REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)

Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required.

Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post – registration period. The first post-registration changes in the regulatory documentation were administrative in nature and did not require examination of samples of the drug. The next group of changes in the documents of the registration dossier was due to the expansion of production, reconstruction of technological sites and the introduction of innovative technologies in order to comply with the requirements of GMP, as well as improving the consumer properties of the drug. The last group of changes concerned the revision of methods of quality control of finished products associated with the introduction of modern analytical equipment, expanding the list of standards and bringing into compliance with the requirements of the state Pharmacopoeia XIII edition.

Conclusion. The timely introduction of changes into documents of the registration dossier allows you to optimize the procedure for the conduct of internal and external control of rabies immunoglobulin, as well as to avoid violations related to the actualization of the technological documentation. The analysis of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blood serum liquid», solution for injections, reflecting the improvement of biotechnology of drug production and methods of its control in the post-registration period. Timely changes in the documents of the registration dossier allow to optimize the procedure of internal and external quality control of anti-rabies immunoglobulin, as well as to avoid violations associated with the updating of technological documentation.

1. Order of the Ministry of Industry and Trade of the Russian Federation dated July 14, 2013. № 916 «Rules for organizing the production and quality control of medicines» (In Russ.).

2. Murashko M. A. Current issues of ensuring the quality of medicines and medical devices in modern conditions. Pharmaceutical technology and packaging. 2014; 5: 80–86 (In Russ.).

3. Orlov V. A. Analysis of key trends in the results of inspections of foreign manufacturers of medicines for 2016. Drug development & registration. 2017; 2(19): 266–271 (In Russ.).

4. Order of the Ministry of Health of the Russian Federation of December 13, 2016 № 959n «Classification of changes made to documents contained in the registration dossier for a registered drug for medical use» (In Russ.).

5. Federal Law of 12 April 2010 № 61-ФЗ «On Circulation of Medicinal Products», with amendments and additions dated July 27, October 11, November 29, 2010, December 6, 2011, June 25, December 25, 2012. July 2, November 25, 2013, March 12, October 22, December 22, 2014, March 8, June 29, July 13, December 14, December 2015, June 2, July 3, 2016, 29 July 28, 2017, June 4, 2018 (In Russ.).

6. Abramova E. G., Nikiforov A. K., Lobovikova O. A. et al. Production of heterologous rabies immunoglobulin – results of the first five years. Problems of especially dangerous infections. 2010; 3(105): 58– 62. (In Russ.).

7. Onishchenko G. G., Popova A. Yu., Ezhlova E. B. et al. Epidemiological situation and issues of identification of the rabies virus among people in the territory of the Russian Federation in the period 2002–2015. Problems of especially dangerous infections. 2017; 3: 27–32 (In Russ.). DOI: 10.21055/0370-1069-2017-3-27-32.

8. Karpov S. N., Preger S. M., Sinel’nikov S. P. Fedorova Yu. V. Hyperimmune sera. Tomsk, 1976; 380 (In Russ.).

9. Selimov M. A. Rabies. M.: Medicine, 1978; 336 (In Russ.).

10. Federal Law of May 8, 2010 № 83-ФЗ «On Amendments to Certain Legislative Acts of the Russian Federation in Connection with Improving the Legal Position of State (Municipal) Institutions», with amendments and additions dated July 27, November 8, 2010, February 7, July 18, December 6, 2011, December 29, 2012, April 5, May 7, December 28, 2013, May 5, October 4, December 31, 2014, November 3, December 29, 2015 November 30, 2016, November 27, 2017 (In Russ.).

11. Pryahina E. A. Packaging of drugs: current issues of expertise // GMP news. 2018; 2(16): 106–111 (In Russ.).

12. State Pharmacopoeia of the Russian Federation. XIII ed. V. 1. MZ RF. M., 2015; 1470. (In Russ.).

13. Generalov S. V., Kireev M. N., Abramova E. G., Lobovikova O. A. Optimization of gas chromatography to control residual ethanol in the preparation of heterologous rabies immunoglobulin. Acta Biomedica Scientifica. 2012; 5-1(87): 197–200 (In Russ.).

14. State Pharmacopoeia of the Russian Federation. XII edition. Part 1. MZ RF. M., 2008; 704 (In Russ.).

15. Abramova E. G., Lobovikova O. A., Shul’gina I. V. et al. Development of a standard sample of an enterprise (SOP) of a specific anti-rabies immunoglobulin activity from horse serum. Drug development & registration. 2017; 4(21): 160–164 (In Russ.).