Figure 1.  Flow chart of the cross-contamination risk management process

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РАЗРАБОТКА И РЕГИСТРАЦИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ. 2022. Т. 11, № 1
DRUG DEVELOPMENT & REGISTRATION. 2022. V. 11, No. 1
REFERENCES
1. 
Ob utverzhdenii Pravil nadlezhashchey proizvodstvennoy praktiki: 
Prikaz Minpromtorga Rossii ot 14.06.2013g. № 916 (s izmeneniyami 
na 18.12.2015 g.): zaregistrirovano v Minyuste Rossii 10.09.2013 
№ 29938
[On the approval of the Rules of Good Manufacturing 
Practice: Order of the Ministry of Industry and Trade of Russia 
dated 14.06.2013 No 916 (as amended on December 18, 2015): 
registered with the Ministry of Justice of Russia on September 10, 
2013 No. 29938]. Available at: http://www.consultant.ru. Accessed: 
18.08.2021. (In Russ.)
2. Podpruznikov Yu. V., Shestakov V. N. Review, characteristics and 
analysis of the last changes in the GMP requirements. 
Razrabotka 
i registratsiya lekarstvennykh sredstv
= 
Drug development & registra-
tion
. 2016;(3):202–218. (In Russ.)
3. 
Ob utverzhdenii Pravil nadlezhashchey proizvodstvennoy praktiki 
Evraziyskogo ekonomicheskogo soyuza: Reshenie Soveta Evraziyskoy 
ekonomicheskoy komissii ot 03.11.2016 № 77 
[On approval of the 
Rules of Good Manufacturing Practice of the Eurasian Economic 
Union: Decision of the Council of the Eurasian Economic 
Commission dated 03.11.2016 No 77]. Available at: http://www.
consultant.ru. Accessed: 18.08.2021. (In Russ.)
4. EudraLex Volume 4 EU Guidelines for Good Manufacturing 
Practice for Medicinal Products for Human and Veterinary Use. 
2015. Available at: https://ec.europa.eu/health/documents/
eudralex/vol-4_en. Accessed: 18.08.2021.
5. Sargent E. V., Flueckiger A., Lovsin Barle E., Luo W., Molnar L. R., 
Sandhu R., Weideman P. A. The Regulatory Framework for Preven- 
ting Cross-Contamination of Pharmaceutical Products: History 
and Considerations for the Future. 
Regulatory Toxicology and Phar-
macology: RTP
. 2016;79(1):S3–S10. DOI: 10.1016/j.yrtph.2016.05.029.
6. ICH guideline Q9 on quality risk management: EMA/CHMP/
ICH/24235/2006 – 2015. Available at: https://ich.org/page/quality-
guidelines. Accessed: 18.08.2021.
7. 
Prikaz Minpromtorga Rossii ot 12.12.2013 № 1997 "Ob utverzhdenii 
Rekomendatsiy po organizatsii proizvodstva i kontrolya kachestva 
lekarstvennykh sredstv"
[Order of the Ministry of Industry and 
Trade of Russia dated December 12, 2013 No. 1997 "On approval 
of the Recommendations for the organization of production and 
quality control of medicines"]. Available at: http://www.consultant.
ru. Accessed: 18.08.2021. (In Russ.)
8. ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Phar-
maceutical Products (Risk-MaPP). Makati: International Society for 
Pharmaceutical Engineering; 2017. 178 p. 
9. How safe is your process? The usual causes of pharmaceutical 
contamination. Pharmaceutical Technology. 2018. Available at: 
https://www.pharmaceutical-technology.com/powder-handling/
causes-of-pharmaceutical-contamination. Accessed: 15.09.2021.
10. ICH guideline Q10 on pharmaceutical quality system EMA/CHMP/
ICH/214732/2007 
– 
2008. Available at: https://ich.org/page/
quality-guidelines. Accessed: 18.08.2021.
11. Spiridonova A. A., Khomutova E. G. The risk-oriented approach 
in the quality management system of an industrial enterprise: 
the problem of selecting the methods of risk management. 
Organizator proizvodstva 
= 
Organizer of Production.
(In Russ.) 
2017;25(2):92–100. DOI: 10.25065/1810-4894-2017-25-2-92-100. 
12. 
GOST R 58771-2019 "Menedzhment riska. Tekhnologii otsenki riska"
[GOST R 58771-2019 "Risk management. Risk Assessment Techno- 
logies"]. Moscow: Standartinform; 2020.146 p. (In Russ.)
13. Spiridonova A. A., Rudakova V. A., Khomutova E. G. Quality risk 
management of immunobiological drug production under culti-
vation conditions.
 Biofarmatsevticheskiy zhurnal
= 
Russian Journal 
of Biopharmaceuticals
. 2019;11(4):54–60. (In Russ.) DOI: 10.17513/
np.407.
14. Inspection of health based exposure limit (HBEL) assessments 
and use in quality risk management: AIDE-memoire PI 052-1. 
Secretariat of the Pharmaceutical Inspection Convention. 2020. 
Available at: http://www.picscheme.org. Accessed: 08.08.2021. 

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