Standard Operating Procedure for Preparation of Solutions

1) Purpose

The purpose of this SOP is to outline the procedures for the preparation of solutions to ensure their quality and consistency for use in the manufacturing of injection products.

2) Scope

This SOP applies to all personnel involved in the preparation of solutions at [Company Name] used for the manufacturing of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Preparing solutions according to approved formulas and procedures.
– Quality Control (QC) Department: Testing and verifying the quality of prepared solutions.
– Quality Assurance (QA) Department: Reviewing and approving solution preparation procedures and records.

4) Procedure

4.1 Preparation for Solution Making
4.1.1 Ensure all raw materials are approved and have passed quality control tests.
4.1.2 Verify the cleanliness and integrity of all equipment and containers to be used in the preparation.
4.2 Weighing and Measuring
4.2.1 Weigh and measure raw materials accurately using calibrated scales and measuring devices.
4.2.2 Record all weights and measures in the batch record.
4.3 Mixing Process
4.3.1 Add raw materials to the mixing vessel in the specified order according to the formula.
4.3.2 Mix the solution using the appropriate mixing speed and duration as specified in the procedure.
4.3.3 Monitor and record the mixing parameters (e.g., temperature, pH) during the process.
4.4 Quality Control Testing
4.4.1 Take samples of the solution for quality control testing.
4.4.2 Perform tests to verify that the solution meets specified quality criteria (e.g., concentration, pH, sterility).
4.4.3 Record test results and compare them with established acceptance criteria.
4.4.4 If the solution fails to meet quality criteria, investigate the cause and take corrective actions.
4.5 Filtration and Transfer
4.5.1 Filter the solution through an appropriate filter to remove particulates and ensure sterility.
4.5.2 Transfer the filtered solution to a clean, labeled storage container.
4.6 Documentation
4.6.1 Maintain records of all preparation steps, including raw material batch numbers, weights, measures, mixing parameters, and test results.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Batch Records
– Quality Control Test Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0