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Raman NVVSS
Raman NVVSS
India
Publications
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Review Article
Periodic or Skip Testing in Pharmaceutical Industry: Us and Europe Perspective
Author(s): Useni Reddy Mallu, Raman NVVSS, Sachin RD and Anand KUseni Reddy Mallu, Raman NVVSS, Sachin RD and Anand K
Periodic Testing (PT) or Skip Testing (ST) is an important and widely discussed concept for the purpose of cost saving in the generic pharmaceutical industry where widespread expenditure is a necessity. As there is no particular/ appropriate/apropos guideline recommending the implementation of the PT or ST concept so pharmaceutical companies implement it depends on their vendor qualification procedure and other aspects. All pharmaceutical industries have their internal Standard Operating Procedure (SOP) for the implementation of periodic or skip testing. These tests can be implemented for Active Pharmaceutical Ingredients (APIs), excipients, packing materials and inprocess testing of finished products analysis. Implementation of PT or ST for API, excipient and packaging material can be approached according to SOPs which would be available for an audit by the regulatory agencies. Howev.. View More»