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Pronova, Sandefjord, Norway
Completed: July 2000
Scope of Work: Protocols & Procedures, URS, VMPs, cGMP reviews, Impact Assessments, IQ/OQ Protocols, Audits
Project Value: £120,000
Type of Project: Validation Support – Process expansion project (K85)
Provision of validation documentation for an extension to an existing process. Generating policy documents, protocols & procedures to enable the principal contractor to demonstrate compliance with FDA regulations for impending client licence application.
Contact 
+44 (0)1489 614422 |
+1 908 429 9100 |
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Features:
- Validation Specialist integrated with client team
- High profile consultancy on validating an upgraded process
- Compiling a URS for the project principal contractor
- Writing of IQ/OQ protocols, in standard format, for others to execute.
- Upgrade client documentation files
- Provide cGMP and Validation training for principal contractor to carry out practical execution work
- Generate programme for validation work for client and contractor
- Generate Computer VMP for new process control system
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