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Method Validation, Verification, and Transfer: Parameters and Acceptance Criteria in Pharmaceutical Quality Management

 In the pharmaceutical industry, accurate and reliable analytical methods are critical for ensuring product quality and regulatory compliance. This post discusses the essential concepts of method validation, verification, and transfer, along with the required parameters and acceptance criteria. 1. Method Validation Definition : Method validation is a process of establishing that an analytical method is suitable for its intended purpose. This ensures that the method is reliable, reproducible, and accurate, helping to confirm the quality, safety, and efficacy of pharmaceutical products. When to Perform : Method validation is required for new methods, for methods that undergo significant modification, and for regulatory compliance, such as method registration or as part of Good Manufacturing Practice (GMP) requirements. Key Parameters for Validation : Accuracy : Determines the closeness of test results to the true value. Accepted typically within ±2% for AP...
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How to perform specificity during method validations?

  Specificity is one of the method validation parameter. Specificity defined by ICH Q2(R1), is as below, “Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.” So in the  context of specificity, the interested component must get explicitly assessed in presence of other sample components. To explain it further, let us take an example of a finished product such as tablets. Test solution of tablets consists of interested compounds (such as API and impurities) as well as the components which are of no interest (such as excipients). The excipients, though they are of no interest, one can’t completely remove them from test solution and hence it is important to assess their impact on quantification of analyte. Also, in case of assay analysis, the impurities will become the components of no interest and one must assess impurity interference while performing specificity. Let us understand how specificity is co...
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Potentially genotoxic impurities (PGIs)

ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now fully implemented and makes available a variety of approaches to control potentially genotoxic impurities (PGIs) based on the maximum daily dose, duration of use, and indication of the drug product. The limit to which a PGI is controlled, based on these factors is defined as the threshold of toxicological concern or TTC.   Once the need for control of a PGI is identified and the standardized deficiency from DLAPI is issued, a firm can use any of the following approaches as a control strategy in their response:  1) Use Options 1-4 provided in ICH M7 2) Provide negative (Q)SAR data 3) Provide a complete AMES study This poster provides a survey of the choices DMF holders have submitted to the Agency to control PGIs based on ICH M7.  Click here to view more
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