Quality Control in Freeze-Dried Powder Injection Production: Insights from Recent Conference
The China National Food and Drug Administration's Drug Certification Management Center recently convened a significant meeting in Shanghai focused on the quality control of freeze-dried powder injection production. This event marked the final gathering in a series of three on-site quality control conferences aimed at enhancing drug certification and management practices. Earlier meetings were held in Shijiazhuang and Chengdu, concentrating on traditional Chinese medicine injections and large-volume injections, respectively.
During this conference, representatives from the Drug Certification Management Center shared findings from inspections conducted on 151 pharmaceutical production companies. The inspections aimed to certify compliance with Good Manufacturing Practices (GMP), resulting in 124 newly approved GMP inspections. Notably, 33 large-volume injections and 22 freeze-dried powder injections successfully met GMP certification standards.
Currently, China boasts nearly 500 production workshops dedicated to freeze-dried powder injections. Despite the high number of facilities, less than 10% have achieved the newly revised GMP certification. Freeze-dried powder injections are created by freeze-drying a drug solution after it has been aseptically filled. However, it has been observed that some companies have not adequately validated their filling processes under worst-case scenarios, such as extended filling times, personnel shifts, and interruptions during filling. Additionally, the frequency of verification remains low, and advancements in environmental monitoring are inconsistent, failing to embody effective quality risk management practices.
Experts at the meeting emphasized the importance of ensuring sterility in freeze-dried powder for injection, noting that this aspect requires heightened attention from manufacturers. Companies such as Shanghai First Biochemical Pharmaceutical Co., Ltd., Livzon Group, Jiangsu Aosikang Pharmaceutical Co., Ltd., Hangzhou Australasia Biotechnology Co., Ltd., Zhejiang Hisun Co., Ltd., and Beijing Saisheng Co., Ltd. presented their approaches to risk assessment and management during the conference.
Understanding Freeze-Drying Process and Its Advantages
Freeze-drying, or lyophilization, is a process that involves removing a significant amount of water from materials by first freezing them and then sublimating the water vapor under vacuum conditions. This technique is particularly advantageous for heat-sensitive substances due to the low temperatures involved. The benefits of freeze-drying include:
Preservation of Heat-Sensitive Compounds: The low-temperature process is ideal for substances that may degrade at higher temperatures.
Minimal Loss of Volatile Components: Freeze-drying allows for the retention of volatile compounds, making it suitable for various chemical products, pharmaceuticals, and food items.
Microbial and Enzymatic Inhibition: The process prevents the growth of microorganisms and enzymatic activity, preserving the original characteristics of the material.
Structural Integrity: The volume of the material remains nearly constant during drying, maintaining its original structure and preventing condensation.
Rapid Rehydration: The resulting dried product is porous and spongy, allowing for quick and complete dissolution upon the addition of water, restoring its original properties almost instantly.
Protection from Oxidation: The vacuum environment reduces oxygen exposure, safeguarding easily oxidized substances.
Long Shelf Life: Freeze-drying eliminates over 95-99% of water content, enabling long-term storage without deterioration.
Given these advantages, freeze-drying is extensively utilized across various sectors, including pharmaceuticals, food production, and scientific research, highlighting its critical role in maintaining product quality and safety.
In conclusion, the recent conference underscored the importance of stringent quality control measures in the production of freeze-dried powder injections, while also showcasing the benefits of freeze-drying technology in preserving sensitive materials. As the industry continues to evolve, ongoing collaboration and adherence to GMP standards will be essential for ensuring the safety and efficacy of pharmaceutical products.
November 11, 2024
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