The Veterinary Bureau of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China issued the Soliciting Public Opinions on the Good Manufacturing Practice for Veterinary Drugs (Revised Draft for Comment) on June 14, 2019, which is something big to the veterinary drug industry of China because it will significantly affect thousands of veterinary drug manufacturers. And this new edition of GMP for Veterinary Drugs will continue to produce influence in terms of management philosophies, technical requirements and standards, and regulatory pressure on the industry, which sufficient attention shall be given to.
It has been 17 years since the 2002 edition of GMP for Veterinary Drugs was issued, which clearly cannot adapt to the industry development needs, with the big development of the veterinary drug industry all those years. The issuing of a new GMP for Veterinary Drugs is an irresistible trend as seen from the latest situations of veterinary drug enterprises.
I’d like to analyze for the veterinary drug industry the new characteristics and new requirements of this new edition of GMP for Veterinary Drugs according to my rich experience in the industry and in conjunction with the European and U.S. GMP implementation experience as well as the development practice of the veterinary drug industry all those years.
Firstly, quality risk management (QRM) is introduced to the new edition of GMP for Veterinary Drugs to promote the rational development of the industry. Quality risk quantization management has been a common and effective management method in Chinese and overseas pharmaceutical product management systems, which emphasizes control beforehand and prevention, manages and controls possible risks in each link of pharmaceutical production and controls critical-to-qualities with high risks in a targeted manner to stabilize product quality. There is no such requirement in the existing GMP, and the management is carried out mostly depending on experience, which is not good for controlling the quality risks. The National Medical Products Administration of China (NMPA) has joined the ICH on June 19, 2017 to become a member of its Management Committee. Predictably, China’s relevant regulation system will gradually draw on relevant guidelines of ICH in the future. The new edition of GMP for Veterinary Drugs stipulates in Articles 12-14 that veterinary drug enterprises shall adopt QRM. This new change will provide new requirements and tools for the management and practice of veterinary drug enterprises; Chinese veterinary drug enterprises shall implement the QRM work of veterinary drug management by actively adopting methods in ICH Q9.
Secondly, clean area standards have significant changes. The current 2002 edition of GMP for Veterinary Drugs adopts the British standards, i.e., clean area standards are separately class 100, class 10,000, class 100,000, and class 300,000, which are outdated and contain only static requirements but no dynamic requirements. The new edition of GMP for Veterinary Drugs adopts the EU standards to divide clean area standards into class A/B/C/D and add static and dynamic standards of suspended particle item. Those new changes will produce significant effects on aseptic veterinary drug enterprises, vaccine enterprises, and biological product enterprises. Many enterprises may need to transform their plant buildings to adapt to new requirements. Furthermore, pharmaceutical industry design entities will be busy with their business in the next two years.
Thirdly, regulated management of data is a focus. Article 3 of the draft of the new edition of GMP for Veterinary Drugs stipulates: enterprises shall implement this GMP strictly and adhere to honesty and trustworthiness and are prohibited from any falsification and fraudulence, which are issues veterinary drug enterprises must pay sufficient attention to and the foundation for the implementation of the GMP for Veterinary Drugs. Chinese veterinary drug enterprises have long been "small, scattered and disordered", however, the relevant veterinary drug industry must treat the issues...
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