Quality Management System Guide
Being aware of the importance of maintaining the highest quality standards in obtaining Marketing Authorization and conducting clinical trials with medicinal products for human use, Smooth Drug Development is committed to implementing, maintaining and constantly improving effective Quality Management System (QMS) to pursue goals of its clients and shareholders.
The company's QMS is based on the requirements and guidelines as set out in the ISO 9000 family of standards, specifically international standard ISO 9001:2008 Quality Management Systems. Requirements, ISO 19011:2011 Guidelines for Auditing Management Systems, ICH Good Clinical Practice and other Guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The QMS takes into consideration special aspects of company operations and regulatory environment, which is reflected in respective sections of the QMS regulatory documents.
The top managers of the company are dedicated to developing, implementing, maintaining and improving the QMS.
The purposes of this QMS Guide are:
- To define the structure and principles of QMS implementation
- To describe general company management policy in the context of quality
- To identify key processes that need to be regulated by policies, operating procedures, guidelines etc.
- To describe processes designed to fulfill the QMS goals such as control and quality assurance
- To describe processes designed to maintain competence in relation to quality
- To describe processes designed to assess application, to maintain and evaluate the QMS
The aim of implementing of the QMS is to identify, harmonize, formalize, control and improve key processes intended to:
- Develop and use effective unified instruments contributing to standardization and control over the processes
- Create conditions ensuring that services delivered by the company meet regulatory requirements, industry quality standards and Clients' expectations
- Ensure legal, reputational and financial security and to achieve company’s and Clients’ purposes by strictly adhering to legal requirements and fulfilling contractual obligations