Plan

• Planning
  • Describe the business objectives.
  • Define execution roles and responsibilities for meeting the objectives.
  • Delineate the “user requirements” for the facility and/or systems.
  • Establish the system boundaries and their deliverables in accordance with the objectives and “user requirements.”
• Supplier Management
  • Assess the capacities, capabilities and QA/QC procedures of facility, system, and materials Suppliers and Vendors.
• Training
  • Provide procedures and instruction in Good Manufacturing Practices (GMPs) to all personnel.
• Execution Monitoring
  • Manage the costs associated with acquiring materials and constructing the facility and/or systems in accordance with deliverables.
  • Track progress of delivering the facility and/or systems in accordance with the business objectives.

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 Design & Construct

• Design Development
  • Generate a Basis of Design with specific facility, system and/or equipment requirements.
  • Create overall facility design: Site Master plan and discipline drawings for civil, architectural, structural, mechanical, and electrical.
  • Engineer system schematic diagrams: BFD’s, PFD’s and/or P&ID’s.
  • Establish system and equipment layouts or plans.
  • Produce construction and/or fabrication specifications for the facility, systems, and/or specific equipment units.
• Design Review
  • Review compatibility of facility, areas, and rooms with the processes, systems, and equipment contained within them.
  • Evaluate, examine, and/or assess the design of the facility and/or systems to ensure they meet the user requirements and business objectives.
  • The evaluation/assessment should be performed in accordance with a prescribed procedure that is applied to all facilities and/or systems.
• Construction Review
  • Make visits and inspections of Vendor/Supplier manufacturing facilities.
  • Examine and endorse Submittal Information, Shop or Fabrication Drawings
  • Respond to Requests for Information (RFI’s) related to design interpretations, construction details, field modifications, etc.
  • Inspect construction site and monitor construction activities.
• Engineering Change Management
  • Attest/approve that the system deliverables are ready for implementation or construction.
  • Provide the means and methods to initiate, communicate, authorize, and record needed modifications to the system deliverables.
  • Ensure that modifications to the “approved” deliverables do not adversely affect the abilities of the facility or systems to meet the user requirements and/or business objectives.
• Documentation Control
  • Facilitates, guides, and trains personnel on the ECM procedures as well as maintains library or storage area for deliverables and documents.

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 Validate

• Commissioning
  • Test and prepare each system for Commissioning following its installation.
  • Confirm the readiness and verify the performance of each system.
  • Calibrate all instrumentation and “backup” all automation software.
  • Record and document all Start-up and Commissioning procedures.
• Calibration
  • Record and document all instrumentation calibration results.
  • Set-up calibration schedule to maintain accuracy of instrumentation.
• Turnover
  • Receive, review, and verify all required “Turnover” Package documentation.
  • Deliver Turnover Packages to Documentation Control for administration.
• Qualification
  • Develop, review, and approve Validation protocols for all GMP systems (note: non-GMP systems only require Commissioning).
  • Execute Qualification protocols for Installation(IQ), Operation(OQ), and Performance(PQ).

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 Operate & Maintain

• Operations Management
  • Direct the work of personnel and operation of equipment to manufacture “goods” in accordance with GMP, validation, and regulatory requirements.
  • Manage engineering changes (extension of ECM procedures) as needed to maintain regulatory compliance and to meet business objectives.
  • Develop and maintain process models to simulate different Operations scenarios that can be used prior to implementing a change.
• Performance Monitoring
  • Determine compatibility of new processes and materials with systems.
  • Analyze labor, materials, and equipment costs associated with Operations.
  • Monitor and document Operations performance to establish a “baseline.”
• Continuous Improvement
  • Use Statistical Process Control (SPC) and Six Sigma analytical tools to find and fix weaknesses in “baseline” performance.
• Preventative Maintenance
  • Develop and execute regular maintenance schedules for all systems to reduce costly, disruptive “unscheduled equipment downtime”.

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 Retire

• System Evaluation
  • Determine whether the economic costs associated with operating a system or executing a procedure are in keeping with the business objectives.
• Interim Remediation
  • With the impact on the “validation” status of a process in mind, decide if remediation, removal, and/or replacement of a system is appropriate.
• Decommissioning
  • Prepare a system for Decommissioning following the decision to remove it from operational and/or active status.
  • Confirm the readiness and verify that the system can be removed without impact to Operations and/or the “validation” status of a process.
• Removal and/or Replacement
  • Treat removal and replacement of equipment as two separate projects.
  • The removal project is the end of one GEP “Lifecycle” while the replacement project is the beginning of another.
  • Documentation Control categorizes and archives applicable documents for removed systems.

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