Transcription of FDA Guidelines-For Out of Specifications (OOS) In Industries
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FDA Guidelines-For Out of Specifications (OOS) In Industries
International Journal of PharmTech ResearchCODEN (USA): IJPRIF ISSN : , , pp943-948, July-Sept2013 FDA Guidelines-For Outof Specifications (OOS)In IndustriesG. Ravi,N. Vishal Gupta*,Raghunandan , Shashikanth. DPharmaceutical Quality Assurance Group, Dept. ofPharmaceutics,JSSC ollege ofPharmacy, JSS University, Sri Shivarathreeshwara Nagara, Mysore-15,Karnataka,India.*Corres. lies at the heart of drug manufacturer s successful operation. Laboratory testing, which isrequired by the CGMP regulations is obligatory to confirm thatcomponents, containers and closures, in-processmaterials, and finished products conform to Specifications , including stability Specifications . Testing alsosupports analytical and process validation efforts. CGMP regulations specifies that finished drug products thatfail to convene established standards, Specifications , or other relevant quality control criteria will be unexplained inconsistency of the failure of a batch or any of its contents to meet any of its specificationsandthat tests result that fall out ofspecifications (OOS) shall be thoroughly investigated, whether or not thebatch has already been
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.5, No.3, pp 943-948, July-Sept 2013 FDA Guidelines-For Out of Specifications (OOS)
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