Qualification Standard

Authorising body: Ministry of Industry and Trade
Group of fields: Engineering Chemistry and Chemistry of Silicates
Occupation: Pharmaceutical chemical operator
Validity of standard: From 15/1/2021
Qualification level: 4

Qualification Standard

Vocational competence Level

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

4

Management of pharmaceutical processes, production equipment, qualification and calibration

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

Working with a rule-making record documentation

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:

Masarykova střední škola chemická, Praha

Zentiva, k. s., Praha

Ferring-Léčiva, a. s., Jesenice