Removing the Headache from Dissolution Testing

Quality and Compliance – Where You Need Them Most

Pharmaceutical labs consider dissolution testing to be one of the critical steps in the drug development process. And it makes its impact at almost every step of the journey, from early product development to late-stage quality control.

Dissolution testing helps labs control key variables in the drug development process, enabling them to:

• Immediately confirm quality control.
• Include stability testing within strict, well-defined criteria for each drug.
• Validate the manufacturing process and confirm therapeutic equivalence.
• Ensure that the drug is still pharmaceutically active throughout its shelf life.

Choose the Right Dissolution Testing Method

Performance Verification Test (PVT)

Also known as chemical calibration, the USP PVT test measures the performance of equipment used in dissolution testing, helping ensure that the results you get reflect drug qualities rather than the condition of the test equipment. The test is an important part of dissolution instrument qualification as outlined in the USP General Chapter <711>.

Benefits of PVT:

• PVT is a holistic test that can show variation in multiple parameters at once.
• It can take into account “hidden” issues, like those in a testing environment.
• It’s a comprehensive approach to testing.

Mechanical Qualification

The use of the mechanical qualification/calibration method to satisfy the current Good Manufacturing Practice (cGMP) calibration requirement (§ 211.160(b)(4)) has been endorsed by the FDA’s Advisory Committee on Pharmaceutical Science (ACPS). The USP posted a toolkit to provide a mechanical calibration procedure, aligning with mechanical tolerances in USP <711> for dissolution apparatus assemblies. However, neither the mechanical tolerances specified in USP <711> nor the procedure described in the USP toolkit are as comprehensive or as stringent as those in the enhanced mechanical calibration procedure from the FDA.

Benefits of Mechanical Qualification (MQ):

• A robust Mechanical Qualification is essential to reduce the risk of non-reproducible dissolution tests.
• Chemical Calibration (PVT) using prednisone tablets requires expertise and is very time consuming. Failure is very common for first time analysts. This drawback is not faced with MQ.

For more on the challenges of dissolution testing – and the best practices to guarantee data integrity and compliance you can read our white paper here.