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.

GMP Audit Services

GxP Consultancy

Global Audit Library

Digitalisation

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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.