Operations Control
GPB provides support to implement effective operational controls, to demonstrate compliance and enhance efficiencies.

We can assist in any aspect of Operations Control including:
Manufacturing In-House:
Environment / Clean Room Validation / Control
Supplier Evaluation
Supply Agreements
Materials / Component Specification & Control
Equipment / Process Definition & Control (See Verification & Validation)
PFMEA
Assembly / Manufacture / Formulation Control
Packaging / Labelling
Batch Identification / Release / Records
Contract Manufacturing (including overseas):
As above
Selection & Monitoring
(See NCR / CAPA)
Preparation of Quality / Technical Agreements

Design / Develop
Risk Management
Audit & Monitor
Technical
Documentation
Change Control
Clinical Evaluation
Data Analysis
Doc & Data Control
Launch & Distribute
Management
Systems
NCR & CAPA
Ops Management
Performance Improvement
Regs & Standards
Reg Strategy & Plan
Reg Submission
Verification & Validation
Vigilance & PMS