1. Purpose of Operational Qualification of Dissolution Tester
The purpose of this Standard Operating Procedure (SOP) for Operational Qualification of Dissolution Tester is to establish guidelines for the operational qualification (OQ) of the Dissolution Tester within [Company Name]. This procedure ensures that the Dissolution Tester operates accurately and reliably, meeting regulatory and quality standards.
2. Scope of Operational Qualification of Dissolution Tester
This SOP for Operational Qualification of Dissolution Tester applies to all personnel involved in the use, maintenance, and qualification of the Dissolution Tester within [Company Name]. It encompasses the procedures for OQ, acceptance criteria, performance verification, and documentation.
3. Definitions involved in Operational Qualification of Dissolution Tester
3.1 Dissolution Tester:
An analytical instrument used for evaluating the dissolution profile of solid dosage forms, ensuring consistency and effectiveness.
4. Safety Precautions and Personal Protective Equipment (PPE)
4.1. PPE Requirements
4.1.1 Personnel conducting the Dissolution Tester OQ must wear appropriate PPE, including lab coats, safety goggles, and gloves.
4.1.2 Ensure that PPE is in good condition and properly fitted.
4.2. Chemical Safety
4.2.1 Handle any chemicals or substances involved in the qualification with care, following manufacturer instructions and safety data sheets.
4.2.2 Store chemicals in designated areas away from incompatible substances.
5. Equipment and Materials
5.1. Dissolution Tester
5.1.1 Ensure the Dissolution Tester is in proper working condition, with all components properly installed and connected.
5.1.2 Verify that the dissolution vessels, paddles, and other accessories are clean and free from residues.
5.2. Calibration Standards
5.2.1 Ensure the availability of calibrated standards appropriate for the Dissolution Tester OQ.
5.2.2 Calibration standards should have certificates of calibration traceable to national standards.
6. Operational Qualification Procedure
6.1. Test Parameters
6.1.1 Review the operational qualification plan to identify the specific parameters to be evaluated, which may include paddle speed, temperature control, and sampling methods.
6.2. Test Setup
6.2.1 Ensure that the Dissolution Tester is placed on a stable surface in a controlled environment.
6.2.2 Install the dissolution vessels and paddles according to the manufacturer’s instructions.
6.3. Performance Verification
6.3.1 Conduct a series of performance tests, including:
a. Verification of paddle speed.
b. Temperature control accuracy.
c. Verification of sampling methods.
6.3.2 Record all test results and ensure that they meet or exceed predetermined acceptance criteria.
7. Documentation and Recordkeeping
7.1. OQ Records
7.1.1 Maintain detailed records of each OQ session, including the date, time, test parameters, test results, and any adjustments made.
7.1.2 Ensure that all records are signed, dated, and readily accessible for review.
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