Pharma Industry Guidelines

TOTAL QUALITY MANAGEMENT

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. TQM focuses...

Regulatory Management Policy

  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 activities from...

Path For Process Management

It shows the relationship among management processes, operational processes & support processes , ultimately affecting on patients & health institutions. Fc-Process-MgtDownload For any feedback or suggestions write to us at info@pharmastate.com

Quality Assurance

Introduction : “Quality 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...

Vendor Qualification (VQ)

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. FC-VQDownload For any...

Analytical Method Transfer (AMT)

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. FC-AMTDownload For any feedback...

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...

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