Validation Master Planning for a State of The Art Sterile Manufacturing Facility

Problem Definition

A large pharmaceutical conglomerate was establishing a brand new, state of the art sterile manufacturing plant.  The facility design had to comply with the requirements of the United States Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (JMHW) and the European Agency for the Evaluation of Medical Products (EMEA).  However, the effort had the following major stumbling blocks:

  • The timeline for getting the facility constructed, the systems commissioned and validated was very tight.
  • No compliance infrastructure existed for handling the compliance of the facility and its systems.
  • Due to the complexity and enormity of the facility, a large number of vendors were utilized for the different systems that comprised the facility. There was an urgent need for standardization of the vendors’ deliverables.
  • There was also the need to assess the vendors to ensure quality.
  • The systems that comprised the facility were state of the art with complex automation.  There was an immediate need for qualified personnel in Computer Systems Validation in a variety of areas namely:
    • Laboratory Systems.
    • Manufacturing Systems.
    • Utilities.
    • IT Systems.
    • Packaging Systems.
  • Due to the complex automation of the systems, a well established, risk-based, scientific approach was necessary to ensure the validation effort was compliant yet cost-effective.

ValiMation's Role

ValiMation was hired as the lead validation consulting firm for the facility validation effort and managed the project from start to completion.

To get a comprehensive grip on the entire compliance effort associated with the new facility, ValiMation developed an exhaustive Validation Master Plan (VMP) that covered all aspects of facility validation and compliance activities.  This VMP was principally authored by ValiMation and maintained throughout the lifecycle of the project, providing guidance for the new facility.  The VMP included:

  • Detailed project description.
  • Compliance infrastructure requirements that needed to be met.
  • Vendor management strategies.
  • Project management including roles, responsibilities, timelines, project frameworks, project controls etc.
  • Risk Management.
  • A detailed validation methodology and strategy for Direct Impact Systems.
  • A detailed commissioning methodology and strategy for Indirect Impact Systems.
  • Room certifications / facility qualification strategies.
  • Cleaning validation strategy.
  • Environmental monitoring strategy.
  • Process Filtration strategy.
  • Finished Product Testing strategy.
  • Personnel Training and Management strategy.
  • Process Validation and Media Fills strategy.
  • Etc..

Project Management Services

ValiMation also contributed to the project by managing the entire initiative.  This included managing budgets, timeline and coordinating the activities of the various vendors and service providers associated with the new facility.

Compliance Infrastructure Establishment

ValiMation laid the foundation for a smooth and compliant new facility project by establishing a robust compliance infrastructure program: This included:

  • Change Control Management.
  • Document Management.
  • Batch Records Management.
  • Maintenance Management.
  • Security Management.
  • Supplier Evaluation Program.
  • Materials, Warehouse and Distribution Management Program.
  • Material Destruction Program.
  • Training Management.
  • Network Infrastructure and Information / Data Management.

Vendor Management

ValiMation ensured that quality is built into the facility by ensuring quality is built into the vendors selected for the new facility.  This included the following activities:

  • Vendor assessments and supplier evaluations.
  • Platforms (hardware / software) standardizations.
  • Requirements development
  • Standardized, informative RFP development.
  • Turn Over templates establishment and enforcement across multiple system vendors.
  • Contractor / vendor training on applicable regulations and facility policies.
  • Construction material receipt and control.
  • In-Process construction inspections.

Validation and Commissioning

The last phase of the effort included the validation / commissioning of the facility, the various processes and the systems within it.  The validation effort included the following efficiency increasing factors developed by ValiMation:

  • Establishing sound templates and methodologies.
  • Establishing risk-based approaches to validation.
  • Leveraging FAT/SAT and vendor testing as much as possible.

ValiMation's Impact - Our Unique Value Proposition

  • Effective management of a variety of disparate vendors and overall project management.
  • Establishing vendor Turn Over Templates that increased information gathering for qualification and reduced the extent of testing by leveraging vendor testing and FATs/SATs.
  • Critical compliance know-how especially for a project of this magnitude.
  • Establishing risk based approaches to make validation a value-added, effective effort.
  • Qualifying / commissioning a wide variety of systems on a variety of technological platforms.
  • Establishing a comprehensive compliance infrastructure for the facility.
  • We bridged Technology, Compliance and all key aspects of a new facility project.