Standard Operating Procedure for Reconstitution Testing
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for conducting reconstitution testing of pharmaceutical products, including Intramuscular (IM) and Subcutaneous (SC) injections, to ensure that the product can be properly reconstituted prior to administration.
2) Scope
This SOP applies to all personnel involved in the reconstitution testing of pharmaceutical products within the pharmaceutical manufacturing facility. It covers the procedures for sample preparation, reconstitution, and testing.
3) Responsibilities
– Quality Control (QC) Department: Responsible for performing reconstitution tests and recording data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Production Department: Provides samples for reconstitution testing as per the testing protocol.
4) Procedure
4.1 Sample Preparation
4.1.1 Obtain representative samples of the product in its final packaging.
4.1.2 Ensure samples are properly labeled with batch number and expiration date.
4.2 Reconstitution Process
4.2.1 Review the product’s reconstitution instructions as provided in the product labeling or insert.
4.2.2 Prepare the reconstitution medium (e.g., sterile water for injection) as specified.
4.2.3 Reconstitute the sample by adding the specified volume of the reconstitution medium to the product vial or container.
4.2.4 Mix gently by swirling or inverting the vial/container until the product is fully dissolved or dispersed.
4.3 Testing
4.3.1 Inspect the reconstituted solution for clarity, color, and absence of particulates.
4.3.2 Measure the pH and osmolality of the reconstituted solution, if applicable.
4.3.3 Perform any additional tests specified in the product’s monograph, such as potency, sterility, or particulate matter testing.
4.4 Data Analysis
4.4.1 Record all observations and measurements in the reconstitution testing logbook or electronic database.
4.4.2 Compare the results against predefined specifications to ensure the product meets the required quality standards.
4.5 Documentation
4.5.1 Document all test results, including raw data and observations.
4.5.2 Ensure that all records are reviewed and approved by the QC department.
4.6 Reporting
4.6.1 Prepare a reconstitution testing report summarizing the methodology, results, and any deviations observed.
4.6.2 Submit the report to the QA department for review and approval.
4.7 Corrective Actions
4.7.1 If any test results do not meet specifications, initiate an investigation to identify the root cause.
4.7.2 Implement corrective actions as necessary and document all findings and actions taken.
5) Abbreviations, if any
– IM: Intramuscular
– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance
6) Documents, if any
– Reconstitution Testing Logbook
– Reconstitution Testing Reports
– Batch Records
7) Reference, if any
– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
– ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
8) SOP Version
Version 1.0
