Quality

Quality assurance is the heart of our success strategies. It is our commitment and approach which being integrated into every step of our daily business activities and applied with a comprehensive understanding and application of WHO-GMP (World Health Organization-Good Manufacturing Practices), to provide safe and premium products to our patients through:

• Effectively implementing the continuously developed quality and technical requirements for both inputs and outputs.
• Certification and rating of suppliers.
• Testing of procured materials to ensure conformance to our reliable Quality, Performance, and Safety Standards.
• Ensuring application of precise quality standards concerning receiving, storage and use of all production materials.
• Internal auditing of the production process at each phase, such as QC testing (Quality Control) and inspection of the finished product to ensure conformance to our Quality Standards.
• Evaluation of overall production process to establish required corrective and preventive actions and guarantee full implementation of our quality policy.

Orchidia has expanded its quality perspective to adopt quality as a culture. The quality culture helps to encourage continuous improvement of processes through sharing patterns of beliefs, values, attitudes, and behaviors to characterize quality understanding and implementation of quality requirements. We have established specialized committees that include members of all managerial and staff levels such as Technical Committee, Quality Committee, New Projects committee, Formulation, and Product Follow up committees. The main objective of these committees is to review our performance periodically and make recommendations for improvement to meet customer needs, achieve effectiveness, efficiency and sustain competitive advantages. Therefore, we will be consistently achieving customer satisfaction and maximizing of stakeholders’ value.

Since our products have an important influence on patient lives and society, Orchidia applies QMS (Quality Management System) to meet the requirements of cGMP, ISO 9001:2015, 14001:2015, EMS, OHSAS 18001:2007, 13485:2012, MDSS (Medical Device Safety services) and the requirement of Directive 93/42/EC related to the manufacturing of medical device products.

Policy of Quality, Environmental and Occupational Health and Safety

As a leading pharmaceutical corporation in the field of manufacturing of ophthalmic products and contact lenses solutions, we recognize the value of customer satisfaction, environmental responsibilities, and safety of employees. Therefore we maintain and continually improve our QMS, EMS and OH&S systems to ensure they are fulfilling the required quality, environmental and occupational health and safety objectives.

To ensure exceeding our customers’ expectations, we perform all activities and operations according to ISO 9001:2015, EN ISO 13485:2016, ISO 14001:2015 and ISO 45001:2018 requirements.

To guarantee the implementation of our QMS, EMS and OH&S systems framework we commit ourselves to the following:

• Protection of environment including the prevention of pollution.
• Ensuring all employees, contractors and visitors have a significant level of training or awareness toward QMS, EMS and OH&S systems.
• Prevent injury, ill health and continual improvement in QMS, EMS and OH&S performance.
• Developing and maintaining a strong and positive QMS, EMS and OH&S culture in which all individuals are aware of product requirements and hazards of their working activities by implementation of standard operating procedures.
• Consultation and participation of workers at all levels and functions to development, planning, implementation, performance evaluation and actions for improvement of the OH&S management system.
• Communicating, Consulting, reporting performance and responding openly to our customers, employees, public interests group and those who work for us including all our stakeholders.
• Working with others including our partners, suppliers, competitors, and regulators to improve the standard of our products to reach satisfaction and when possible exceed our customers’ expectations.
• Complying with legal, regulatory requirements and other requirements related to QMS, EMS and OH&S systems.

By reviewing our QMS, EMS and OH&S Policies periodically and implementing them along with providing them to all interested parties, we aim to increase the level of confidence in our ability to offer safe and high-quality products.