GLP & cGMP Method Development -Validation and Remediation

By: Pharma Tips | Views: 3016 | Date: 02-Sep-2011

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).

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)

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

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