Method Development, Optimization, Validation & QC Release . . .

by UV, HPLC, LC-MS, or GC, GC-MS, ICP-MS Analysis

Analytical methods are critical tools for ensuring the quality, safety, and efficacy of drug substance (API) and drug product (FP) in the drug development and production process.

The goal of method development is to  ensure that the methods used to measure the identity, purity, potency and stability of drug substance (API) and drug product (FP) are accurate precise, and reliable.

Prior to starting any project, our Subject Matter Expert/s (SME/s) shall discuss the client’s project requirements to ensure an appropriate scope is defined.

We utilize our knowledge of method development on hundreds of products to assist with the development process.

Our laboratory scientist/s evaluate attributes such as precision, linearity, accuracy and specificity during development to ensure the method is suitable for validation.

Methods may be optimized for a variety of reasons, including improving separation of a critical peak separation, or supporting a formulation change. In addition, methods not validated to current industry standards may require optimization to allow for successful validation.

Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity and measurement uncertainty.

When a methods is submitted for qualification or validation, it is recommended to perform a feasibility study to assess its viability and to identify potential challenges and obstacles early on and develop strategies to mitigate risk/s.

Feasibility study allows gaining familiarity with the method and evaluate the method for attributes such as precision, linearity, accuracy and specificity and any other technical aspects required for successful project execution.

Method validation is the process of demonstrating that an analytical method is suitable for its intended use, and that it is capable of producing reliable and consistent results over time.

Methods are validated in accordance to the USP, EP, and ICH general chapters and guidelines.

Validation is performed under the direction of a protocol that outlines  the following components required to be successfully executed:

  • Accuracy
  • Precision
  • Specificity
  • Linearity
  • Range
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Ruggedness
  • Robustness

Analytical Method Transfer, USP <1224> is a documented process that qualifies a laboratory (i.e., the receiving laboratory) to use an analytical test procedure that originated in another laboratory (i.e. the transferring laboratory), thus ensuring the receiving laboratory has the procedural knowledge and ability to perform the transferred analytical procedure as intended.

We perform method transfers for both compendial and client methods to ensure the method is performed acceptably on your API or product matrix.

All method transfers are performed under the direction of pre-approved protocols at Shields Pharma.