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- Technology Pharmaceutical Production
Technology Pharmaceutical Production
QUALIFICATION
- First Stage of Higher Education - Bachelor of Technics and Technologies
MODEL OF GRADUATING STUDENT
Upon completion of this program, it is expected that undergraduates will be able to
LO1. Possess theoretical knowledge and practical skills for developing the technology for the production of medicines and medical devices.
LO2. Differentiate drugs in various dosage forms, organize the technology of their production, as well as substances and excipients in accordance with the requirements of Good Pharmacy and Manufacturing Practices (GPP, GMP) and SP RK.
LO3. Manage the technological processes of manufacturing drugs in the form of substances, excipients and preparations in pharmacy conditions, pilot industrial and industrial series, determine the stability of drugs in the selected storage mode and packaging, the conditions for their transportation and sale in accordance with the current legislation of the Republic of Kazakhstan in the field of healthcare, GPP, GMP and Good Distribution Practice (GDP).
LO4. Carry out the calculation and selection of equipment, production lines, installations, calculations of the optimal quantities of loaded components for the formation of pilot industrial and industrial series, taking into account the minimum and maximum working volumes of technological equipment, step-by-step and final validation control of the manufacturing process of drugs and medical devices.
LO5. Determine, in accordance with international standards and internal documents of the quality and management system, the quality indicators of drugs, their substances, excipients, medical devices and develop regulatory documents /certification for them in accordance with the requirements of the SP RK and GMP.
LO6. Qualify hardware equipment, validate production technologies for drugs and medical devices, analytical methods for controlling their quality, develop and compile validation reports.
LO7. Identify the active and auxiliary substances of drugs using modern physicochemical methods, make up medical devices for providing input and output control of technological processes for the production of drugs and medical devices.
LO8. Apply advanced innovations in the production technology of drugs and medical devices, while monitoring their quality and standardization indicators, assessing the compatibility and ratio of substances and excipients in medicines.
LO9. Develop pharmaceutical development and regulatory documentation for drugs and medical devices in the form of technological instructions for their production, interim analytical normative documentation, packaging and labeling projects, reports on their stability to confirm the shelf life and storage, validation, medical use, implementation and transportation instructions in accordance with the requirements GMP and SP RK.
LO10. Apply normative legal acts and standards for the production of effective and safe medicines for the human body, their state registration, implementation and pharmacological supervision.
LO11. Search, select and analyze information obtained from various sources in order to optimal solution, in accordance with the requirements of the State regulations, professional tasks related to the production, quality control, packaging, storage, transportation and sale of drugs and medical devices.
LO12. Analyze and inform the audience with professional and unprofessional training on procedures related to safety, pharmacological effectiveness, storage and sale of medicines in accordance with the requirements of Good pharmacy, production, distribution practices, good pharmacovigilance practices (GPP, GMP, GDP, GVP) and SP RK
Program passport
disciplines
Data for 2022-2025 years
disciplines
Data for 2022-2025 years
INTERNSHIPS
Data for 2022-2025 years