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 & Regulatory Compliance, we’re the partner of choice for all the stakeholders we deal with.

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

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library

Regulatory

Regulatory

Related Resources

Article

ValGenesis & Rephine Partner to Deliver Digital End-to-End Compliance Solutions for Life Sciences Companies

The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …

Read More
Blog

EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …

Read More
SQA PR Article 1 Article

Rephine to sponsor forthcoming Global Quality Assurance Conference

Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity.   …

Read More
shutterstock 793279159 Blog

New EU GMP Annex 1 requirements: EMA says no deadline extension

An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …

Read More
Article

Preparing to meet EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products

Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …

Read More
Article

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by  Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …

Read More
Blog

The roaring 20s: what a time to be Life Sciences’ Quality backbone

Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …

Read More
Ebook

Practical Steps to Compliance with EU GMP Annex 1

About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …

Read More
Event

CPHI 2022 Golden Ticket

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

Telephone:

Rephine HQ, UK
+44 1763 853135

Barcelona, Spain                               +34 934 178065











    Rephine respects your privacy. Choosing to check the box means that you agree to the Rephine Privacy Policy. You can unsubscribe at any time.

    Newsletter