Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.
As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.
a School of International Pharmaceutical Business, China Pharmaceutical University , Nanjing , PR China.|b The Drug Registration Division, China Food and Drug Administration , Beijing , PR China.
Maozhong
M
Li
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.
Yunai
Y
Du
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.
Qiyue
Q
Wang
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.
Chunmeng
C
Sun
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.
Xiang
X
Ling
a School of International Pharmaceutical Business, China Pharmaceutical University , Nanjing , PR China.|d School of Traditional Chinese Pharmacy, China Pharmaceutical University , Nanjing , PR China , and.
Boyang
B
Yu
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.
Jiasheng
J
Tu
c State Key Laboratory of Natural Medicines, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University , Nanjing , PR China.|e School of Sciences, China Pharmaceutical University , Nanjing , PR China.
Yerong
Y
Xiong
D000284:Administration, Oral; D005079:Excipients / Q000008:administration & dosage / Q000009:adverse effects* / Q000633:toxicity; D017143:Fuzzy Logic; D006801:Humans; D007267:Injections; D011136:Polysorbates / Q000008:administration & dosage / Q000009:adverse effects* / Q000633:toxicity; D018570:Risk Assessment / Q000379:methods*
D005079:Excipients; D011136:Polysorbates
AHP-fuzzy comprehensive evaluation; pharmaceutical excipients; quantitative risk assessment; risk assessment; supply chain