Regulatory Management Policy

  Regulatory Work Plan The Regulatory Work Plan is to direct organizational resources to assure compliance…

Vendor Qualification (VQ)

VQ : Vendor qualification is the process by which a vendor is evaluated to determine if it…

Analytical Method Transfer (AMT)

AMT : It is the Documented process that qualifies a laboratory (receiving laboratory) to use an analytical method that…

Sampling tools

Scoops / Spatula Small containers of solid materials may be adequately sampled using a spatula or…

Water Qualification

Water is the most widely used raw material or starting material in the production, processing and…

Near Miss

Near Miss A Near Miss is an unplanned event that did not result in an injury or property…

Analytical Method Validation

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable…

Quality Policy

Quality Policy A quality policy is a brief statement that aligns with your organization’s purpose and strategic direction,…

APQR- Annual Product Quality Review

The Annual Product Quality review (APQR) is an effective quality improvement tool to enhance the consistency…

PART -2 Quality Agreements

Quality Agreement From a cGMP perspective, manufacturing activities are the most important element in a quality…