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Pfizer, Ringaskiddy, Ireland


Bulk Pharmaceutical Manufacturing Facility Support 
Completed: Ongoing from May2000
Scope of Work: VMPs, Gap Analysis, Impact Assessments, IQ/OQ Protocols, Change Control SOPs
Project Value: £200,000
Type of Project: Validation Compliance - Actives
 


Vessels


Overview:

First & second stage retrospective validation started in Operating Stream Processing Plant 2 to bring documentation up to a current validated state for impending FDA audit.  Gap analysis identified weaknesses on compliance that resulted in remedial compliance work to support client.

Features:

  • On-site team integrated with client team
  • Standardised protocol formats
  • Upgraded client documentation files
  • Consultancy on compliance matters
  • Utilised local Pettit resource to reduce cost
  • Ongoing work to 2003 to encompass OSP2 to a value of c£275,000

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