Companies ramp up for the expected product approval during the commercialization phase of drug development. The manufacturing team completes line build-outs, in addition to process validations. Based on marketing sales forecasts, the manufacturing team also develops long-term purchasing plans. Training operators on new processes and equipment is another important function. Software for managing the training process helps ensure FDA compliance, which requires verification of training.
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As full-scale production gets underway, the quality assurance team implements the quality plan and begins playing an active role in making sure that all components, raw materials, and finished goods are in compliance with drug specifications. The quality team also investigates nonconformance issues, CAPAs, etc. MasterControl reporting and analytics software can help in this area, too, as can MasterControl process automation software, which automates the management of deviations, nonconformances, CAPAs, product changes, and supplier audits.
Controlled Documents Managed in the Commercialization Phase
Collaboration Workflows in the Commercialization Phase
For more efficient and effective training on SOPs and other regulatory guidelines, MasterControl provides:
To have complete details about pharmaceutical and biotechnical commercialization phase, feel free to contact MasterControl representative.