Description
The pharmaceutical products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or G(QC)LP. Regulatory authorities inspect laboratories to confirm that they meet the standards. This course explains how to comply with G(QC)LP, and it provides advice on laboratory work in general.
This online course introduces students to the basic requirements and concepts of quality control in a regulated pharmaceutical laboratory. It discusses issues that laboratory auditors focus on. Also presented will be particular pharmaceutical regulatory requirements, including, but not limited to, current good automated laboratory practices, the handling of specific conditions, and requirements for investigation of specific conditions. There will be a review of the current guidelines published by the FDA and other global regulatory agencies.
