AMRITA SHETTY

  Analytical method validation as per   US-FDA (Part.:I) by Amrita Shetty, 03/04/2021        I.           I.  Reference standard & material.: Standard for use must be suitable. It should follow storage, usage condition, handling instruction for reference standard to avoid modification & contamination which lead to additional impurities and inaccurate analysis. This should be supported by qualification test report, certificate of analysis (COA) which include stability protocol, reports, and impurity profile information. This is often obtained from USP, European Pharmacopeia, Japanese pharmacopeia, World Health organisation or National institute of Standard and technology The standard for biological product is obtained from CBER. Reference material suitability is determined is not really captured by Drug product or product release test are ·          Extensive structural identity ·          Potency ·          Purity ·          Impurities Reference standa

Analytical method validation as per US-FDA by Amrita Shetty, 02/04/2021        I.             INTRODUCTION 1.       Analytical method required during product and process development activities are discussed in FDA guidance for industry on Process validation: 2.       Analytical procedure verification or validation data should be submitted in the corresponding section of the application in the ICH M2 eCTD: Electronic Common Technical Document Specification 3.       United States Pharmacopeias/National Formulator (USP/NF) or a validated procedure submitted that was determined to be acceptable by FDA. 4.       To apply an analytical method to a different drug product, appropriate validation or verification studies for compendial procedure with the matrix of the new product should be considered. 5.       parameter that may be evaluated during method development are specificity, linearity, Limit of detection (LOD), Limits of qualification (LOQ), range, accuracy and Precision.