Empower Tip: Method Validation

In this tip, we revisit the topic of validating chromatographic methods using the Method Validation Manager (MVM) option in Empower.

Method validation is a regulatory requirement for all pharmaceutical companies. Every compliant laboratory must conduct validation studies to show that analytical methods generate accurate and reliable data. This is required for all methods that are used to confirm the identity, quality, purity, and potency of pharmaceutical products. The validation process is time-consuming and can be prone to errors. The MVM option for Empower organizes and streamlines the entire method validation process, from start to finish.

Some background information:

Depending on the method type (or the USP category), different tests need to be carried out. For example, Category 1 is for API assay and the tests to be carried out are accuracy, precision, specificity, linearity, and range. Category 2 is for quantitative & limit tests for impurities. Category 3 is for dissolution & drug release tests and Category 4 is for identification tests.

The workflow using the Empower MVM option is as follows:

A validation protocol method is created and approved prior to initiating any experimental work.

A validation study is created and executed. During this step, the results are compared to the acceptance criteria set in the validation protocol.

Once the data is processed and reviewed, the results can be displayed in a report using report templates provided with the MVM option, which can be customized as needed.

A few things to do before we begin:

If you do not already have a license for the Empower MVM option, you need to purchase and activate the license for the MVM option for your Empower installation.

STEP 2:

You need to create two projects. The first project is a Validation Template project where you create the validation protocol. The Validation Protocol defines the tests to be run, the data to be acquired for each test, and the acceptance criteria for each test. NOTE: More details on creating a validation protocol will follow in subsequent tips.

The second project is a Validation Working project where you create and carry out a validation study. The study is based on the validation protocol created in the validation template project. NOTE: More details on creating and carrying out the validation study will follow in subsequent tips.