Quality & Excellence:
At CSH Pharma Group, our mission is to provide quality medicines that help people lead healthier lives. Our intent is to create and maintain world-class business practices to ensure that our products are safe, effective and compliant with all internationally defined good practices. Our passion for quality goes beyond business and statutory requirements. We have only one focus – Patients.
Our commitment to implementing a robust quality management system based upon our desire to sustain a culture of operational excellence, meeting and exceeding the expectations of all stakeholders, including patients, customers and Government regulators.
We are committed to fulfilling the spirit and intent of our Quality policy where we manufacture, test and distribute pharmaceutical products. Our objective is sustained compliance with internationally defined good practices, collectively known as GxP. This includes Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP) and Good Pharmacovigilance Practice (GPVP).
Our commitment to GxP regulatory excellence supports our objective of providing safe and efficacious pharmaceutical products to our customers worldwide. Our alignment with these standards provides the assurance that patient safety is protected and that the data provided to the regulators is of the highest accuracy, integrity and quality.
We partner with our stakeholders to assure high quality development, manufacture and distribution of reliable and safe medicines through:
- Qualified, responsible, and motivated employees
- Integrity of our behavior and actions
- Effective and efficient GxP compliant quality systems
- Continuous quality improvement
We adhere to the following principles when implementing our Quality Policy:
- Individual Responsibility – Quality is a part of our culture at CSH Pharma Group. Every employee is focused on quality
- Management Responsibility – Management allocation of appropriate resources for effective implementation of all required quality management systems designed to support and sustain a culture of continuing GxP compliance and operational excellence
- Accuracy and Ethics – Every employee shall generate and accurately document all required quality data in accordance with the highest ethical standards and CSH Pharma Group’s Code of Conduct principles
- Continuous Improvement – Quality performance indicators shall be measured and assessed with outcomes designed to drive continuous improvement in our quality systems and employee performance
Our quality Management comprises both Quality System Controls and Quality Management Controls.
Quality System Controls
Quality System Controls assure that the development, manufacture, release and distribution of drug products take place through well-defined and well-documented quality systems and procedures.
Key elements for Quality System Controls include:
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Controls Systems
- Quality Systems
Quality Management Controls
Quality Management Controls enable us to proactively analyze and manage the performance of our Quality system. Our Quality Management Controls include QA/GxP processes for:
- Resource Management
- Employee Training
- Quality and Compliance Data Trending and Analysis
- Quality System Management Reviews
We ensure that the processes of our business partners comply with national and international regulatory standards that are in alignment with those of our own. We have implemented a well-defined and thoroughly documented set of quality systems and procedures for our business partners.
Quality means continuous improvement. Our Global Quality Standards are constantly bench marked against best practices and so these are continually upgraded to keep pace with the changing dynamics of the global environment.
We remain committed to the highest levels of professionalism and integrity and will ensure that all our facilities continue to meet the exemplary standards that are expected of a global pharmaceutical company.