Method Transfer & Validation

Method Validation is essential for adherence to Current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP). In order to meet these needs, we can assist you with method validation, method qualification and method transfer.

Analytical Method Validation (AMV) is a requirement within the biopharmaceutical industry for all methods used in testing raw materials, in-process materials, final containers and excipients.

Method Validation

Method Validation is used to confirm that the analytical procedure employed for a specific test is suitable for its intended use and is required for complete compliance with cGMP and GLP regulations, US FDA and international regulatory guidelines.

Some test method validation characteristics include:

• Optimization and development are largely completed prior to method validation studies
• Prior to validation testing, method performance is defined
• Requirements must be met by every validation trial run

Method Validation needs to be performed in situations including:

• Method transfer to different laboratory
• Validation prior to initial use of method in ongoing or routine testing
• Validation upon any changes to previously-validated conditions or method parameters, if changes extend beyond scope intended by original method
• Method is part of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission

Our team of experts can offer method validations services including but not limited to:

• Literature review
• Establishment of the intended use of the method and its performance requirements
• Development of a validation protocol
• QC and QA compliant execution of assays
• QC all data
• Optimize and finalize the test method

Phase Appropriate Validation

It may be acceptable to assess methods used for product characterization and comparability studies during early stage pharmaceutical development. Distinctions are not always clear; therefore we recommend you contact us for consultation on method qualification.

Phase Appropriate Validation characteristics include:

• Predetermined performance expectations of method
• Determine method performance elements such as specificity, linearity, accuracy and precision - for an intended application

Method Transfer

This can occur between laboratories and sites. This must be performed to ensure they maintain their validated state which ensures consistent results between laboratories Method transfer options include:

• Design of a method transfer plan
• Defining transfer tests and acceptance criteria
• Training of any relevant receiving personnel
• Execution of method validation tests and analysis in regulatory compliant laboratories
• Preparation of all method transfer documentation