Quality / Certificates

• 
• »
• About Company
• »
• Quality / Certificat...

Quality Policy in Chemistry and Pharmacy Cooperative ESPEFA

The main activity of Chemistry and Pharmacy Cooperative (ESPEFA) is the production and sale of medical products with particular care for their quality, effectiveness and safety requirements.

The manufactured products measure up to both physician and patient's expectations as regards therapeutic effects and quality. For this purpose the producer has worked out and put into practice the quality policy which is fundamental for the firm and for maintaining the quality of our medical products.

We intend to achieve these objectives owing to our conformity with ISO standards and the compliance of a production process with GMP requirements, which is vital for ensuring the quality of our products; and due to the formulation and implementation of some other strategies/policies indispensable for the firm activity under current circumstances and in the existing market.

The area of greatest importance in our activity is a policy of growth and innovation. This policy is closely related to a strategy of personnel management and training, to a systematic cost reduction policy as well as to work and to production conditions realised in everyday practice.

Quality Management System in Chemistry and Pharmacy Cooperative ESPEFA

The Cooperative activity meets the requirements under the regulations of the Pharmaceutical Law of 6th September 2001, and is in conformity with ISO 9001: 2000 Standard.

ESPEFA is awarded the BSI Management Systems certificate to confirm that the Cooperative has implemented the Quality Management System in accordance with BS EN ISO 9001: 2000 Standard in the area of designing, development, manufacturing and distribution of medical products.

The main document of the Quality Management System is a Quality Book, in which the Cooperative Quality Policy has been formulated.

The Quality Management System by ISO 9001:2000 is under supervision and open for inspection by external as well as internal auditors.

The pharmaceutical inspectorate carries out the periodic inspections of production conditions.

Indoors Quality Control of the Cooperative is responsible for the examination of raw materials, half-finished products and final products. Every batch of a raw material or a product is subject to laboratory analyses.

ISO