3. Visual Inspection Report – Annexure-3
4. In-Process Control Checklist – Annexure-4

8. References

• WHO Guidelines for Sterile Pharmaceutical Products
• Schedule M – Drugs and Cosmetics Act (India)
• EU GMP Annex 1

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Neha Gupta	Sachin Patil	Dr. Asha Menon
Designation	Production Executive	QA Executive	QA Head
Department	Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Formulation Log

Date	Batch No.	Volume	Temp (°C)	Stirring Time	Operator
16/06/2025	IM/0625/04	150 L	65	60 min	Ajay Sharma

Annexure-2: Filter Integrity Test Record

Filter ID	Type	Test Performed	Result	Analyst
FT-IM-01	0.22 µm	Bubble Point	Pass	Pooja Rao

Annexure-3: Visual Inspection Report

Container No.	Clarity	Foreign Matter	Result	Inspector
IM0625041	Clear	Absent	Pass	Mahesh Kulkarni

Annexure-4: In-Process Control Checklist

Parameter	Result	Spec.	Status	Checked By
pH	5.5	5.0–6.0	Pass	Kavita Joshi

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 to include filter integrity & IPC	Annual Review	QA Head