Interpretation of the <i>Guideline for Pharmaceutical Excipients of Animal Origin</i>

SUN Chunmeng; CHEN Lei; LI Yanan; SONG Zonghua; YANG Zhaopeng; TU Jiasheng

doi:10.11665/j.issn.1000-5048.20220316

Journal of China Pharmaceutical University > 2022 > 53(3): 376-382. > DOI: 10.11665/j.issn.1000-5048.20220316

SUN Chunmeng, CHEN Lei, LI Yanan, SONG Zonghua, YANG Zhaopeng, TU Jiasheng. Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin[J]. Journal of China Pharmaceutical University, 2022, 53(3): 376-382. DOI: 10.11665/j.issn.1000-5048.20220316

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Interpretation of the Guideline for Pharmaceutical Excipients of Animal Origin

1.
National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009
2.
Chinese Pharmacopoeia Commission, Beijing 100061, China

Funds: This study was supported by the Chinese Pharmacopoeia Commission (No.ZG2017-5-03) and the Ministry of Science and Technology of China (No.2017ZX09101001006)

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Received Date: February 16, 2022
Revised Date: April 27, 2022

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Abstract

Abstract

Pharmaceutical excipients of animal origin, an important part in pharmaceutical excipients, are widely used in pharmaceutical preparations.However, compared with the pharmaceutical excipients of other origins, pharmaceutical excipients of animal origin have more special requirements in many aspects, such as raw materials, production, quality control, storage, supervision, etc.Chinese Pharmacopoeia 2020 first included the Guideline for Pharmaceutical Excipients of Animal Origin, which introduces the basic ideas and technical requirements for the life cycle quality control of pharmaceutical excipients of animal origin based on the risk management concept.This article illustrates the specificity of the pharmaceutical excipients of animal origin, and interprets the main contents of this guideline in conjunction with relevant domestic and foreign regulations and technical documents, thereby providing comprehensive reference for the implementation of the guideline.
- pharmaceutical excipients of animal origin,
- guideline,
- quality control,
- risk management,
- life cycle

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