USFDA

Supporting Clean Areas & Clean Areas Separation in Aseptic Product Manufacturing – USFDA

Supporting Clean Areas Supporting clean areas can have various classifications and functions.  Many support areas function as zones in which nonsterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred.  These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological …

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-¬† The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification( OOS ). We have seen in last …

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out …

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What is Data Integrity In Pharmaceutical Industry…???

What is Data Integrity In Pharmaceutical Industry…??? MHRA says,”The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, …

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