GMP & Guidelines

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...

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...

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 and qualification is an essential precursor to successful validation...

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 miss, reporting is vitally important in preventing serious incidents that are less...

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 to judge the quality, reliability and consistency of analytical results; it...

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 meet applicable requirements (ISO 9001, customer, statutory or regulatory) as well as to...

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 product. APQR will capture a broader view of product...

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 control, as described in the following sections 2....