{"id":83,"date":"2021-04-20T15:33:51","date_gmt":"2021-04-20T10:03:51","guid":{"rendered":"https:\/\/pvservicesindia.in\/?page_id=83"},"modified":"2021-04-23T00:19:31","modified_gmt":"2021-04-22T18:49:31","slug":"analytical-method-development-and-method-validation","status":"publish","type":"page","link":"https:\/\/pvservicesindia.in\/index.php\/analytical-method-development-and-method-validation\/","title":{"rendered":"Analytical Method Development and Method Validation"},"content":{"rendered":"\t\t
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<\/p>\n

Introduction:<\/strong><\/span><\/h4>\n

Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced.<\/p>\n

As more complex and diverse drug candidates enter the pipeline, developing reliable, accurate, and robust analytical methods to ensure quality and safety has become increasingly important. In parallel with product development, analytical development is a continuous refining process, in which product and process knowledge gained at each development phase can be utilized to optimize analytical methods. This continuous improvement approach is supported by regulatory requirements: analytical methods need to be qualified, but not validated until Phase II. Once the analytical methods are validated, the FDA expects them to be followed through the life cycle of the product.<\/p>\n

In this respect, analytical testing service is a long-term project. On the service sponsor\u2019s side, they are leaning more towards treating CROs as a strategic partner rather than short-term service provider. They are in favor of CROs that can provide integrated services, which allow them to reduce the number of vendors, streamline the process, and improve efficiency.<\/p>\n

PharmaVigil@<\/sup><\/strong><\/span><\/h4>\n

PharmaVigil@<\/sup> provides Analytical Method Development (AMD) and Method Validation (AMV) services.<\/p>\n

Development approach covers all aspects for the intended use of the method (stability indicating, process development support, limits of detection \/ quantitation, etc.).<\/p>\n

The extent of method validation studies are based on the stage of product development and comply with the industry guidelines.<\/p>\n

The analytical team in support of laboratory team establishes reference standards based on regulatory requirements thorough characterization and comparability establishment. The reference standards are then stored under cGMP conditions.<\/p>\n

For Analytical, Bio-Analytical, Bio-Pharmaceutical & Clinical methods to meet stringent regulatory forms, PharmaVigil@<\/sup> uses pre-qualified protocols based on regulatory norms of ICH, CDER, or CBER. These protocols can also be customized to meet client requirements.<\/p>\n

Our expert team has developed, validated and transferred more than 200 methods for clients.<\/p>\n

Our Capabilities:<\/strong><\/span><\/h4>\n

Custom Synthesis Capabilities \u2013 <\/strong>PharmaVigil@<\/sup> offers services in Process development for new products, developing Cost reduction process for Intermediates & API’s and custom synthesis of specialty chemicals and Pharmaceutical Impurities. Following are our expertise area in the custom synthesis-Small molecules synthesis<\/span><\/p>\n

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  • Drug and process development<\/span><\/li>\n
  • Impurity synthesis<\/span><\/li>\n<\/ul>\n

    Material Characterization <\/strong><\/span><\/h4>\n

    When it comes to understanding the physical structure, chemical properties and composition of materials, our company offers the breadth of experience, diversity of analytical techniques. We don\u2019t just perform testing; we drive commercial success through thoughtfully designed investigations, technically superior analyses and expert interpretation of data.<\/p>\n

      \n
    • Spectroscopy: FTIR, NMR (Liquid and Solid), Raman, UV-Vis<\/span><\/li>\n
    • Chromatography: GC, LC, GPC, IC<\/span><\/li>\n
    • Mass Spectrometry: LC\/MS, GC\/MS, Pyrolysis GC\/MS, MALDI<\/span><\/li>\n
    • Thermal: DSC, DTA, TGA,<\/span><\/li>\n
    • Elemental: ICP-OES, ICP-MS<\/span><\/li>\n<\/ul>\n

      Method Selection & Development Protocol:<\/strong><\/span><\/h4>\n

      Understanding the molecule chemistry and Method application area (routine quality control, stability indicating, screening methodology, confirmatory technique etc.)<\/span><\/p>\n

        \n
      • Method Evolution<\/span><\/li>\n
      • Identification \/ Detection Techniques – options and trade-offs; typical applications and sensitivities.<\/span><\/li>\n
      • Accuracy<\/span><\/li>\n
      • Precision<\/span><\/li>\n
      • Linearity<\/span><\/li>\n
      • Specificity & Resolution (Separations)<\/span><\/li>\n
      • Sample Preparation & Clean-up (if any) \u2013 options and trade-offs; typical recoveries and matrix-effects<\/span><\/li>\n
      • Optimizing systems<\/span><\/li>\n
      • Optimizing test procedures<\/span><\/li>\n
      • Determining LOD, LOQ, MDL<\/span><\/li>\n
      • Statistical validation<\/span><\/li>\n
      • Method Stability<\/span><\/li>\n
      • Robustness (system suitability, system component contributions)<\/span><\/li>\n
      • Measurement Uncertainty<\/span><\/li>\n<\/ul>\n

        Method Validation<\/strong><\/span><\/h4>\n

        PharmaVigil@<\/sup> designs the method\u2013validation protocols depending on the regulatory body to which the submission is to be made, and the nature of the method (Analytical, Bio-analytical, Bio-pharmaceutical,\u00a0Clinical). However some of the key steps are:<\/p>\n

          \n
        • Accuracy,<\/span><\/li>\n
        • Repeatability,<\/span><\/li>\n
        • Precision,<\/span><\/li>\n
        • Intermediate Precision,<\/span><\/li>\n
        • Reproducibility Precision\u00a0 (Inter – Analyst\/ Instrument\/ Laboratories),<\/span><\/li>\n
        • Selectivity,<\/span><\/li>\n
        • Specificity,<\/span><\/li>\n
        • LoD,\u00a0LoQ,<\/span><\/li>\n
        • Linearity,<\/span><\/li>\n
        • Range,<\/span><\/li>\n
        • Robustness,<\/span><\/li>\n
        • Response Factor<\/span><\/li>\n
        • Stability for all materials (Short-Term – Bench-Top + Auto-sampler, Long-Term, Freeze-Thaw Cycles), Sample Suitability,<\/span><\/li>\n
        • Method Comparability<\/span><\/li>\n<\/ul>\n

          Method Transfer<\/strong><\/span><\/h4>\n

          PharmaVigil@<\/sup> follows a step-by-step procedure to ensure that the methods developed or validated at our laboratory are seamlessly transferred to the client site. Some of the critical areas that our Method Transfer Protocol addresses are:<\/p>\n

            \n
          • Qualification of the Client Site (Receiving Laboratory) (Facilities, personnel, equipment, systems and procedures)<\/span><\/li>\n
          • Information Transfer (Procedures, Protocols, Precautions and Methods)<\/span><\/li>\n
          • Methods Familiarization (Demonstration, Operator Training and Troubleshooting on Client Site)<\/span><\/li>\n
          • Validation of the Transfer (Matching with pre-defined & agreed acceptance criteria, analysis of control & real-time samples, Method-Transfer Validation Report)<\/span><\/li>\n<\/ul>\n

            <\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

            Introduction: Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/full-width-page.php","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"medical-way-large":false},"uagb_author_info":{"display_name":"jain_avinash","author_link":"https:\/\/pvservicesindia.in\/index.php\/author\/jain_avinash\/"},"uagb_comment_info":0,"uagb_excerpt":"Introduction: Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is…","_links":{"self":[{"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/pages\/83"}],"collection":[{"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/comments?post=83"}],"version-history":[{"count":17,"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/pages\/83\/revisions"}],"predecessor-version":[{"id":243,"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/pages\/83\/revisions\/243"}],"wp:attachment":[{"href":"https:\/\/pvservicesindia.in\/index.php\/wp-json\/wp\/v2\/media?parent=83"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}