The risks analysis for definition of requirements to residual quantities of washing-up stuffs on the process equipment surface at the pharmaceutical enterprise
Keywords:
the risks analysis, FMEA, residual quantities of washing-up stuffs
Abstract
On the basis of the risks analysis by method FMEA «A failure modes and effects analysis» is defined risk of carrying over of the residual quantities of disinfectant washing-up stuffs in the next medicine and the limit of “Sokrena” and “Brilliant” on a process equipment surface is established. The procedure of residual quantities definition of the disinfectant washing-up stuffs containing quaternary ammonium compounds is developed.
References
1. "Attitude. Medicines. Good manufacturing practice. MO-H MO-42-4.0: 2010 ”. - K., 2010.
2. State Sanitary and Epidemiological Service of the Ministry of Health of Ukraine / Concerning the Analytical Review of Disinfectants and Antiseptics Permitted for Use in Ukraine / Letter N 04.2 / 946, 10.06.2003.
3. D.A. LeBlanc / Establishment scientifically justified acceptance criteria for cleaning validation of finished drug products / Pharm. Technol. 22 (10), 136-148 (1998).
4. State Pharmacopoeia of Ukraine. 2.4.1. Ammonium salts / State enterprise "Scientific Expert Pharmacopoeial Center". - Type 1. - Kharkiv: RIREG, 2001.
2. State Sanitary and Epidemiological Service of the Ministry of Health of Ukraine / Concerning the Analytical Review of Disinfectants and Antiseptics Permitted for Use in Ukraine / Letter N 04.2 / 946, 10.06.2003.
3. D.A. LeBlanc / Establishment scientifically justified acceptance criteria for cleaning validation of finished drug products / Pharm. Technol. 22 (10), 136-148 (1998).
4. State Pharmacopoeia of Ukraine. 2.4.1. Ammonium salts / State enterprise "Scientific Expert Pharmacopoeial Center". - Type 1. - Kharkiv: RIREG, 2001.
Published
2019-07-01
How to Cite
Shkliaiev, S., & Tshurkan, A. (2019). The risks analysis for definition of requirements to residual quantities of washing-up stuffs on the process equipment surface at the pharmaceutical enterprise. Farmatsevtychnyi Zhurnal, (3), 19-22. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/646
Section
Risk Analysis at a Pharmaceutical Enterprise
This work is licensed under a Creative Commons Attribution 4.0 International License.
