%0 Journal Article
%T Standard operating procedures (SOP) - Back Bone of Pharmaceutical Industries
%A Sanjay k Jain
%A Nikhil Bhatwadekar
%J Pharmaceutical Reviews
%D 2008
%I 
%X In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly these goals can be achieved by following certain sets of procedures called as ¡°Standard Operating Procedures¡± (SOP). Procedures are essential for any plant¡¯s effectiveness and efficiency, and they are regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP-required SOPs and that the average maintenance burden is 15,000 h per firm. A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre-determined specification and quality end-result.
%U http://www.pharmainfo.net/reviews/standard-operating-procedures-sop-back-bone-pharmaceutical-industries