Regulatory Compliance - Integrated Project Services - IPS
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Regulatory Compliance

As pharmaceutical manufacturing evolves from an art to a science and engineering based activity, application of this enhanced science and engineering knowledge in regulatory decision-making, establishment of specifications, and evaluation of manufacturing processes should improve the efficiency and effectiveness of both manufacturing and regulatory decision-making(1).

The evolving CGMP requirements for product quality assurance are driving a focus on quality risk management through increased process understanding.  This science and risk-based approach can reduce process variability, improve productivity, and promote continuous improvements in pharmaceutical manufacturing through effective process validation. Project quality must be design and built-in.

1 U.S. FDA, Pharmaceutical GMPs for the 21st Century – A Risk-Based Approach, Final Report, September 2004

IPS is well-positioned to apply this process understanding to the design, construction, commissioning, qualification and validation for new and renovated manufacturing facilities.  Our team has the industry experience and expertise to apply our process science and engineering knowledge across all stages of process validation.  IPS has especially deep knowledge process qualification, facility design and qualification of equipment and utilities and an understanding of how these factors relate to product quality.  In addition, our team of scientist and operations-experienced subject matter experts continue to provide product development and technology transfer expertise to help our clients define their processes, facilities and systems with the end-goal in mind; a fully operational and compliance commercial operation.

From our portfolio of projects around the world, we have developed broad expertise in worldwide regulatory expectations; where they have been harmonized and where they have not.  We explore the nuances of the regulations for the markets that will be served and can tailor our project deliverables accordingly to clearly meet regulatory expectation that facilities and equipment are"fit for intended use", consistently producing quality product and therefore, speeding the time to reach the market.

Global Regulatory Compliance Subject Matter Expertise

  • Regulatory Risk Assessments
  • Process Mapping (application of QbD, definition of CQAs, CPPs, CMAs)
  • Product Quality Risk Assessments
  • GMP Facilities and Equipment Design and Construction (API, OSD, Biotechnology, Sterile Regulations, Industry Guides and Technologies)
  • Commissioning and Qualification of Facilities, Systems and Equipment 
  • Validation
  • Manufacturing Controls and Procedures 
  • Inspections and Audits
  • Quality Risk Management
  • Technology and Manufacturing Site Transfers

Service Offerings

  • Assist with Filling Related to Facility/System Changes, Site Transfers and Process Changes
  • Preform Risk Based Regulatory Assessments/Audits for Existing Facilities, CMOs and Suppliers
    • Complete Due Diligence Inspections
    • Lead Mock Pre-Approval and Periodic Inspections
    • Preform CMO and Supplier Assessments/Audits
  • Assist with Filling Related to Facility/System Changes, Site Transfers and Process Changes
  • Conduct Product Quality Risk Assessments
    • Particulate Matter
    • Bioburden
    • Chemical Cross Contamination
    • Changes to facilities, Systems and Equipment
  • Apply QbD to streamline the engineering, qualification and validation processes
  • Design and Construct CGMP Facilities and Equipment
    • Develop Requirement Specifications
    • Perform CGMP Design Reviews and Design Qualification
    • Compose Position, Approach and White Papers
    • Type C Meeting Guidance and Assistance
  • Commission and Qualify Facility, System and Equipment
    • Develop CQV Execution Plans
    • Develop and Execute IQ/QQ/PQ Protocols
    • Perform Temperature Mapping
    • Consult on Environmental Monitoring
  • Perform Validation Activities
    • Write and Execute Cleaning, Sterilization, Process, Analytical Methods, and Computer System Validation Master Plans and Protocols
    • Provide Project Management and Project Controls
  • Perform Inspections and Audits
    • Complete Due Diligences Inspections
    • Lead Mock-Pre-Approval and Periodic Inspections
    • Perform CMP and Supplier Assessments/Audits
  • Quality Risk Management
    • Implement Risk Management Programs
    • Assess Process/Product Cross Contamination Potential 
  • Train Personnel on:
    • Isolator/Barrier Technology
    • Risk Assessment Approaches and Methods
    • Implementation for ASTM E2500 Standard for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    • Streamlining the Engineering and Qualification Process

Mark Rezak, our subject matter expert in FDA, EMA and global regulations, has over 20 years of experience in the design, construction, commissioning and qualification of CGMP facilities and equipment. Contact him to learn more about how we can help you achieve your project goals.