Confidence Beyond Compliance

New Product Development (NPD) and New Product Introduction (NPI) encompasses the product lifecycle activities described in ICH Q10, and may be considered as a series of Technology Transfer Projects (PDA Technical Report 65 Technology Transfer). The NDP / NPI process describes the steps required for bringing the product from the development stage to commercialisation and incorporates stage gates for completion of Technology Transfer projects within the NDP / NPI process. Appropriate regulatory defined stage gates are also built into the NDP / NPI process, and are time dependent upon successful completion of new product development activities, clinical studies and activities for scale up and preparation for commercial manufacturing and distribution.

PharmaLex’s team of experts, which includes a number of former EU regulators, have the appropriate experience and expertise to provide services supporting the organisation in scoping and defining the NDP / NPI process for their organisation, including:

  • Mapping the NDP / NPI process from development through to commercialisation, including workstreams described in ICH Q10 for
    • Drug substance development
    • Formulation development (including container/closure system)
    • Regulatory and clinical strategy development
    • Clinical supply planning
    • Manufacture of investigational products to support the clinical program
    • Delivery system development (where relevant)
    • Manufacturing process development and scale-up
    • Analytical method development
    • Technical Transfers during development through manufacturing
    • Acquisition and control of materials for commercial manufacture
    • Provision of facilities, utilities, and equipment
    • Production (including packaging and labelling)
    • Quality Control, Quality Assurance and Release
    • Storage and Distribution (excluding wholesaler activities) and including Technology Transfer and Regulatory stage gates.
  • Defining the NDP / NPI activities in the NDP / NPI Roadmap which details the owner of the activity and the essential inputs and deliverables as required to support final regulatory approval for the new product and approval of the manufacturing facility.
  • Inputs and deliverables for the activities are defined for the purposes of;
    • Ensuring the accurate, clear and timely transfer of knowledge and technologies
    • Providing stage gates to be achieved in terms of progression to the next phase, i.e. are all inputs available, communicated and complete in order to initiate the next phase?
    • Ensuring deliverables are achieved before progressing to the next phase.
    • Ensuring GLP, GCP, GMP and GDP compliance across the NDP / NPI process, as appropriate to the stage in the project
    • Preparing and submitting IND, Clinical Trial, and Product License applications
    • Preparing for the facility Pre-Approval Inspection by the Regulatory Agency and
    • Providing for a fluid and efficient process which meets the regulatory stage gates in a timely manner
  • Identifying the Quality System procedure documents (SOPs etc.) needed to support each activity in the NDP / NPI Roadmap, and the documents required as inputs to and outputs from each activity, for example, protocols, reports or the validated analytical test method.
  • Providing guidance and training to the “Users” of the NDP / NPI process map and the NDP / NPI Roadmap.

This three-stage approach to the development and defining of the NDP / NPI process will

  • Provide the organisation with a path forward for ensuring all the documents and records required to support the NDP / NPI process are in place; all appropriate systems, documents and the Technology Transfer package are available to commence each of the NDP / NPI phases; and all appropriate documents and the Technology Transfer package identified as deliverables for each of the NDP / NPI phases are generated and allow progression to the next phase of the process.
  • Ensure appropriate Quality Management oversight of the NDP / NPI process.
  • Provide assurance of meeting the defined regulatory stage gates in terms of IND, Clinical Trial Application and Product Licence approval, and approval of the manufacturing site.