The implemented standards stand on the requirements which have to be followed in order to fulfill regulatory demands and expectations of clients.

This involves the European guidelines of Good Manufacturing Practice (EU GMP) and standard EN ISO 9001 as well as other standards in accordance with ZADA Pharmaceuticals Rules of Procedure for the Quality.

The Quality sector of ZADA Pharmaceuticals is responsible for the maintenance of the quality system.

The Quality sector includes:

• Sector for Quality Assurance
• Sector for Quality Control
• Sector for Registration

ZADA Pharmaceuticals develops products whose quality satisfies the needs of clients. High-quality is our long-term responsibility together with adherence to the high adopted standards in all aspects of our professional circles. Every employee actively participates in quality development, and accordingly to the valid documents of quality assurance in the scope of his/her duties in order to ensure the high work quality.

The basic element of maintenance of ZADA Pharmaceuticals quality system is the Rules of Procedure for Quality. Except for its role to describe the system itself, this document also defines the aim of quality; it is based on GMP elements that are relevant for ensuring the high-quality of pharmaceutical products.

The quality assurance system in the production of pharmaceutical products in ZADA Pharmaceuticals is defined accordingly to the following principles:

• Active Pharmaceutical Ingredients (API) and products are designed and developed in accordance with the market inquiries and GMP;
• Defined procedures in the production process and control are aligned with GMP;
• Responsibilities are clearly defined on all levels;
• All necessary analyses of raw and packaging materials, intermediate goods and finished products are conducted;
• Validated critical steps in production and control are standardized;
• Products are developed in accordance with approved technical procedures and they are tested correspondingly to the defined and validated quality control procedures;
• Release of products on the market is approved only after QP confirms compliance with GMP and regulatory inquiries, and also after it confirms compliance of analysis results with the specification of the finished product;
• Precautionary measures of storage and transport (temperature, humidity, light) are clearly defined, and they assure the quality of the product until the expiration date;
• The procedure of internal audit used for efficiency evaluation and implementation of quality assurance is regularly conducted;
• The system of quality assurance is regularly maintained and improved.

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Quality control

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Quality assurance

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