Analytical Test Method Categories
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The categories of analytical test method categories for which validation data should be required are: Category I: Analytical methods for quantitation of major components of bulk drug substances or active ingredients (including preservatives) in finished pharmaceutical products. Category II: Analytical methods for the determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products. These methods include quantitative assays and limit tests. Category III: Analytical methods for determination of performance characteristics (e.g., dissolution, drug release). Category IV: Identification tests. Which Analytical Performance Characteristics are Required for each Analytical Test Method Category as per USP <1225>?For each analytical test method category, different analytical performance characteristic is needed. The following table describes which analytical performance characteristics is applicable to each analytical test method category:
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Three (3) Options to Create an Analytical Method Validation Protocol: Analytical Test Method CategoriesOption 1. You Can Create a Great Analytical Method Validation Protocol, Using a Template.You can download a free sample of a validation template in .pdf format. To see the complete list of the most popular validation templates, click here. In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill and adapt to your needs. Option 2. We Can Bring You a Formal Training on How to Select the Analytical Test Method Categories.This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections. It includes the template, an exam, and a training certificate for each assistant. Request a quote now. Option 3. We Can Create a Customized Analytical Method Validation Protocol.One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online. GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)References: Analytical Test Method Categorieshttpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1 Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for IndustryValidation of compendial methods |
Ramon Cayuela, MS, BS, Chemical Engineering
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