Pharmaceutical / Biotechnical: Commercialization Phase

Learn How MasterControl Help Enterprises in Pharmaceutical / Biotechnical Commercialization Phase in Order to Support Cross Functional Teams

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.

Biotechnical Commercialization Phase Software Solutions

  • MasterControl Documents
  • MasterControl Collaboration
  • MasterControl Training
  • Other MasterControl Automation Processes

Controlled Documents Managed in the Commercialization Phase

Collaboration Workflows in the Commercialization Phase

  • Nonconformances
  • CAPAs
  • Validation testing protocols and reports
  • Clinical Trial Master File (CTMF)
  • Potential global submissions
  • Labeling and promotional materials
  • FDA correspondence
  • Quality plan
  • SOPs
  • Packaging and distribution plans
  • Long-term purchasing plans
  • Training records
  • Product sample plans
  • Market research and strategic plans
  • Product Launch plans: The product launch is developed and executed by the sales and marketing team, but requires the involvement of other departments as well. Discovery and development provide input on sales training documents, which require their scientific knowledge and understanding of the clinical data, while the regulatory and legal departments review and sign off on all launch plans.
  • Manufacturing and distribution: As the company builds out manufacturing for the product launch, decisions that drive expenditures, such as supply, capacity, and product shelf life, depend on collaboration between sales and marketing, manufacturing, and finance.
  • Commercial Materials: Product packaging, in both sample and stock bottles, UPC labeling, and package inserts must be circulated, reviewed, and approved by the marketing, regulatory, and management teams.
  • Collateral Materials: All product communication materials (which are generated by sales and marketing, with the assistance of scientific and development research) must be approved by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) before they can be used by the company's sales force. Prior to FDA submission, these materials are circulated and approved by various departments within the company, with legal and regulatory having final authority.

MasterControl Collaboration Software for Pharmaceutical Commercialization:

  • Provides a web-based, virtual workspace for collaboration.
  • Greatly reduces the need for face-to-face meetings among members of the sales and marketing, manufacturing, and finance teams as the company builds out manufacturing for the product launch.
  • Enables offsite members of the cross-functional team to collaborate on product launch plans, as well as communication materials, product packaging, etc.
  • The ability to chunk information for a particular audience or purpose facilitates collaborating on sales and marketing materials and scientific publications.
  • Creates system transparency, allowing authorized users to see where product launch plans, sales training documents, and other collaboration documents are in the review process.

Training/ Testing Software for Biotechnical Commercialization Phase

For more efficient and effective training on SOPs and other regulatory guidelines, MasterControl provides:

  • Secure, centralized repository for all training documents.
  • Automation of all processes related to training, including routing, tracking, escalation, and training verification.
  • Automatic grading of online exams; this serves as proof of personnel competency during inspections and audits.
  • Connectivity between document control processes and training. When a linked document is approved, training tasks for all affected trainees are automatically triggered.
  • Ability to sequence training courses so that, when a trainee completes a prerequisite, the next course automatically gets launched.

MasterControl Process Automation Software Needed During the Pharmaceutical Commercialization Phase:

  • MasterControl Change Control
  • MasterControl Training
  • MasterControl Nonconformance
  • MasterControl CAPA
  • MasterControl Deviations
  • MasterControl Audit

To Learn More About Pharmaceutical and Biotechnical Commercialization Phase

To have complete details about pharmaceutical and biotechnical commercialization phase, feel free to contact MasterControl representative.