Quality Managment
Quality management is critical for the success of launching a biologic drug product.
Quality management starts from the very early stages of the development (Q8-Q10) with the risk analysis and up until the commission of a manufacturing facility. Our team has the experience and knowledge in establishing and reviewing all aspects of erecting a cGMP manufacturing facility such as:
• Project Management Plan (PMP)
• Commissioning Qualification Verification Validation e.g. VMP (CQVV)
• Process validation, Process Risk Analysis (Q8)
• SOP’s
• DQ, IQ, OQ, PQ, FAT, SAT
