27 ISSN: 2347-7881 PharmaTutor Magazine | Vol. 2, Issue 10 | magazine.pharmatutor.org Review Article Updated Review: Validation and Method Validation Parameters Paras Virani 1, 2 *, Hasumati Raj 2 , Vineet Jain 2 , Parul Jain 3 1 Research Scholar 2014, Gujrat Technological University, Gujarat 2 Department of Quality assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat 3 Department of Quality assurance, Maliba Pharmacy College, Bardoli, Surat, Gujarat *parasvirani@gmail.com ABSTRACT Validation is an act of proving that any procedure, process, equipment, material, activity or system performs as expected under given set of conditions and also give the required accuracy, precision, sensitivity, ruggedness. Validation parameter is used for establishing documented evidence which proves that performance characteristics of the method meet the requirements for the intended analytical applications. The goal of validation is to demonstrate that analytical results produced by the application of a particular method are fit for an intended purpose. In this review article we discussed about the validation and its important parameter. Keywords: Validation, Validation Parameters, Good Manufacturing Practices INTRODUCTION Method validation is the process of demonstrating that an analytical method is suitable for its intended use, and involves conducting a variety of studies to evaluate method performance under defined conditions. Validation is required for herbal procedure, new process and reaction, new molecules, active ingredients, residues, impurity profiling and component of interest in different matrices. An analytical methodology consists of the techniques, method, procedure and protocol. This methodology includes the required data for a given analytical problem, required sensitivity, required accuracy, required range of analysis and required precision to the analyst. The International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use [1] has developed a text on the validation of analytical procedures. The United States Food and Drug Administration (USFDA) have proposed guidelines on submitting samples and analytical data for methods validation. [2-5] The United States Pharmacopoeia (USP) has published specific guidelines for method validation for compound evaluation. [5] The word validation was not mentioned in the ĐuƌƌeŶt Good MaŶufaĐtuƌiŶg PƌaĐtiĐes ;ĐGMPsͿ of 1971, and precision and accuracy were stated as laboratory controls. The need for validation was implied only in the cGMP guideline of March 1979. It was done in two sections: (1) “eĐtioŶ Ϯϭϭ.ϭϲϱ, ǁheƌe the ǁoƌd ǀalidatioŶ was used and (2) section 211.194, [6] in which the proof of suitability, accuracy and reliability was made compulsory for regulatory submissions. How to cite this article: P Virani, P Jain, R Hasumati, V Jain; Updated Review: Validation and Method Validation Parameters; PharmaTutor; 2014; 2(10); 27-37