GMP Facility Case Study

How Frontage Delivers Project Success

 

The following information outlines in general how Frontage has helped companies develop their facilities and products for international markets.

 

Activity Phases:

 

  • Gap Analysis/Concept Design
  • Facility Construction/Equipment Installations/IQ
  • Operational and Performance Qualifications
  • Quality System Development

      Total Timeframe for these GMP engagements ranges from 14-24 months.  Actual time depends on specific facility modifications required to bring to compliance and makeup of company personnel experience.

       

      Phase One: Business Strategy / Gap / Conceptual / Design

      Timeframe: 3-6 Months

       

      1. Evaluate current facilities and business practices

       

      • Management team core capabilities
      • Facility operating conditions
      • Quality Systems

      2. Renovate existing facility or build new?

       

      • Determine core functionality of new facility
      • Develop conceptual design
        • Target products and volume
        • Equipment selection

      3. Engage Engineering Firms

       

      • Plan facility layout and utility requirements based on concept
      • Develop detailed engineering plans
      • Solicit equipment bids

      Phase Two: Facility construction / Equipment Installation / Qualifications

      Timeframe: 6-15 Months

       

      1. Select Engineering & Construction companies

       

      • Evaluate bids & prior project experiences
      • Review detailed design drawings & specifications for international compliance
      • Select trade companies (electrical, pipe fitting, architectural, etc.) 
      • Initiate construction / renovation

      2. Equipment purchasing / install

      • Evaluate equipment vendors based on required capabilities / price
      • Utility systems (Compressed air, Purified water, HVAC components, etc.)
      • Process equipment
      • Purchase equipment
      • Conduct Factory Acceptance Testing / qualifications

      3. Oversee construction   

      • Monitor Installations for compliance to plan & specifications
      • Decontaminate new areas
      • Perform functional evaluations & installation qualifications (air balancing, leak testing, electrical supply checks)
      • Develop calibration system and certify instrumentation

      Phase 3: Facility Operational & Performance Qualifications

      Timeframe: 4-6 Months

       

      1. Utility System Validations

       

      • Develop Qualification / Validation Protocols
      • Conduct operations training & prepare SOP’s
      • Start up systems and make adjustments to ensure compliance to validation requirements
      • Perform Operational Qualifications / validations
      • Develop monitoring and maintenance protocols

      2. Equipment Qualifications

       

      • Complete operations training for process equipment
      • Develop operations SOP’s
      • Develop Qualification Protocols
      • Perform qualifications and generate IQ/OQ reports

      3. Operations Systems and Performance Qualifications

       

      • Design protocols to confirm operating restraints
      • Conduct performance tests to confirm production capabilities
      • Evaluate cleaning and preventative maintenance procedures with quality control evaluations (microbial and chemical)
      • Finalize operations systems and SOP’s
      • Implement preventative maintenance program

       

      Phase 4: Quality System Enhancement

      Timeframe: 4-6 Months

       

      1. Determine areas of improvement

       

      • Review Quality Assurance , Quality Control and Regulatory teams
        • Are they adequately staffed?
        • Is there leadership on the team that can make tough decisions?
      • Evaluate Quality Management System & bring to international standards
      • Set up global quality documents, including master validation plan, Quality system Equipment Qualifications

       2. Quality Control Laboratory

       

      • Ensure lab is properly equipped for release of raw materials and finished products according to USP and EP requirements
      • Bring lab systems & computer systems into compliance
      • Develop Documentation practices to ensure data integrity and reviews
      • Improve SOP system and develop Lab investigation procedures

      3. Quality Assurance

       

      • Develop Roles and Responsibilities for Quality leadership
      • Implement oversight of key areas
        • Validation & instrumentation team
        • Manufacturing review team
        • Documentation team
        • Inspection team and labeling controls
      • Finalize operations systems and SOP’s
      • Oversee implementation of control system