The regulatory changes for GMP air conditioning system validation in 2025 mainly come from the draft for soliciting opinions on the sterile drug appendix of the "Good Manufacturing Practice for Drugs (Revised in 2010)" issued by the National Medical Products Administration, as well as the upcoming new industry standards. The specific changes are as follows:
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Transitioning from static verification to "dynamic static combination" full process verificationAccording to the draft of the sterile drug appendix for comments released in March 2025, the validation of airflow patterns in air conditioning systems needs to be changed from a single static validation to a combination of dynamic and static validation. It emphasizes the evaluation of the impact of operational interventions on airflow. Enterprises need to equip visual recording equipment, leave traces through videos, establish a standard scenario library for dynamic simulation operations, and apply the verification results in a closed-loop manner to production quality control.
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Adjust the frequency of reconfirmation for the clean area air conditioning systemAccording to the draft for soliciting opinions on the appendix of sterile drugs, the A/B level clean area air conditioning system needs to be reconfirmed every six months, while the C/D level needs to be reconfirmed once a year. Unlike the previous practice of relying solely on annual quality reviews to maintain verification status, it places greater emphasis on periodic evaluations of the stability of air conditioning systems. At the same time, regulations do not mandate the use of the "one static, three dynamic" mode or the setting of a maximum number of dynamic verifications for each reconfirmation, allowing companies to develop differentiated verification plans based on pollution control strategies and risk assessments.
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New technical specifications added to the "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry"The "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry" released in 2025 will come into effect on September 1st. It is stipulated that the exposed air ducts in the medical clean area should be made of stainless steel material. At the same time, it is required to debug the operating mode and control system of the purification air conditioning system, and clarify that the operating parameters of the purification air conditioning system must be traceable and automatically adjustable, and manual data recording is no longer recognized as GMP system assessment records.
In the field of pharmaceutical production, compliance and efficient operation have always been the key to the development of enterprises. In 2025, the GMP air conditioning system validation regulations have undergone a series of important changes, which pose new challenges to the environmental control of pharmaceutical production enterprises. Suzhou Yikang Environmental Testing Co., Ltd., as a professional third-party testing institution in the industry, relies on a professional technical team and rich practical experience to provide enterprises withAccurate air conditioning system verification services help enterprises cope with regulatory changes calmly, ensuring stable and compliant production environments