Qualification Standard

Autorizující orgán: Ministry of Industry and Trade
Skupina oborů: Engineering Chemistry and Chemistry of Silicates
Povolání:
Platnost standardu: From 10/4/2018
Kvalifikační úroveň: 4

Kvalifikační standard

Název odborné způsobilosti Úroveň

Knowledge of principles of good manufacturing practices and pharmaceutical quality systems

5

Chemical-pharmaceutical process management

5

Assurance of qualifications, validations, calibrations and monitoring of devices during chemical-pharmaceutical production

5

Performance of continuous production checks during pharmaceutical production

4

Compliance with principles of work with active medicinal substances

4

Compliance with hygienic principles during pharmaceutical production

4

Aseptic work and sterilization in production of sterile medicinal products

4

Production of non-sterile medicinal products

4

Preparation of purified water for pharmaceutical use

5

Work with regulatory and record keeping documentation

5

Check of air-conditioning systems and clean premises during chemical-pharmaceutical production

4

Na tvorbě standardu se podíleli

The qualification standard was prepared by the Sector Council for chemical industry. It has been established and licensed for this activity by the Chamber of Commerce of the Czech Republic and the Confederation of Industry of the Czech Republic.

 

Entities represented in the following work group have contributed:

Zentiva

Ferring-Léčiva

Masarykova střední škola chemická