Equipment Qualification

Our experience in the qualification and commissioning of facilities and equipment is backed by years of successful inspections and audits

The methodology for commissioning and qualification is based on coordinated work with equipment and service suppliers, the engineering in charge and the engineering department of the property.

Commissioning and Qualification

Validation of a manufacturing process requires a suitably qualified operating environment.

This means good operational procedures, methods, instructions, trained personnel and a good qualification of the equipment, facilities and services involved in the process.

Qualification, carried out according to a methodology of risk management (ICH Q9) in order to focus on the critical aspects of each qualified element and, at the same time, to optimize time and resources, constitutes a key factor to provide the necessary evidence of knowledge and control of the equipment and of the process environment

Qualification throughout the entire lifecycle

Methodology

Rephine’s methodology for commissioning and qualification is based on coordinated work with equipment and service suppliers, the engineering in charge and the engineering department of the property.

In this way, we provide the client with the necessary experience and knowledge to meet their GMP compliance objectives in the design, commissioning and qualification stages. In addition we integrate quality in the project with validation activities, standardize quality standards and qualification documentation and optimize the resources of the Engineering departments.

We cover across the entire lifecycle of the qualification and commissioning of facilities and equipment which has been backed by our years of experience in successful audits and inspections

Design Review: conceptual design & detail
Preparation of Validation Master Plans (VMP)
User Requirements
Risk Analysis of Facilities and Equipment
Management of suppliers
Preparation and execution of qualification documentation

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

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