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Integrity Solutions Europe
T.
+44 (0) 20 8793 9531
F.
+44 (0) 20 8793 9531
E.
contact@integrity-solutions.co.uk
Integrity Solutions Japan
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+81-3-6420-0775
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+81-3-6420-0162
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contact@integrity-solutions.co.jp
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Testimonials

"Responsive, reliable and knowledgeable.  Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"
Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

  • Deployment and validation of multiple PAT analysers
  • PAT analyser integration with Global PAT management tool
  • Deployment across world-wide manufacturing and R&D facilities
  • Data management, integrity and security processes

OBJECTIVES

  • Enhance process understanding, streamline technical transfer, increase production throughput and reduce off-line laboratory testing
  • Meet regulatory expectations i.e. FDAs 21st Century GMP Guidance
  • Facilitate greater understanding of process design space through implementation of Quality by Design (QbD)
  • Ensure deployed technologies are validated and supported

ROLE

  • Determine PAT techniques that yield maximum benefit
  • Design integration of PAT toolset with production processes
  • Validate PAT toolset
  • Facilitate senior management commitment to PAT proposals and deployment of improvements
  • Update QMS policies/standards/processes to adopt PAT

OUTCOMES

  • Greater understanding of unit operations
  • Increased manufacturing throughput
  • Reduced reliance on laboratory confirmation testing
  • Reduction in failed batches leading to an increase in OEE

CHALLENGES

  • Integration with existing processing equipment
  • QMS policies/standards/processes not designed to work with PAT
  • Establishing cross functional / discipline teams
  • Engagement of Business ,  IS/IT and Quality leadership
  • Relationship and conflicts with parallel business initiatives

BENEFITS

  • Product quality and performance are assured
  • Product and process specifications based on formulation process understanding
  • PAT risk-based approach accepted by regulators
  • Continuous quality assurance, real time release possibilities