Standard Operating Procedure for Chemical Preparation Area Operations in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/125/2025
Supersedes	SOP/BS/125/2022
Page No.	Page 1 of 12
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for safe, accurate, and GMP-compliant preparation and handling of chemicals used in upstream biosimilar operations within the designated chemical preparation area.

2. Scope

This SOP applies to the receipt, weighing, solution preparation, labeling, and storage of raw chemicals including buffers, acids, alkalis, and media supplements in the biosimilar manufacturing facility.

3. Responsibilities

• Production Staff: Prepare and label chemical solutions as per batch requirements.
• Warehouse Staff: Transfer materials to chemical preparation area after approval.
• QA: Ensure proper documentation, labeling, and area cleanliness.

4. Accountability

The Production Manager is accountable for adherence to chemical preparation protocols and for maintaining a contamination-free preparation area.

5. Procedure

5.1 Area Readiness

1. Verify area cleaning as per SOP/BS/067/2025 and record in cleaning log.
2. Ensure availability of:
   • Weighing balances (calibrated)
   • Stirring devices
   • Personal Protective Equipment (PPE)
   • SDS (Safety Data Sheets) for each chemical

5.2 Material Transfer and Verification

1. Receive materials from warehouse with Approved Label.
2. Verify:
   • Name and Grade
   • Batch No. and Expiry
   • CoA match
3. Log material details in Annexure-1: Material Receipt Log.

5.3 Chemical Solution Preparation

1. Weigh quantity using balance within ±0.1% accuracy.
2. Use appropriate container based on volume and reactivity.
3. Dissolve using RO/DI water and mix until completely clear (unless otherwise instructed).
4. Adjust pH if required using 1N HCl/NaOH with calibrated pH meter.
5. Label the solution with:
   • Name of Solution
   • Prepared by
   • Preparation Date
   • Expiry Date
   • Batch/Lot No.
6. Record all details in Annexure-2: Solution Preparation Log.

5.4 Storage and Use

1. Store solutions in labeled carboys or sterile bottles based on usage.
2. Store under specified conditions (e.g., 2–8°C, ambient) as per chemical nature.
3. Discard expired or unused solutions after review by QA.

5.5 Cleaning and Decontamination

1. After each batch preparation:
   • Clean all equipment using detergent and rinse with purified water.
   • Dry and store utensils in designated area.
2. Record cleaning in Annexure-3.

6. Abbreviations

• SDS: Safety Data Sheet
• DI: Deionized
• CoA: Certificate of Analysis
• QA: Quality Assurance

7. Documents

1. Material Receipt Log – Annexure-1
2. Solution Preparation Log – Annexure-2
3. Cleaning Log for Chemical Prep Area – Annexure-3

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO TRS 1019 – Annex 2
• Internal SOP on Equipment Calibration and Cleaning

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Receipt Log

Date	Material Name	Batch No.	Expiry	Checked By
04/05/2025	Sodium Phosphate	SP2025B	03/2027	Sunita Reddy

Annexure-2: Solution Preparation Log

Date	Solution	Volume	pH	Prepared By	Expiry
04/05/2025	Phosphate Buffer	10L	7.2	Ajay Verma	06/05/2025

Annexure-3: Cleaning Log for Chemical Prep Area

Date	Area/Item Cleaned	Method Used	Cleaned By	Verified By
04/05/2025	Stirrer	Detergent + DI Water	Sunita Reddy	QA Staff

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Included pH adjustment and clarified labeling instructions	GMP gap assessment