Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

Topics: raw materials requirements, cgmp requirements for raw materials, raw material testing requirements, raw material requirements in a cgmp environment training, compendial and non-compendial testing, ICH Q9, health canada requirements