Method Validation & Verification

What Are Method Validation & Verification?

Method Validation & Verification are experimental processes of establishing that the performance characteristics of a method meet the requirements of the intended analytical application.

Methods can be developed in-house, adopted from the client, or transferred to a client’s designated laboratories. Method development by the J-STAR Analytical cadre of scientists typically occurs during process development. This work is performed as needed and in a phase-appropriate fashion prior to tox batch delivery. M]Method verification / validation occurs prior to the subsequent GMP delivery.

Method verification / validation protocols are prepared following a phase-appropriate strategy informed by the J-STAR in-house SOP, written according to ICH Q2 guidance and current USP Chapters <1225> and <1226>. These protocols are available to be reviewed by the client.

Method Validation

Method validation applies to newly developed analytical methods. Typical analytical characteristics evaluated during method validation may include:

  • Accuracy
  • Precision
  • Specificity
  • Detection Limit
  • Quantitation Limit
  • Linearity
  • Range

Robustness may also be determined during method development. Solution stability will be established to ensure that analysis can be conducted within a given time frame without stability issues.

Method Verification

Method verification applies to analytical methods described in USP-NF, EP or validated methods transferred from other labs. Method verification consists of assessing selected analytical characteristics to generate appropriate relevant data (as opposed to repeating the entire validation process).

Method Transfer

Method Transfer applies to analytical methods transferred between external laboratories and J-STAR Research.. This ensures that the receiving laboratory has the procedure, knowledge and ability to perform the transferred analytical procedure as intended. Method transfer may be performed and demonstrated in various ways, including:

  • comparative testing
  • co-validation between two or more laboratories
  • complete or partial method validation or revalidation
  • the omission of formal transfer, sometimes termed the transfer waiver.

The approach proposed by J-STAR will be subject to approval by the client.

J-Star Offers GMP and Stand-alone Options

The J-STAR Analytical and QC department provides method verification / validation / transfer as part of the GMP campaign. Stand-alone method verification / validation / transfer is also offered.