Validation of New Process

Process validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. FC-ValidationDownload

Sampling tools

Scoops / Spatula Small containers of solid materials may be adequately sampled using a spatula or scoop. The samples are then blended to provide a representative sample of that container. If the scoop used is...

Near Miss Report

Near Miss is an unplanned event that did not result in an injury or property damage, but had the potential to do so.  Near-Miss-FormatDownload

Bar code

What is Barcoding? The small image of lines, or bars, and spaces are affixed to nearly everything you can imagine, for identification purposes. Specifically, barcodes use a sequence of vertical bars and spaces that represent numbers and...

Quality Inspections

What are quality inspections?  Defining “quality” for an inspection system is not easy, because an inspection system is only one piece of a larger and complex legal system. At bottom, inspections are meant to...

Certificate of Analysis (COA)

General Requirements It has been recommended in various forums that the World Health Organization (WHO) should establish a model certificate of analysis (CoA) for use by quality control laboratories  and in trade in starting materials and finished pharmaceutical products...

Patent Registration in India

Patent is defined as a statutory privilege granted by the government to inventors, and to other persons deriving their rights from the inventor, for fixed years, to exclude other persons from manufacturing, using or selling...

HAZOP Methodology

A hazard and operability study (HAZOP) is a structured and systematic examination of a complex planned or existing process or operation in order to identify and evaluate problems that may represent risks to...

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