How Are Medicines Produced? International Standards
Raw materials in the form of powder go to an intermediate warehouse, where they are sorted, crushed, sifted, weighed, packed in special containers. Then the prepared material is sent to the production department. The entire technological process is documented, the amount of suspended medicinal substance, performers, production conditions are recorded in the production protocols for each drug. The transparency of the documentation allows you to trace the entire manufacturing process of each drug.
The next process is dry or wet granulation of the substance. The pellet must acquire a certain weight. The finished granulate is placed in a container, which is marked with a label with the name of the drug, the name of the granulator, date of manufacture, weight, and then fed to tableting.
Further production of tablets is associated with direct compression. This process consists of the steps of dosing, pressing, ejecting the tablet from the matrix and dropping it into the tablet receiving container. During the pressing process, the technologist has to check from time to time the average tablet weight and disintegration, its color and appearance.
After the tabletting process, drugs are obtained that are almost ready for use. It remains to carry out the last examination in the chemical laboratory for the quality of the product, for its compliance with the accepted pharmaceutical standards. When laboratory tests are positive, drugs are packaged.
Getting into pharmacy chains and online drug store, a pharmaceutical product brings significant income to businessmen. Still, the main thing in this business is caring for human health and a responsible attitude to the quality of medicines.
Medicines, as you know, do not immediately reach the consumer, but only after passing a certain, sometimes long and difficult path. The interests of the consumer need to be protected, which is why regulatory authorities in many countries take early steps to ensure the quality of medicines. These are, first of all, clinical trials, which are designed to provide adequate performance. And as a rule, this is the longest, most costly, crucial stage of drug development.
The development of high-quality drugs is a type of business that requires a rather tangible investment in time and money. All spent pays off and this is expressed not only in the form of profit, but also in the preservation of the health of people using the products of this business.
Many European countries, as well as the United States, developed a set of high requirements that began to be imposed on clinical trials of drugs prior to registration. This complex has been used since the late 70s of the XX century. These trials are called good clinical practice.
A unified approach to clinical trials is an important step by the world community in the field of drug registration and requirements for them. There is the International Conference on Harmonization (ICN), formed in the 90s.
The basis for the adoption of a regulatory framework for the licensing of medicines is the process of harmonization of registration requirements expressed in the ICN program.
It was possible to develop unified approaches, since technical obstacles in the international sphere of drug circulation were eliminated, in the form of mutual recognition of standards and the application of legislative acts for the production and sale of drugs. This applied to all questions on research, registration, form and structure of documents issued after registration.
In order for a drug to enter the market, many countries require a registration dossier for the drug. The difficulty in evaluating and recognizing the results of clinical trials was due to the variety of principles for conducting pre-registration trials in different countries.
In order to register a drug in another country (in the case of obtaining a trade license), it was necessary to conduct repeated clinical trials. This increased the cost of the medicine. In addition, to organize a clinical trial, specialists of different profiles are needed – carriers of special knowledge.
Based on the stage of development of a medicinal product, as well as on the task of testing, clinical pharmacologists and bio statisticians are involved in them. The drugs hit the market after a long period of time, depriving it of the timeliness and effectiveness of use.