Future pharmaceutical industry in India

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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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Quality Management Systems in the Pharmaceutical Industry and Key Regulatory Guidelines

In the pharmaceutical industry, the importance of a robust Quality Management System (QMS) cannot be overstated. Quality assurance is not just about meeting standards; it’s about ensuring patient safety, product efficacy, and regulatory compliance at every step of the production and distribution process. A well-implemented QMS helps pharmaceutical companies achieve consistent product quality while also maintaining trust with regulators and consumers. Understanding Quality Management Systems (QMS) A QMS in pharmaceuticals refers to the comprehensive framework that ensures all processes involved in the production of medicines meet regulatory and customer requirements. It spans across product development, manufacturing, testing, distribution, and even post-market surveillance. This system is structured to identify potential risks, establish control measures, and promote continuous improvement. The key pillars of an effective pharmaceutical QMS include: Good Manufacturing Practices (GMPs) ...
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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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