Preparation of Inspections

The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives.

The implementation of a versatile and practical risk management policy, together with a Quality System that pursues continuous improvement and a solid organization.

GxP Compliance and Preparation of Inspections

Changes have been extended to the pharmaceutical industry worldwide

Nowadays, many companies must face new challenges and situations that arise from new business opportunities: the development of a new product, the opening of new markets in new countries or geographical areas, agreements with international companies for a project on a global scale… This results in the need to comply with new or different regulations, not previously considered.

Opening to other markets, either in Europe, USA, Asia-Pacific, the Middle East or Latin America, requires the need of compliance to high standards of cGMP and the success in the subsequent inspections, a pre-requisite for the approval of new activities or products.

GxP Compliance

The application of the ICH guidelines to pharmaceutical business processes enables the most effective integration of GxP compliance needs with business objectives. The implementation of a versatile and practical risk management policy, together with a Quality System that pursues continuous improvement and a solid organization “to manage the exception” are the basis of the new approach to compliance.

Balance Compliance and Quality

GxP Compliance Strategy

Rephine facilitates a methodology capable of creating, with a reasonable investment and availability of time and resources, a fully GxP compliance infrastructure, capable of successfully meeting the requirements of a future regulatory inspection or audit.

Balance Compliance and Quality

GxP Audit & Evaluation

Design and Development of Improvement Plans

Preparation & Regulatory Inspections and Customer Audits

Risk Management Policies and Procedures

Evaluation & Development of Quality Systems

Training

Facilities, equipment and critical utilities, analytical instruments have been qualified and validated according to the industry current practices and regulatory requirements.

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

Related Resources

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 ...

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.

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.

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 ...

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.

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

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 ...

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, ...

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. ...

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.

Email: [email protected]

Social:

REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

First Name

Last Name

Phone

Country

Company

Job Title

Interested In

Message

Marketing Opt In

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

Professional Services

After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.