Фармацевтика Аналитика Акта

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Periodic or Skip Testing in Pharmaceutical Industry: Us and Europe Perspective

Useni 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. However, the implementation of PT for in-process testing of finished product can be undertaken only after seeking concurrence from the agency either during the review of a marketing authorization application or after approval of the application. A suitable supplement or variation needs to be submitted to the agency for its review if PT is to be implemented for in-process testing. This article explains the periodic testing/skip testing approach for in-process samples, APIs, excipients and packing materials.