4 – Supply Chain / Manufacture / Process Validation2018-03-14T14:57:47+00:00

Operations Control

GPB provide support to implement effective operational controls, to demonstrate compliance and enhance efficiencies.

woman in a lab coat working with device

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

  • Planning

  • 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

  • Standard Operating Procedures
  • QMS Standards
  • Manufacturing Instructions
  • Supplier Evaluation and Selection
  • Quality Agreements
  • Technical Agreements
  • Fulfilment Agreements
  • Design Transfer
  • New Product Introduction
  • Manufacturing Specifications
  • Process Definition & Control
  • Process Validation
  • PFMEA
  • Environmental Control
  • Clean Room (Zone) Validation
  • Labelling
  • Packaging
  • Sterilisation
  • Release Control
  • Materials Selection
  • Materials Stock Control
  • Traceability
  • Inspection and Testing
  • Non-Conforming Product
  • Batch Records / Release Control

Would you like to know more?

We are here to help  you with any enquiries you may have, if you would like to speak to a member of staff, please fill out the following contact form or feel free to contact us on one of the following: