Qualification Standard

Autorizující orgán: Ministry of Industry and Trade
Skupina oborů: Engineering Chemistry and Chemistry of Silicates
Povolání: Chemical-pharmaceutical supervisor
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

Performance of continuous production monitoring 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 during production of sterile medicinal products

4

Production of non-sterile medicinal products

4

Work with regulatory and record keeping documentation

5

Knowledge and comprehension of the basics of logistics during chemical-pharmaceutical production

4

Performance of product protection during the production process

4

Expedited problem solving of organizational and operating problems in the department of which responsibility is assumed during the 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:

Masarykova střední škola chemická, Praha

Zentiva, k. s., Praha

Ferring-Léčiva, a. s., Jesenice