A REVIEW ON CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY
نویسندگان
چکیده
منابع مشابه
Determination of Residual Ceftazidime in Pharmaceutical Product line: A Cleaning Validation Study by HPLC
The manufacturing equipment in pharmaceutical industry, could be used in multiple and sharedproduction lines, therefore there is the possibility for the products components and active ingredients tointermix and pollute one another. In this purpose the cleaning methods are used, to reduce the residueslevels from the machinery surfaces and decrease the residues to acceptable level but these metho...
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Validation is a tool of quality assurance which provides confirmation of the quality in equipment system, manufacturing processes, software and testing methods. Validation assures the products with predetermined quality characteristics and attributes can be reproduced consistently/reproducibly with in the established limits of the manufacturing process operation at the manufacturing site. Valid...
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Alka Chadha (2008) This paper studies the impact of the strict patent regime on the patenting activity of Indian pharmaceutical firms and finds that patenting activity of these firms has increased after the signing of TRIPs. The study is conducted for 65 pharmaceutical firms for the period 1991 to 2004 using different parametric and semiparametric count panel data models. Results across differe...
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Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particle, dust, lubricants, raw materials, intermediates. Mainly cleaning is performed to remove product and non-product contaminating material. Ineffective cleaning can lead to adulterated pr...
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The present review article focus on introduction and general overview on process validation in pharmaceutical industry. The word validation simply means “Assessment of validation or action of proving effectiveness”. The process is developed in such a way that the required parameters are achieved and it ensures that the output of the process will consistently meet the required parameters during ...
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ژورنال
عنوان ژورنال: Journal of Drug Delivery and Therapeutics
سال: 2018
ISSN: 2250-1177
DOI: 10.22270/jddt.v8i3.1695