Dear Bloggers, Hello everybody....Please find my first blog for this month, in whcih I am going to provide a brief insight about Validation and its importance. And further in my subbsequent second blog I will highlight about types of validation, phases of validation and developing strategy for validation. The term Validation means an act of establishing and documenting that all the processes, systems, facilities, steps and equipments employed in the production of Pharmaceutical product are well controlled and maintained. All these factors ultimately influence the quality of the product, henceforth must be adequately monitored. The validation is very critical not only to establish that you are able to get a quality product, but at the same time to ensure that, by doing adequate and proper validation , you are able to produce consistent and uniform batches meeting the predetermined specifications. For e.g Validation of granulation process involves, broadly involves Equipment Validation, process validation and Final Product Granule validation (1) Now each and every validation required for the granulation process is further refined and systematic approach is developed by defining the parameters and predetermining the specification . For e.g. Parameters required to be validated in final granules validation are Granule flow, Bulk density, Moisture content, Particle size distribution (Sieve analysis and Granule crushing strength (2) Now the question arises, Do we need to validate all the processes, facilities and equipments .....?? Yes!! Validation is needed in all these system, facilites and equipments where by in each and every step, process should describe the output desired and for this output achievement , a predetermined specifications needs to be developed. Examples : Sterilization processes, Clean room conditions , Lyophilization process. etc Validation is something like without which Pharmaceutical Industry cannot breathe. It determines the quality of the product developed. Henceforth is should be critically studied, evaluated and analysed. Happy Blogging References 1) Nash R A., Wachter A.H., Pharmaceutical process validation, 3 rd edition,Marcel Dekker publication, p.g. no-xxx-xxxiv, 173-182. 2) N. K. Jain & S. N. Sharma, A Text Book of Professional Pharmacy, Vallabh Prakashan, p.g.no. -295-297 Note :"This Blog Does Not Contain Any Plagiarized Material"