GxP Compliance and Preparation of Inspections
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.
Since the FDA’s initiative ‘cGMPs for the 21st Century – A Risk-Based Approach’ in 2002, the pharmaceutical industry has changed significantly in many ways to achieve, more effectively, practically and sustainably over the time, the original and essential goal of GMPs: Protecting Patient Health.
These changes have been extended to the pharmaceutical industry worldwide, thanks to the ICH initiative and the issuance of the Q8, Q9, Q10 and Q11 guidelines.
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.
See also our Quality Systems development and TrackWise implementation services
The experience acquired by TDV in these cases, 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.
Since 1997, we have been supporting drug and medical device manufacturers and other key agents in the product value chain, improving their GXP compliance systems:
If you require more information about GXP compliance strategy, please contact to
Mª Àngels San