Today, many companies should face up to situations new to them in having to deal with new business opportunities: the development of a new product, opening a new market in foreign countries, an agreement with a large company for a global scale business,…This entails the necessity of complying with new regulations that the company never encountered, simply because that need didn’t exist before.
The opening to today’s markets, including European, US, Asia-Pacific, Middle-East or Latinamerican markets involves full compliance to the applicable cGMP and the subsequent audits and regulatory inspections for approval of the intended activities.
Since FDA’s initiative in year 2002: ‘cGMPs for the 21st Century – A Risk-Based Approach’ many things have changed dramatically in the pharmaceutical business to better approach cGMP compliance in its original and essential objective: to protect patient’s health.
These changes have expanded to the pharmaceutical industry worldwide through the ICH ‘globalisation’ of the original initiative and the resulting guidelines: ICH Q8, Q9,Q10 and Q11.
The application of ICH guidelines to the pharmaceutical business processes can integrate, in the most effective way, the GMP compliance needs with the business objectives of the company. The implementation of a versatile and practical risk management policy together with a Quality System pursuing the continual improvement and a robust organisation in order to ‘manage the exception’ should be the enablers of the new approach.
The experience TDV has gained in such cases, for both primary and secondary manufacturing, has provided a methodology capable of producing, in a reasonable time and resources frame, an infrastructure for GMP compliance, able to successfully meet the requirements of the future audit or inspection.
- GMP Audit and Assessment
- Implementation of Improvement Action Plans
- Preparation of regulatory inspections (EU, FDA, China CFDA, PMDA,…) and customer audits
- Risk Management Policies and Procedures
- Implementation and assessment of Pharmaceutical Quality Systems
For further information about GMP compliance strategies, please contact: