Design / Integrate the Quality Management System
Quality management systems which are compliant with regulations (both local and international), international guidelines and standards help the organizations to lead in the local market and compete globally.
Our experienced professionals from pharmaceutical industry are experts in establishing Quality Management Systems and have strong knowledge of current regulations, international guidelines and standards. They provide guidance in making an efficient quality management system through gap analysis, training documenting procedures and where required process reengineering.
Organization can opt to design their quality management system integrated or separately to be:
Consistent with PIC/S GMP Guidelines
Pharmaceutical Inspection co-operation/ scheme is the leading international organization playing an important role in development, implementation and maintenance of harmonized GMP standards and quality systems of Inspectorates in the field of medicinal products.
Compliance to PIC/S GMP guidelines means Quality Mnagement System is aligned with in internationally accepted Good Manufacturing Practices which is the backbone for success in international GMP audits and inspections.
Once your QMS is approved the regulatory authority of any of the PIC/S member countries; opportunities are open to export your medicinal products to all of them.
Compliance with WHO Prequalification
The World Health Organization has programs for prequalification of organizations providing pharmaceutical products and for pharmaceutical quality control laboratories. About the aim of its prequalification program; WHO says “The mission of WHO prequalification is to work in close cooperation with national regulatory agencies and other partner organizations to make quality priority medical products available for those who urgently need them.“
WHO has issued guidelines for organizations interested to get prequalified by WHO. These guidelines provide frameworks to establish management systems. These management system helps the organization to offer products and services meeting internationally acceptable standards of quality.
Laboratory System Compliant With ISO/IEC 17025
The International Organization for Standardization in collaboration with the International Electrochemical Commission established the standard of competence for testing and calibration laboratories. The first edition of ISO/IEC-17025 in 1999. The second edition was introduced in 2005. Currently the third edition; published in 2017 is in place.
Accreditation to ISO/IEC 17025 is beneficial through Increasing reliability and global acceptance of test and calibration results, demonstrating laboratory’s competence, saving resources, and increasing customer satisfaction.