GLP and cGMP Method Development, Validation and Remediation

Intertek has extensive experience in the development and validation of analytical methods across a wide technology scope to ensure they meet the requirements of current validation standards. Cost effective approaches to method remediation and validation ensure compliance throughout the product and process lifecycle.

GLP and cGMP Method Development and Validation

We provide method development and validation services for a wide range of analytical technologies, including the application of these technologies to pharmaceutical intermediates, APIs, formulations and finished products (pharmaceutical and biopharmaceutical).  Our compliance with both GLP and cGMP regulations enables Intertek to support all stages of pharmaceutical development through to manufacturing.  For specialist technologies validated methods can be employed to provide QC services.  Methods can be developed and validated in accordance with either client-specific protocols or internal SOPs, and all methods are validated to meet MHRA, FDA and/or ICH guidelines as follows:

• Specificity and selectivity
• Analyte Precision
• Intermediate Precision
• Linearity and Range
• Accuracy
• LOD / LOQ
• Ruggedness
• Standard and Sample Solution Stability
• Robustness (optional)

GLP and cGMP Method Remediation 

For established pharmaceutical products, the analytical methodology that supports the production and release should undergo continuing review throughout the product’s life cycle, in terms of the validation status, efficacy and efficiency.  Working within the ICH guidelines Q2 (R1) specialist pharmaceutical analysts work in conjunction with QA to provide the following services for method remediation:

• Evaluation of existing analytical method validation to identify gaps and propose a remediation plan
• Assessment to predict the potential success of a validation against suitable acceptance criteria
• Optimization and modification of the method to ensure a successful validation
• Method Validation
• Method Transfer

Request more information to see how Intertek can help your organization with GLP and cGMP Method Development, Validation and Remediation.