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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

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

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

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

Related Resources

Doctor Article

Maintaining Data Integrity with Digital Validation

The importance of data integrity is a widely discussed issue. There has been a rise in regulatory bodies like the FDA and WHO auditors focusing ...
Read More
Femtech Header Blog

Shaping the Future of Femtech to Inspire Inclusion and Innovation

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.
Read More
3PARL QUALANDRE HEADER Article

3PARL® Consortium grows stronger with Qualandre’s emphasis on ethical conduct and trustworthiness

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
Read More
Unrecognizable lab worker inspecting blood sample under microsco Blog

Innovative Solutions for Cancer Diagnosis and Prevention

As we navigate the complexities of cancer care, there’s a shared commitment to driving change and ensuring equitable access to life-saving treatments. This year’s World ...
Read More
3PARL OWLPHARMA BLOG HEADER 1@300x Article

Owlpharma joins 3PARL® to propel mission for ethical GMP supply chains in Life Sciences

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.
Read More
Scientist chemist researcher doctor analyzing dna sample using medical microscope GxP Consultancy

Decoding the technological minefield – A tactical approach to maximising Life Sciences R&D Software implementations

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Engineer servicing server rows Blog

All change for computer software assurance in Life Sciences

Newly published FDA guidance on Computer Software Assurance (CSA), together with the second edition of the GAMP 5 guide, have shifted the emphasis away from ...
Read More
3PARL PHARMA AUDIT BLOG HEADER LR Article

Pharma Audit among newest members of the recently launched initiative 3PARL®

3PARL® consortium welcomes Pharma Audit in its mission to assure consistent high standard of GMP supply chain audits in the life sciences industry   Stevenage, ...
Read More
Clinical Trials Blog LR Blog

Navigating ICH E6 (R3) changes for GCP excellence with a digitalised QMS process

In the realm of clinical research, adhering to Good Clinical Practice (GCP) through the ICH E6 guidelines has become an essential part for global compliance. ...
Read More

Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us