Define the documentation requirements
The customer’s quality procedures, validation responsibilities and approval process are established before work begins. Technical deliverables are scoped to support that process.
Equipment integration and technical support for pharmaceutical packaging environments, with defined responsibilities, controlled changes and documentation aligned to the customer’s quality system.
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Pharmaceutical packaging brings together container handling, labelling, coding, inspection and secondary packaging. A transfer adjustment or controls change can affect downstream checks. We review the equipment interfaces and define the records, tests and approvals with your engineering and quality teams before implementation.
The customer’s quality procedures, validation responsibilities and approval process are established before work begins. Technical deliverables are scoped to support that process.
Mechanical adjustments, controls changes and replacement components need a clear record. We coordinate with the responsible site team and identify required review and testing steps.
Product presentation, handling, line interfaces and changeovers are reviewed against the agreed formats and operating requirements. Acceptance and release remain with the designated customer stakeholders.
We work with your production, maintenance and engineering teams to agree the scope and the criteria for completion.
A few application details help us define a useful first technical discussion.
Discuss your applicationValidation protocols, qualification scope and production release are defined with your quality team. PrimeGear’s technical scope is agreed for each assignment.
New equipment, an existing line or a production problem. Tell us what you need to accomplish.