Chemical and pharmaceutical manufacturing metrology support
About the Academic Course
The main goal of the course is to obtain theoretical and practical knowledge, skills and abilities in the field of metrological provision of chemical and pharmaceutical manufactures.The course is intended for 1st year students of the basic educational program for the preparation of masters "Analysis and control in chemical and pharmaceutical manufactures" direction of training 04.18.01 Chemical technology.
The course covers the following issues: legal and metrological support of enterprises, organizations and testing laboratories; metrological support of measuring instruments, test equipment and reference materials; certification and validation of processes and equipment; metrological requirements for measurement procedures (methods); certification, validation and verification of measurement procedures; measurement results and accuracy indicators; organization of internal quality control of test and measurement results; requirements for the competence of laboratories.
Particular attention is paid to the assessment of the quality indicators of methods and analysis results, the characteristics of the error of the measurement results, the operational quality control of the analysis results.
Learning outcomes
1. Apply knowledge of legislative and regulatory legal acts, national and international standards for metrological support of chemical and pharmaceutical enterprises (laws, GOST, GOST R, GMP, GLP, ISO).
2. Choose equipment, measuring instruments, standard samples and measurement (test) procedures for chemical and pharmaceutical products; organize verification and calibration of measuring instruments, certification of test equipment and standard samples; ensure laboratory competence.
3. Validate, verify and apply measurement and test procedures.
4. Calculate the metrological characteristics of methods and test procedures for chemical and pharmaceutical products; own methods of presenting measurement results in statistical quality control of products of chemical and pharmaceutical industries
2. Choose equipment, measuring instruments, standard samples and measurement (test) procedures for chemical and pharmaceutical products; organize verification and calibration of measuring instruments, certification of test equipment and standard samples; ensure laboratory competence.
3. Validate, verify and apply measurement and test procedures.
4. Calculate the metrological characteristics of methods and test procedures for chemical and pharmaceutical products; own methods of presenting measurement results in statistical quality control of products of chemical and pharmaceutical industries
Educational program track
18.03.01 Chemical technology
Academic course program
The course contains 4 main parts:
1. Questions of legal and metrological support
2. Metrological support
3. Measurement techniques
4. Quality control of measurement results and competence of laboratories
1. Questions of legal and metrological support
2. Metrological support
3. Measurement techniques
4. Quality control of measurement results and competence of laboratories
Course duration, quantitative characteristics, form of certification
Course duration - 18 weeks
The complexity of mastering the course - 108 hours, of which classroom work - 32 hours, self-guided work - 76 hours.
The complexity of the course is 3 credits, the form of control is an exam.
The complexity of mastering the course - 108 hours, of which classroom work - 32 hours, self-guided work - 76 hours.
The complexity of the course is 3 credits, the form of control is an exam.
Authors of the Course
Pikula Nina Pavlovna, Ph.D. Sci., Associate Professor of the Division for Chemical Engineering of School of Earth Sciences and Engineering TPU
https://portal.tpu.ru/SHARED/p/PIKULA
https://portal.tpu.ru/SHARED/p/PIKULA
Derina Ksenia Vladimirovna, Ph.D. Sci., Associate Professor of Associate Professor of the Division for Chemical Engineering of School of Earth Sciences and Engineering TPU
https://portal.tpu.ru/SHARED/d/DERINAKV
https://portal.tpu.ru/SHARED/d/DERINAKV
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