PharmaCore GMP Analytical

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PharmaCore GMP Analytical

• Your Source for Trusted Support

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PharmaCore GMP Analytical

• Full integration with PharmaCore chemical
  production
• Analysis of Starting Materials, Intermediates,
  and Final Products
• In-house workflow adds efficiency resulting in
  shorter timelines to end state

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PharmaCore GMP Analytical

• Analytical projects from limited to large scope,
  long-term to short
• Expertise in both compliance and research

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PharmaCore GMP Analytical

• Mark Shapiro, Director
• Mark Shapiro is an innovative research scientist
  with a unique and broad 29 year record of
  achievement in both the prescription and OTC
  arenas. He oversees all GMP analytical chemistry
  including method development, raw material and
  intermediate release and API testing and
  approval. He formerly served as a Director of
  Analytical Resources and Global Reference
  Standards at Pfizer.

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PharmaCore GMP Analytical

• State-of-the-Art Analytical Facility

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PharmaCore GMP Analytical

• State-of-the-Art Analytical Facility

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PharmaCore GMP Analytical

• Analytical methods development, validation,
  transfer
• Analytical methods improvement (including
  cost-effective short column/solvent saving/faster
  methods)
• Residual solvents methods development/validation
• Extractables/Leachables testing

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PharmaCore GMP Analytical

• Stability storage and testing

ICH Q1A compliant chambers -20 Freezer 5
Refrigerated 25/60RH 30/65RH 40/75RH
Planned 3Q09 ICH Q1B Photostability
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PharmaCore GMP Analytical
Computer Data Management

• Agilent Enterprise Content Manager (ECM) System
• Fully Part 11 compliant
• Ensures data integrity
• Store/retrieve/report chromatographic and other
  instrumental data
• Manage SOPs (archive, schedule review)
• Instrument maintenance scheduling
• Chromatography Data System ChemStation
• Data has complete audit trail and is fully
  version controlled
• In-depth inspection of your data is a
  straightforward exercise