Answer:To ensure the safety, efficacy and controllable quality of drugs, and to ensure the safety and efficacy of people's medication.
2What are the main contents and steps of drug testing?
Answer: The main content: (1) the test of raw materials (2) the test of pharmaceutical preparations (3) the test of traditional Chinese medicine preparations (4) the test of biochemical drugs (from the Introduction to Pharmacy, China Medical Science and Technology Press 2005)
Steps: (1) sampling (2) identification (3) inspection (4) content determination (5) write a laboratory report
(From the Drugs Analysis" Human Health Sixth Edition)
3 What is the regulatory basis for drug testing?
Answer Chinese Pharmacopoeia, 2005 edition
4 Modern biopharmaceutical technology includes those technical systems? What is the relationship between them?
Answer: Technical systems: (1) genetic engineering (2) enzyme engineering (3) cellular engineering (4) fermentation engineering
Relationship: all use the metabolic reactions of biological cells (or microbial transformation reactions) to synthesize drugs or drug intermediates that are difficult to synthesize chemically (Biochemistry of Human Health, Sixth Edition)
Supplemental Answers
1 Briefly describe the comprehensive Quality Management (QM) 2 What is GMP and GMP certification, and what are the main components of GMP certification? 3 Is it not necessary to study chemistry as opposed to natural biopharmaceuticals or chemical drugs? 4 What is (bio)pharmaceutical technology, biopharmaceuticals, and biotechnology drugs? 5 What is the basic process of modern biotechnology pharmaceuticals?
1 Briefly describe the basic idea of total quality management
In order to control the quality of drugs comprehensively, quality control of drugs and preparations in the production process should be carried out, the quality of intermediates should be strictly controlled and the main processes affecting the quality of the drugs should be found, so as to optimize the conditions of the production process in order to promote production and improve the quality of the products, and close collaboration with the operation and management departments should be strengthened as well, paying attention to the It should also strengthen close collaboration with the management department, pay attention to the stability of the drug in the storage process, and adopt scientific and reasonable storage conditions and management methods in order to ensure the quality of the drug. In clinical application, it is crucial to carry out monitoring of therapeutic drugs, which is conducive to the reduction of drug toxicity and side effects, and to improve the quality of the use of drugs.
The implementation of the four scientific management norms of GLP GMP GCP GSP strengthens the overall quality control of medicines, which is conducive to the development of China's pharmaceutical industry and improves international competitiveness.
2What is GMP and GMP certification?The main contents of GMP certification include those?
GMP is the abbreviation of Good Manufacturing Practice, which means "Good Manufacturing Practice" in Chinese, and is the basic guideline for pharmaceutical production and quality management. It applies to the whole process of pharmaceutical preparation production, the key processes that affect the quality of finished products in the production of APIs. The State Food and Drug Administration is responsible for the national drug GMP certification, through the GMP certification that is to achieve the standards set by the GMP. GMP includes raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control and other aspects of the relevant national regulations to meet the health and quality requirements, to form a set of operational practices.
3 As opposed to natural biological drugs chemical drugs There is no need to learn chemistry?
Your question I did not read, if you ask me whether there is a need, of course, there is
4 What is (bio-)pharmaceutical technology, biopharmaceuticals, and biotechnology drugs?
Biopharmaceutical technology: also known as bioengineering, is a system that uses biological organisms (animals, plants, microorganisms) or their components (including organs, tissues, cells or organelles, etc.) to develop new products or technologies
Biopharmaceuticals: the use of living organisms, biological tissues, or their components, and the integrated application of the principles and methods of biology, biochemistry, microbiology, immunology, physicochemistry And pharmacology and other principles and methods of manufacture of a large class of products for the prevention of diagnosis and treatment.
Biotechnology drugs: the use of recombinant DNA technology and monoclonal antibody technology to produce peptides, proteins and enzymes, as well as vaccines, monoclonal antibodies, cell growth factor drugs and soluble receptors
(Biochemistry, Human Health, Sixth Edition)
5 modern biotechnology, pharmaceuticals, the basic process of how?
Answer: (1) Acquisition of target genes (2) Selection and construction of gene vectors (3) Splicing of target genes and vectors (4) Introduction of recombinant DNA into recipient cells (5) Screening and asexual propagation of recipient cells (transformants) containing recombinant molecules (6) Mass cultivation of engineered bacteria (or cells) and production of target proteins