Documentation of Pharmaceutical Development. Part 2. Quality System Documents

Introduction. In the process of pharmaceutical development of a medicinal product, it is necessary to substantiate the composition of the medicinal product; develop a technology for a finished dosage form (including a primary packaging system); create documentation for various stages of product development; validate analytical methods and technological processes. Information obtained in the course of experimental research and development of a medicinal product is included in the registration dossier. Documenting a pharmaceutical development allows you to systematize knowledge about monitoring technological processes, product quality indicators, and present the integrity of the data obtained.
Aim. Creation of documentation for pharmaceutical development within the pharmaceutical quality system of the enterprise.
Materials and methods. In the course of the research, the following methods were used: content analysis; system analysis; systems approach.
Results and discussion. On the pharmaceutical development of two-component suppositories within the FGC, based on the knowledge gained about the process and the product and taking into account the risk analysis, we have created documents that were adapted to the enterprise's document flow to optimize the documentation process at the subsequent stages of the drug's life cycle. For optimal documentation of the first stage of drug development, a list of documents is proposed, including: Report on the pharmaceutical development of two-component suppositories; specifications for raw materials and materials, intermediate products, finished products; standard operating procedures during the pharmaceutical development phase; Guidelines for monitoring processes and product quality; Instructions for corrective and preventive actions (CAPA), change management, management review; report on the analysis of the effectiveness of the quality assurance system in the pharmaceutical development of two-component suppositories. The proposed set of documents makes it possible to form a single base of knowledge and results obtained at this stage, to systematize and structure them.
Conclusion. In the course of the pharmaceutical development of two-component suppositories, knowledge has been generated about the process of creating a product of proper quality. A set of documents has been developed, consisting of reports, specifications, standard operating procedures, instructions, for an enterprise planning to produce two-component suppositories. Pharmaceutical development documentation is adapted to the enterprise document flow to optimize the documenting process at the subsequent stages of the drug product life cycle.

1. Rozhnova S. A., Tsypkina A. V. Analysis of the system organization of pharmaceutical drug development. Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. 2017;3(20):170–176. (In Russ.)

2. Brkich G. E., Pyatigorskaya N. V., Beregovykh V. V., Zyryanov O. A., Demina N. B., Bakhrushina E. O. The development of the physicochemical characteristics of the new original nootropic substance TST-9. Biomeditsinskaya khimiya = Biomedical Chemistry. 2020;66(3):257–264. (In Russ.)

3. Gildeeva G. N., Belostockiy A. V. Kontseptsiya Quality-by-Design kak klyuchevoy element v obespechenii kachestva lekarstvennykh preparatov [Quality-by-Design concept as a key element in ensuring the quality of medicines]. Remedium. Zhurnal o rossiyskom rynke lekarstv i meditsinskoy tekhnike. 2017;3:54–57. (In Russ.)

4. ICH Q10 Pharmaceutical Quality System. Avaliable at: http://www.ich.org. Accessed: 22.03.2020.

5. Alexandrov A. V. The first GMP principle: continuous improvement of the pharmaceutical company’s quality system. VIALEK group of companies. Electronic resource. Avaliable at: http://www.vialek.ru/press/articles/653/ Accessed: 22.03.2020. (In Russ.)

6. Smekhova I. E., Shigarova L. V., Meteleva V. D., Flisyuk E. V. Documentation of Pharmaceutical Development. Part 1. Study of the Documentation of the Site. Razrabotka i registratsiya lekarstvennykh sredstv = Drug development & registration. 2021;10(1):142–147. (In Russ.)

7. Nikityuk V. G., Shakina T. N. Nadlezhashchaya dokumentatsiya farmatsevticheskoy kompanii – sistematizatsiya, strukturirovanie, upravlenie i otsenka. Chast' 1. Strukturirovanie i sistematizatsiya protsessov i sistemy nadlezhashchey dokumentatsii [Pharmaceutical company proper documentation – systematization, structuring, management and evaluation Part 1. Structuring and systematization of processes and a system of proper documentation]. Farmatsevticheskaya otrasl' = Pharmaceutical industry Review. 2016;2(55):78–83. (In Russ.)

8. Artamonova M. A., Golubinsky Yu. M. Razrabotka dokumentirovannoy protsedury sistemy menedzhmenta kachestva po upravleniyu dokumentatsiey. VII Mezhdunarodnaya studencheskaya nauchnaya konferentsiya Studencheskiy nauchnyy forum – 2015. [Development of a documented quality management system procedures for managing documents]. February 15 to March 31, 2015. Avaliable at: https://scienceforum.ru/2015/article/2015013197. Accessed: 22.03.2020. (In Russ.)

9. Pyatigorskaya N. V., Beregovykh V. V., Aladysheva Zh. I., Be lyaev V. V., Meshkovskii A. P., Pyatigorskii A. M. Automated document management system of pharmaceutical manufacturer’s quality management system in accordance with requirements of GMP. Vestnik Rossiiskoi akademii medetsinskikh nauk = Annals of the Russian Academy of Medical Sciences. 2017;72(2):126–133. (In Russ.)

10. Kryuchkov D. V., Batsina E. A., Danil’chenko Ia.V., Karas’ D. V., Artamonova G. V. The experience of transition to risk-oriented model of system of quality management in medical organization. Zdravookhranenie Rossiiskoi Federatsii = Health Care of the Russian Federation. 2017;61(6):309–315. (In Russ.) DOI: 10.18821/0044-197Х-2017-61-6-309-315.

11. ICHQ8 Pharmaceutical development. Avaliable at: http://www.ich.org.

12. Bykovskiy S. N., Vasilenko I. A., Demina N. B., Shokhin I. E., Novozhilov O. V., Meshkovskiy A. P., Spitskiy O. R. Farmatsevticheskaya razrabotka: kontseptsiya i prakticheskie rekomendatsii [Pharmaceutical Development: Concept and Practical Guidelines]. Moscow: Pero; 2015. 526 p. (In Russ.)