Operations Control

Supporting you design, develop and implement effective operational controls, to demonstrate compliance and enhance quality and efficiencies.

We can assist in any aspect of Operations Control including:

Manufacturing In-House:

  • Environment / Clean Room Validation / Control

  • Supplier Evaluation

  • Supply, Service & Quality Agreements

  • Materials / components specification definition & control

  • Equipment / Process definition, validation & control (See Verification & Validation)

  • Completing risk management & PFMEA

  • Planning manufacture

  • Completing assembly / manufacture / formulation Control

  • Validating packaging / labelling

  • Ensuring batch¬† / Lot identification / Traceability/ 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 commit to respond to you: please complete the following contact form or contact us on one of the following: