The Organization is committed and focused in consistently provide:
- Products that meets customer and regulatory requirements
- Products safe and appropriate for their use.
The operational guideline of ELPEN Pharmaceuticals Co.Inc is to enhance customer satisfaction through the effective application of a quality system, including processes for continual improvement and the assurance of conformity to customer and applicable regulatory requirements in all levels (quality, service, communication with customers). In order to achieve this goal all the activities of the Organization should be properly designed and controlled.
Top Management recognize the need of the development and implementation of a Quality System and continually improving its effectiveness. This system should be in conformity with ISO 9001:2015 and also to the applicable regulatory requirements of Good Manufacturing Practices, Good Laboratory Practices, Good Storage and Distribution Practices.
In order to achieve those quality objectives the Organization keep abreast of customer's needs, developments in the international market of pharmaceutical products, OTC and medical devices and also of the current regulatory requirements.
The established Quality Objectives are as follows:
- No recalled batches.
- No rejected batches.
- Continues improvement of customer satisfaction.
- Production storage and distribution of pharmaceutical products according to applicable regulatory requirements.
- Storage and distribution of Medical Devices and OTC's according to applicable regulatory requirements.
- Minimization of the percentage of ''non conformities'' during production and Quality Control of Pharmaceutical products.
- Minimization of customers’ complaints and improvement of the communication with them.
- Increase of productivity.
The Quality Objectives are measurable through Quality Factors and consistent with quality policy.
Top Management has appoint a member of the Organization that, irrespective of other responsibilities, is responsible and authorized to:
- Ensure that processes needed for the Quality Management System are established, implemented and maintained.
- Report to Top Management on the performance of the Quality System and any needs for improvement.
- Ensure the promotion of awareness of customer and regulatory requirements through the Organization.
Top Management is committed to provide all relevant resources for the development, implementation and maintenance and continuous improvement of an effective Quality Management System in conformity with ISO 9001:2015 and the applicable Greek and EU regulatory requirements related to the activities of the organization including but not limited to Good Manufacturing Practices, Good Laboratory Practices, Good Storage and Distribution Practices, Good Clinical Practice and Good Pharmacovigilance Practice.
The framework of this Quality Policy has three main keystones:
- Implementation and maintenance of an effective Quality Management System
- Customer satisfaction
- Continuous improvement
Those are the duty and contribution of ELPEN Pharmaceuticals Co.Inc employees.