Qualification Standard

Authorising body: Ministry of Industry and Trade
Group of fields: Engineering Chemistry and Chemistry of Silicates
Occupation:
Validity of standard: from 14/10/2015
Qualification level: 4

Qualification Standard

Vocational competence Level

Knowledge and comprehension of the principles of good manufacturing practice and pharmaceutical quality systems

4

Implementation of continuous monitoring of process controls in the pharmaceutical production

4

Compliance with the principles of working with active drug substances

4

Keeping hygiene regulations in the pharmaceutical production

4

Aseptic work and sterilization in the manufacture of sterile medicinal products

4

Production of non-sterile medicinal products

4

Clean room definitions in the chemical and pharmaceutical production

4

Preparation of pharmaceutically pure water

4

Working with a rule-making record documentation

4

Management of pharmaceutical processes, production equipment, qualification and calibration

4

Following entities have contributed

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

IMA EST

Masarykova střední škola chemická