Janssen Pharmaceuticals, a Johnson & Johnson Pharmaceutical company, conducts research and development activities related to a wide range of human medical disorders. Their mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. In more than 150 countries, they bring cutting-edge science together with the most creative minds in the industry to think differently about diseases. They are developing treatments for patients in five important therapeutic areas of healthcare: cardiovascular & metabolism, immunology, infectious diseases & vaccines, neuroscience, and oncology.

Modality Solutions was contracted into Janssen Pharmaceutical’s PDMS Primary Container group to assess the controlled temperature (passive) shipper qualification processes. Compared to best industry practices and regulatory expectations, a recommended mitigation list was created to close the identified gaps.

After completing an assessment of Janssen policies and procedures regarding current methods, Modality Solutions offered recommendations for improvement, as well as provided support and program management for the qualification of passive shippers.

Objectives included:

  • Revise work instructions on justification, and update current justification documentation to ensure consistency and compliance for passive packaging qualification
  • Create an SOP for qualification; update and change passive thermal packaging systems (lifecycle management of passive shipping system) as well as a work instruction for BLA submission support
  • Enhance database of existing passive thermal packaging qualifications
  • Create a RACI/approval matrix for all documents and identify appropriate internal resources for reviews and approvals
  • Manage all program activities for temperature sensitive products from clinical to commercial with respective project teams

Value to Company
The completion of the following deliverables helped determine measures of success:
  • Assessment report on policy and procedures with identified gaps and recommendations for improvement
  • Updated policy and procedure documentation to meet all approved recommendations
  • Change Control Record that identified required actions and time-bound implementation plan
  • SME support for leveraging existing qualified solutions as well as new shipper design
  • Updated qualification packages to meet current standards

The detailed approach on the assistance that we provided to Janssen included:
  • Use of Six Sigma tools and techniques to (1) create problem statements from Janssen Engineers comments, (2) translate them further into categorized needs, and (3) from those listed needs, create actual mitigation activities. The tools and techniques used were Voice of Customer Interview, Affinity Diagraming, and Cause and Effect Matrices. QMS documents, Global Standards, Standard Operating Procedures, and Work Instructions were reviewed for the aspects of compliance, efficiency and effectiveness, regulatory requirements, and best industry practices. The comments have been summarized and translated into opportunities to improve the QMS.
  • A review of the original qualification work has been performed to evaluate if the original test packages meet the requirements of current practice and determine any necessary testing outcome.
  • Value stream mapping was used as a lean-management method for analyzing the current state of the process and using the data to design a future state. The value stream map provided information about the time required to carry out each process step and classified the time into three main categories: value added activities, value enabling activities, and non-value added activities.
  • All program activities for temperature sensitive products from clinical to commercial with respective project teams were effectively managed.

With the conclusion of these exercises, critical gaps were identified within the shipper qualification processes, and a recommended mitigation list was created to close the identified gaps. We noted leveraging existing and qualification of new solutions. It was determined that passive shipper qualification should take a product-neutral approach instead of a product specific and clinical phase specific approach to improve the qualification process in terms of value and efficiency. The re-execution and revision of the current qualification reports will ensure regulatory compliance and create a universal product shipping portfolio. With a ‘universal’ platform approach for shippers, a requalification or revision of all reports following a standard report template with best-demonstrated reporting approach will provide a consistent agency review.