Quality

ORGANO PHARMA’s quality management system meets the requirements of both: cGMP regulations and ISO 9001, issue 2000 standards, and aims to ensure that the Quality of ORGANO PHARMA’s products are:

• Conforming to the updated specific requirements
• Safe
• Effective

 

ORGANO PHARMA’s quality management system is the way to keep our quality up. This goal is achieved only by building the quality into the product during:

• Planning of the infrastructure needed to achieve conforming to product requirements
• Planning to improve competence, awareness and training to ORGANO PHARMA’s human resources
• Customer communication
• Research and development
• Raw materials, packaging materials and other specific materials purchasing process
• Updating the technology and manufacturing techniques

 

ORGANO PHARMA’s quality management system is not only documented and implemented but also its effectiveness is continuously measured, analyzed and improved through monitoring and measuring of:

• Customer satisfaction
• Internal audits

 

ORGANO PHARMA’s quality management system promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. The quality management system identifies and manages numerous linked activities, each activity using resources and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The advantage of the process approach is that it provides the linkage between the individual processes; such approach emphasizes the importance of:

1. Understanding and meeting requirements
2. Obtaining results of process performance and effectiveness
3. Continual improvement of processes based on objective measurement