How to carry out GMP transformation for small and medium-sized enterprises?
Shanghai Nena Environmental Protection Technology Co., Ltd. www.nclep.com.cn
Currently, one quarter of pharmaceutical companies in China have passed GMP certification. Obtaining a GMP certificate is not only a legal requirement but also helps companies improve their quality management level, product quality, and credibility, thereby enhancing market competitiveness.
As we all know, for companies whose hardware does not yet meet GMP requirements, whether it's the design party, construction party, or even the enterprise implementer, they would rather completely or partially avoid renovating old factories and instead build new ones. However, for the three quarters of companies that have yet to pass GMP certification, especially those small and medium-sized old pharmaceutical factories with insufficient funds, poor operating conditions, and survival difficulties, due to differences in factory history, equipment conditions, production processes, and management levels, each company faces different difficulties and pressures at this stage. Most should choose to renovate on-site based on local conditions.
Hardware is the material foundation of GMP certification, and most manufacturers consider the hardware transformation for GMP as the "bottleneck" they invest the most time, effort, and finances in overcoming. Meanwhile, due to certain misunderstandings about GMP certification, particularly regarding the scope, depth, and cost of hardware transformation, the GMP technical renovation and application certification process has been delayed or obstructed, preventing the economical implementation of GMP transformation. This article aims to briefly explain the possible misconceptions and difficulties companies may encounter during the implementation of GMP hardware transformation, as well as which types of companies can conduct GMP transformations on-site and how to carry out GMP transformations.
Misconception One: "GMP standards are too high to achieve"
In reality, GMP standards are an internationally recognized systematic and scientific management system for pharmaceutical companies, serving as the basic criteria for drug production and quality management. GMP is the unified basic requirement for quality management and quality assurance for pharmaceutical manufacturing enterprises in China.
Carefully analyzing the current situation and clearly defining the method and content of the transformation is crucial for companies transforming old factories. The technical transformation of old factories is limited by existing conditions or funds and cannot be compared to building a new factory. Some companies often think: poor conditions in the old factory - demolish and rebuild or relocate and expand - unable to raise large amounts of funds - wait and see.
There is more than one way to pass GMP certification. Improving the operating environment should not blindly pursue high standards in any single aspect. The desire to implement GMP should not solely rely on high-standard factories and air conditioning facilities, as this is neither comprehensive nor economical. Instead, it should be carried out according to the principles of compliance, economy, and practicality based on the actual situation of the enterprise.
Misconception Two: "GMP workshops are too expensive to build and maintain"
Some companies blindly pursue high standards and high investment during the preparation for GMP certification, increasing the cost burden during implementation and subsequent operations. For some companies, the end of certification marks the beginning of shutdowns or losses. Other companies underestimate the investment required, leading to halted projects halfway through. Major manifestations of high investment include: blindly upgrading purification levels, expanding clean area sizes, and improving decoration standards.
Industry experts believe that for every meter extended in a clean room, engineering costs increase by about 20%; for every upgrade in purification level, engineering costs increase by about 30%, and operational costs increase by about 35%. Therefore, companies must carefully consider their investments. Choosing an appropriate scale and suitable purification decoration standard is not only related to the initial transformation but also affects future operational costs.
Misconception Three: "GMP certification requires updating all equipment"
The advancement of equipment indeed helps ensure product quality and improve production efficiency, and equipment updates should be encouraged. However, this does not mean that all existing equipment fails to meet GMP requirements. In fact, after long-term production testing, the original equipment has already adapted well to the requirements of the original product process. By addressing the defects ignored during the design of the equipment and conducting relevant equipment and process validation, proving that it meets both product process and GMP requirements, the equipment can be effectively utilized in production.
Misconception Four: "As long as the hardware is good, software and management will be easy"
Many companies, after completing the hardware, are unwilling to spend more time and manpower on software construction and management standardization to cope with GMP certification, hastily copying the software from companies that have already passed GMP certification, thus failing to adapt it to their own situation. In fact, software and management are just as important as hardware. After one-time hardware construction, without effective management and scientific software, the hardware cannot function properly and may even create hidden dangers for production and quality. This is also the aspect where the most problems arise during GMP inspection and certification.