Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients
نویسندگان
چکیده
منابع مشابه
The application of atomic absorption spectrometry for the determination of residual active pharmaceutical ingredients in cleaning validation samples.
The objective of this work was the development and validation of atomic absorption spectrometric (AAS) methods for the determination of residual active pharmaceutical ingredients (API) in rinse samples for cleaning validation. AAS as an indirect method for the determination of API in rinse samples can be applied when it is in the form of salt with metal ions or when the metal ion is a part of t...
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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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A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision. ross contamination with active ingredients is a real concern. The...
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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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Mislabeled examples in the training data can severely affect the performance of supervised classifiers. In this paper, we present an approach to remove any mislabeled examples in the dataset by selecting suspicious examples as targets for inspection. We show that the large margin and soft margin principles used in support vector machines (SVM) have the characteristic of capturing the mislabeled...
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ژورنال
عنوان ژورنال: Asian Journal of Pharmaceutical Research and Development
سال: 2018
ISSN: 2320-4850
DOI: 10.22270/ajprd.v6i3.371