What Is TQM?
A core definition of total quality
management (TQM) describes a management approach to long–term
success through customer satisfaction. In a TQM effort, all
members of an organization participate in improving processes, products,
services, and the culture in which they work.
Regulatory Work Plan
The Regulatory Work Plan is to direct organizational resources to assure compliance of regulatory activities &
the most effective work practices.It must
include resource allocations to the support of all Product Development
It shows the relationship among management processes, operational processes & support processes , ultimately affecting on patients & health institutions.
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Assurance” is the sum total of the organized arrangements made with the object
of ensuring that all drug substances & drug products are of the quality
required for their intended use and that quality systems...
VQ : Vendor qualification is the process by which a vendor is evaluated to determine if it can provide the necessary goods or services to the standards that the purchasing company requires.
AMT : It is the Documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that originated in another laboratory (transferring laboratory), whether that is internal or external to the receiving laboratory.
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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.
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...