Elements of a GMP-Compliant Quality Control Laboratory
The quality control (QC) unit serves an important role in the (bio)pharmaceutical industry by assessing and measuring specific and pre-defined parameters to ensure the safety and quality of (bio)pharmaceutical products. Erroneous QC laboratory analyses may have dire consequences for consumer health if out-of-specification product is sold. Topics discussed in this course include an overview of regulatory requirements, QC laboratory activities including raw materials, in-process and finished product testing, and handling out-of-specification (OOS) test results. Equipment qualification, method validation, and vendor qualification will also be covered. Practical examples, case studies and hands-on activities will be used to illustrate FDA QC laboratory hot button issues and regulatory compliance as related to the GMP-compliant QC laboratory.