The implementation requirements of new version veterinary drug GMP has been released, all manufacturers should meet the new version of veterinary drug GMP requirements by June 1st, 2022!
The old verison is released in 2002,which has been 17 years till now. It should be said that with the great development of the veterinary drug industry in these years, the 2002 version of the veterinary drug GMP has obviously failed to meet the needs of the industry.Combining the experience of GMP implementation in Europe and the United States and our practice over the years, let’s see the the main changes for chinese veterinary drug industry and influence for us:
Change 1st: Optimize the inspect structure.
Clarify the specific production quality management standards for various products, further refine the principled provisions of the main text, and enhance the guidance and operability.
Change 2nd: Improve the production standards of sterile veterinary drugs and veterinary biological products.
In order to improve the sterility assurance level of aseptic products, effectively control the safety risks of animal drugs, increase the online monitoring requirements of the production environment, and improve the product quality assurance level.
Change 3rd: Improve the requirements for the production facilities of special drugs.
The production of external pesticides and flammable, explosive and corrosive disinfectants should use independent buildings, production facilities and equipment, and be strictly separated from the production of other types of veterinary drugs.
Change 4th: Improve and refine the software management requirements.
The requirements for enterprise quality management software have been increased, and quality risk management,change control, deviation handling and other systems have been introduced to ensure the quality of veterinary drug products in many ways.
Influence 1st: Better quality
Implement dynamic and continuous supervision and management on manufacturers,it means stricter requirements on production environment and facilities,in this situation,the API quality will be greatly improved.
Influence 2nd:Price rises
Due to stricter regulations on production and rising costs,it may eliminate some small and medium enterprises,and meanwhile,product prices will change slightly as the quality improves.
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