alexa Periodic or Skip Testing in Pharmaceutical Industry: Us
ISSN : 2153-2435

Pharmaceutica Analytica Acta
Open Access

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Review Article

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

Useni Reddy Mallu1*, Raman NVVSS2, Sachin RD1 and Anand K1

1 Department of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India

2 Hetero Drugs Ltd. (RandD), Plot No. B. 80 and 81, APIE, Balanagar, Hyderabad 500018, Andhra Pradesh, India

*Corresponding Author:
Useni Reddy Mallu
Sri Krishnadevaraya University Chemistry
Anantapur, anantapur, AP 500072, India
Tel: 9490310239
E-mail: [email protected]

Received date: December 16, 2013; Accepted date: January 17, 2014; Published date: January 23, 2014

Citation: Mallu UR, Raman NVVSS, Sachin RD, Anand K (2014) Periodic or Skip Testing in Pharmaceutical Industry: Us and Europe Perspective. Pharm Anal Acta 5:283. doi: 10.4172/2153-2435.1000283

Copyright: © 2014 Mallu UR, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

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.

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