Nobel Almaty Pharmaceutical Factory JSC is one of the largest Kazakhstan pharmaceutical companies. It is actively developing in terms of exporting products and is a contract manufacturing site of well-known transnational pharmaceutical companies. The company specializes mainly in the manufacture of drug products in the form of tablets and capsules. The range of products is more than 280 types of drug products. This is a wide range of products for the treatment of both widespread and rare diseases, as well as malignant neoplasms. All available manufacturing sites are GMP certified. Recently, a new workshop was commissioned at the enterprise. We asked to tell Ms. Z. A. Abdraimova, candidate of pharmaceutical sciences, authorized person, head of the quality assurance department of the Nobel Almaty Pharmaceutical Factory JSC.
- Zhanat Abilovna, please tell us more about the new workshop? What products will be produced in it?
- In the new workshop, which has recently been successfully inspected by the Ministry of Health of the Republic of Kazakhstan for compliance with the GMP standard, the products of general therapeutic groups will be produced. In principle, the range of products will be the same as in the current workshop No.1. These are painkillers and anti-inflammatory drugs, drugs for the treatment of allergies, sleep disorders, diseases of the gastrointestinal tract, cardiovascular system and others. But still, this new production site has a number of features, since its design and construction was carried out taking into account accumulated experience and new knowledge. New production was launched, based on the company's plans to increase volumes and expand the range of products.
Talking about the technological innovations of this workshop can be a long time. I will focus only on some of them. There are modern production lines from globally recognized manufacturers have installed in the workshop. They are equipped with measuring instruments to control quality and withstand the optimal parameters of technological processes.
All technological processes are automated as far as possible. They are controlled remotely by touch screens that are located in production halls (corridors). This reduces the risk of cross-contamination, minimizing the presence of personnel in production facilities. In addition, special modern automatic CIP-stations (Cleaning In Place) have been installed, which produce high-quality cleaning of technological equipment, both inside and outside. Production processes are controlled by special programs, which ensures traceability of all stages of the manufacture of the product and allows you to get a product whose quality remains unchanged from series to series (batches).
In general, everything has been done in order to increase productivity and ensure high quality of the finished product, and, ultimately, also reduce its cost.
- At present, the unified pharmaceutical market of the EAEU countries has already been launched. Tell me, when organizing production, are you more focused on the Kazakhstan GMP standard, or on the EAEU requirements?
- In general, the national standard of Good Manufacturing Practice and the EAEU’s GMP Guidelines, in fact, represent the GMP of the European Union. Of course, we strictly adhere to the provisions established in these documents. But these standards contain only recommendations, i.e. talking about how it should be, they may lack specific technical requirements and clear formulas. Therefore, when there is a need for precise instructions, we focus on the requirements established in the GMP standards of other countries, which are recognized leaders in the field of regulation of drug circulation and pharmaceutical production, for example, the USA.
- Zhanat Abilovna, you have included the register of authorized persons of the EAEU countries on behalf of the Nobel AFF company. Such an official has recently appeared at pharmaceutical enterprises in Kazakhstan. Please, tell us about its role and functions.
- In essence, the authorized person has one function - issuing permission to sell a batch of products. But the basis for execution should be a firm belief that the batches of the product was produced properly, in accordance with the established GMP requirements, and that the product meets the specified quality parameters. In order to have such confidence, the authorized person must be aware of all changes or deviations in the production (manufacturing) process, starting from raw materials, excipients and packaging materials, and ending with the finished product.
An authorized person reports directly to the CEO and is independent in making decisions. Its decisions regarding the product are final and cannot be changed or canceled by other managers and by the general director. This is what ensures fairness and objectivity in decision making. The consumer must receive a quality product, the therapy efficacy and, ultimately, the disease outcome and his/her health depend on it. Therefore, an authorized person bears a great moral and legal responsibility. Moreover, it is always in the area of high risk of conflicts with the top management of the enterprise. After all, stopping or removing a product from production at an intermediate stage is always a loss. But quality should always be a priority, because launching a low-quality product on the market can result in even greater negative consequences for owners and managers of the enterprise.
Much depends on the level of responsibility and qualifications of the authorized person. It oversees the production processes and quality control of the product. In order to assess risks and understand what this or that situation may lead to, one needs to have in-depth knowledge in different scientific fields. Therefore, an authorized person is a “piece-goods”.
- In your opinion, what requirements should be imposed on an authorized person?
- A highly qualified specialist (expert) with knowledge of national and international legislation, a deep understanding of GMP / GDP, the technologies used and control methods should be involved in the position of an authorized person. The authorized person must be subject to exactly the same requirements as the pharmaceutical production inspector, because his/her level should not be lower. In fact, the authorized person is the “eyes and ears” of the regulatory body, the state inspecting body. It is the decision of the authorized person to issue the batches that serves as a guarantee for the quality of products for the regulatory body. It is through an authorized person that the regulatory body receives the necessary information on compliance with the GMP principles of commitment undertaken by the manufacturer when registering the product.
An authorized person is a person who represents the interests of the population and the state in a particular pharmaceutical enterprise. Actually, he carries out a GMP inspection of the production process of each batches for compliance with the analytical regulatory document, internal specifications and other documents. That is why the Ministry of Health should be interested in authorized persons and work together with them properly.
Three (3) truths that an authorized person should be guided by:
- quality creates a reputation of the company and, as a result, ensures economic stability,
- incompetence can cost a company a lot,
- An efficient and well-functioning quality management system is the key to successful inspections and audits results.
- Thanks for the interview.