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GMP in Russian realities. Open conversation with the quality director

Interview with Olga Maklakova, winner of the IV All-Russian GMP Conference "Best Quality Director-2019" among the largest pharmaceutical companies, Quality Director of AKRIKHIN JSC.

In 2014, when the requirements of the Russian GMP standard were introduced, many experts expressed skepticism about the possibility of introducing good manufacturing practices at national pharmaceutical enterprises in a timely manner. Nevertheless, the quality management system of Russian manufacturers has demonstrated its flexibility and viability. This was reflected in the results of license control, which is demonstrated by indicators of compliance with standards. Among the national champion companies, the leading Russian pharmaceutical company AKRIKHIN JSC holds an honorable place. Olga Maklakova, a recognized expert, winner of the IV All-Russian GMP Conference "Best Quality Director-2019" among the largest pharmaceutical companies, director by the quality of JSC "AKRIKHIN".

Interviewed by: Yulia Mushtakova, science journalist, editor-in-chief of the Teledoktor project of the Doctor TV channel (VGTRK), host of the All-Russian Pharmaceutical Run-2020.

Olga Valentinovna, GMP is often perceived as a formality in Russian realities. What, in your opinion, is GMP, what is fundamental in this concept?

I would not like to answer this question in a formulaic way, giving a standard definition. I believe that GMP is perceived as a formality only by those people who underestimate all the consequences of non-compliance with these standards. Recall that good manufacturing practices were developed with the key goal of protecting the patient and ensuring the quality, efficacy, and safety of a drug throughout its manufacturing cycle. Accordingly, if someone perceives the patient's health as a formality, then he was mistaken with the profession. GMP standards for pharmaceutical manufacturers are like the Hippocratic oath for doctors, our code of honor and conscience.

Any production used to be based on GOST. What is their fundamental difference from GMP requirements?

GOST is a state standard that formulates the state's requirements for the quality of products, works or services that are of inter-industry importance. Compliance with them is mandatory if the contractor has publicly declared the compliance of his products with GOST and applied this in the labeling or his documentation. In other options, compliance with these requirements is voluntary. The situation with GMP is quite different. These rules are binding in full in all cases, and they are directed only to the pharmaceutical industry.

GMP rules define the approach without describing the specifics of execution. Therefore, each manufacturer independently builds its own pharmaceutical quality system and proves the correctness of its implementation of each GMP item on the basis of its own documents: standard operating procedures, records of each production step and product quality control, organized quality system processes.

You yourself mentioned that GMP standards were introduced only in 2014. What came before? As a GMP expert, what did you have to learn new in your profession?

Before the introduction of GMP rules, several standards existed and were used: ISO 9000, RDI, OST, GOST, translations of international "Orange Books". However, the entry into force of the document of 2014 put the final point in manufacturers' doubts about whether or not I will introduce GMP rules. Nowadays, everyone understands that this standard is mandatory.

I would not speak about myself in the past tense, I am still open to everything new. GMP rules are a living organism, they are called cGMP for a reason, which means the current version - they develop, new directions appear, such as data integrity, toxicological approach, continuous verification. In the near future, for example, the EAEU GMP Rules will start in the Russian Federation, and this is again a new challenge, since they represent a whole set of documents that must be introduced and followed.

How to convey the need to comply with these requirements to all participants in the production process, from first-level personnel to top managers, so that GMP does not remain at the level of a formal approach, but becomes a production philosophy?

Leaders - GMP managers - themselves should be a role model, demonstrate to employees by personal example that compliance with the rules is an integral part of their professional activities. In addition, clear procedures and training of personnel are very important, it is necessary that they be competently developed and applied in practice. It is impossible to implement the GMP philosophy at an enterprise in one day or even a year. These are years and years of painstaking and dedicated work of the organization as an integral structure, of all its employees, for the benefit of society and patients. It is imperative to talk with the staff - laboratory staff, production operators, engineers - to explain the importance of these standards every day.

In addition, GMP compliance is maintained at the state level. If an unscrupulous manufacturer does not fulfill any of the requirements, then there is a high risk that he produces drugs that threaten the life and health of the patient. Such drugs should be banned from production, and these are already risks for business.

Please share an example from your experience of how the introduction of one or several components of GMP helped to change the situation in production for the better?

Personnel is one of the key factors in the implementation of GMP. His “pharmaceutical” mentality is very important. In our production, regardless of whether it is an audit or a regular daily work, order is always maintained. For example, route maps are filled out neatly, as if there was an inspector behind. It is difficult to tell in a nutshell how it was implemented, but it is undoubtedly the merit of senior management and production managers and the result of constant, thorough and systematic work.

Another example is the widespread introduction of computerized systems. Three years ago, we began statistical processing of critical production and quality parameters, which significantly and several times increased our confidence in the quality of our products.

Another point is data integrity, implementation of a time source and time synchronization. This is a simple example, but it allows us to trust our data. They simply cannot be counterfeited, which is very important for the pharmaceutical industry.

We work with the staff every day. We have created an error classifier that helps employees determine if there is an error. People understand that, for example, prescriptions must be filled out correctly, sloppiness is unacceptable. This is the pharmaceutical mentality. We conduct a careful selection of personnel, HR strives to ensure that only employees who are able to work with such requirements come to us. The new employee undergoes three months of training with a mentor. Then he is allowed to work independently. In the process of training and passing the exam, we understand whether this is our person, whether he is suitable for the pharmaceutical industry or not. It is important that he understands this himself.

Olga Valentinovna, you are the winner of the "Best Quality Director" award, an award that was presented to you by the State Institute of Medicines and Good Practices. How did you feel when you received such an award?

I felt that this was my finest hour. This is a recognition of my work over the decades. To bring such a prize to your company, recognition that you are one of the best is an honor for me. I believe that this is not only my merit, but also the whole company, all my colleagues.

We congratulate you on this award, we believe that this is not the last award that you and the company as a whole have been awarded. Thanks!

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