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.…
Category: GMP & Guidelines
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…
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…
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…
Water Qualification
Water is the most widely used raw material or starting material in the production, processing and formulation of pharmaceutical products. Planned, well-defined, successful and well-documented commissioning…
Near Miss
Near Miss A Near Miss is an unplanned event that did not result in an injury or property damage but had the potential to do so. Near…
Analytical Method Validation
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used…
Quality Policy
Quality Policy A quality policy is a brief statement that aligns with your organization’s purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to…
APQR- Annual Product Quality Review
The Annual Product Quality review (APQR) is an effective quality improvement tool to enhance the consistency of the process and the overall quality of the…
Quality Agreements – PART 2
Quality Agreement From a cGMP perspective, manufacturing activities are the most important element in a quality agreement. The most critical pieces are quality and change…
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