Quality

This package features a training presentation that outlines a standard procedure for aseptic gowning, as well as recommended cleanroom behavior for aseptic processing areas.

This training package features a comprehensive introduction to the CAPA (Corrective Action and Preventive Action) process.

This template package features a universal Analytical Assay Summary template that can be used to provide the most up-to-date information on all assays used for in-process testing, lot release, characterization, raw material testing, and other assays related to a specific process requiring technology transfer.

This training package features a training presentation which provides background information on microbiology and an overview of aseptic processing in GMP facilities.

This template package features a universal Bill of Materials template that can be used to provide the most complete information on all components, raw materials, consumables, reagents, and biologic materials.

This template package features a universal material receipt and lot testing template that can be used for receiving raw materials and executing incoming testing.

This SOP package features an SOP template that outlines the procedure for releasing incoming raw materials. A Material Receipt & Lot Testing template form is also provided.

This template package features a universal Sampling Plan template that can be used to provide information on quantity, size, and nature of samples of materials to be collected at various stages or unit operations for process control, release, or informational purposes. This template is especially useful for technology transfers.