| 5 . Contents of the topic:
1 . The subject and content of pharmaceutical chemistry, its relationship with chemical, medical, biological and pharmaceutical disciplines.
2 . General provisions on the organization of quality control of medicinal products in Ukraine.
3 . State Pharmacopoeia of Ukraine, International Pharmacopoeia, and other ICAs regulating the quality of pharmaceuticals.
4 . Classification of medicinal products.
5 . Inorganic halogen group drugs : preparation, properties (description and solubility), identification, purity test, quantification,
The pharmaceutical industry in the European Community meets the standards of high quality requirements for the development, manufacture and control of medicinal products. Since it is impossible to control every single unit of a medicinal product, it is of particular importance to ensure and confirm the quality of the drug production process. One of the fundamental elements of quality assurance in the manufacturing process is the compilation of Good Manufacturing Practices (GMP) for medicines.
The GMP rules are designed primarily to reduce the risk inherent in any pharmaceutical product that cannot be completely avoided by testing finished products.
The EU pharmaceutical industry operates in accordance with standards that have high requirements for quality assurance in the development, production and control of drugs. The system of granting trade licenses requires that all medicinal products undergo examination by a competent authority to ensure that they meet current requirements for safety, quality and effectiveness. The Production Licensing System ensures that all products authorized for sale in the European market are manufactured only by manufacturers with the appropriate license.
In 1991, the Commission adopted two directives laying down the principles and rules of the LWP SP; the first directive relates to human medicines, the second to veterinary SPhU.
The requirements of CWP apply to the production of finished drugs for humans, including:
their complete and incomplete production,
different processes of packaging, packaging and marking,
as well as all medicines that are commercially available, including those that are manufactured in small-scale in pharmacy settings and medicines for clinical trials.
The manufacturing license holder is obliged to manufacture the drugs in such a way as to ensure their compliance with their purpose, the registration dossier and to exclude the risk to patients of insufficient safety, quality or efficacy of the drugs, together with the Authorized Person, he shall bear additional legal responsibility. All parts of the quality assurance system must be properly maintained:
· Competent staff,
· Adequate space,
· Appropriate equipment and technical facilities.
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