Service
Operational readiness
We prepare new facilities, lines and systems for compliant commercial manufacturing, from mechanical completion to the first commercial batch.
Operational readiness is the structured process of preparing a pharmaceutical facility, line or system for compliant manufacturing at commercial scale. We deliver complete readiness programmes that bring engineering, quality, operations and regulatory requirements into a single plan your site can execute.
Our technical director has led readiness programmes on sterile manufacturing sites in Europe and Australia. We use that experience to sequence the work and to plan for the issues that usually delay start up.
What we deliver
- Operational readiness master plan
- System readiness tracking
- Training programme development
- Standard operating procedure and batch record creation
- Regulatory submission support
- Pre approval inspection readiness
- Commissioning and qualification integration
- Punch list management and closure
At handover
What you receive
- Operational readiness master plan with system readiness status
- Approved standard operating procedures and batch records
- Training records for the operations team
- Pre approval inspection readiness assessment
- Closed punch list and handover documentation
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Risk based commissioning and qualification for filling lines, isolators, freeze dryers, sterilisation and clean utilities.
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View serviceEngineeringProcess engineering
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View serviceDiscuss your project with an engineer
Tell us the scope, the site and the timing. A director will reply within one business day.