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1 Whole Process Quality Management? No Idea
During the inspection of the extension of the validity period of the drug GMP certificate, I encountered a manufacturer of injections, and did not inspect and control the amount of water used for bottle washing during the initial and fine washing processes of bottle washing. Even if it is the initial washing, if it does not meet the requirements, it will affect the next step of fine washing and even affect the whole process. If this batch washes 5,000 bottles, what is the degree of pollution of the bottles? How much water should be used? After the initial washing with these waters, when do you need to replace them with new water? Some companies even recycle the fine washing water and return it for rough washing. This is not acceptable because the water has been polluted. All these processes need to be included in the strict quality control of the whole process. Interpretation by inspectors: Aseptic guarantee is not just a problem of a certain link, advanced hardware equipment, raw material quality control, environmental monitoring, aseptic guarantee in the whole production process, online monitoring, etc., this is a whole process of quality management and control.
2 Quality Risk Awareness? What’s That?
During the on-site inspection, the laboratory operators who had seen tumor drugs put on gas masks to operate, and it seemed that safety precautions were well done. At this time, during the weighing operation, a drop of liquid splashed on the weighing platform, and the weighing platform was directly above the vent. The operator took a rag, wiped off the splash, and then put the rag aside. No other measures were taken. No further risk analysis, does the rag have powder on it? Will spilled fluid cause contamination through the vents? During the inspection, there is a company that has passed the EU GMP certification not long ago. The file system established by the file version provided by their entrusted foreign company is quite good as far as I can see. However, during the inspection process, it was found that their personnel Lack of quality awareness. The company entrusted the local Center for Disease Control and Prevention to inspect the drinking water, and the Center for Disease Control and Prevention issued a report that the water quality indicators were unqualified. But they didn’t see it until we went to check it. Water, which is equivalent to your raw material, must be audited, inspected, and the reasons for unqualified products must be found out, and then controlled. It can be seen here that there is a vacancy in their quality management system, which can also be said to be the lack of quality awareness of personnel. In addition, the production director of the company had been chewing gum in the production area while accompanying the inspection. Even if the minister has strong professional ability, how can he be considered high in quality risk awareness? Inspector’s Interpretation: The quality risk awareness is not really implemented and understood. No matter how beautiful the document system is, it is just a pile of documents without real effective implementation; the level of professional ability does not mean that the quality risk awareness must be strong; companies that have passed the EU certification may not necessarily do well done.
3 Clean Corridors? Can Be Used Anywhere, Very Good!
Some sterile preparation companies blindly set up clean corridors. The clean corridor is usually used in the production workshop of solid preparations. Its purpose is to prevent dust pollution in some multi-variety or dust-producing workshops. If the pressure difference between the operation rooms is greater than that of the corridor, the dust in the operation room will be Flow into corridors, which can contaminate other areas. Therefore, it is required for such a workshop to form a certain negative pressure in the operation room relative to the corridor, so that the dust pollution of solid preparations can be controlled. On the contrary, in the production of sterile preparations, this clean corridor is not necessary. Only in some links, such as weighing systems and other links that will generate dust, clean corridors are required, but not all operating rooms need to be equipped with clean corridors. Don’t understand the core of setting differential pressure gradient: The new version of GMP proposes this concept for solid preparations. The core of differential pressure gradient setting is to control contamination and cross-contamination. The design of the early clean workshops in our country was unreasonable, and the pressure gradient was often not considered in the design of the air conditioning system. In the past, it was only stipulated where there should be a differential pressure gauge, and then the company would install a differential pressure gauge here according to this regulation; if you say it is greater than 10P, I will be greater than 10P, and if there are no other regulations, I will not care. The company did not consider the basic core of preventing pollution from the differential pressure gradient, but only placed it in compliance with the basic provisions of GMP at that time. But this situation still exists. During the inspection, we found that some solid preparation companies did not fully understand this. He put a differential pressure gauge and still didn’t understand the meaning. GMP stipulates that the clean area is 10P larger than the unclean area, so he adjusted the high pressure difference, which is greater than 10P in numbers. But he doesn’t pay attention to the air flow in the clean area.
4 It Is Enough To Modify The Defective Item, And It Needs To Be Archived? What Words!
“A sterile preparation company that produces powder injections received a batch of materials. The operator opened two barrels of materials and found that there was a problem (the powder injections were packaged separately). So he removed them, but the other Use the rest.” This is definitely a serious flaw. One is the high risk of the variety, and the other is that when this situation is discovered, first of all, all this batch of materials should be stopped. This batch of materials cannot be canned. To find out the reason, or even to find out this batch and the next batch of materials, you need to contact the supply business contact. This shows that the quality management system of the enterprise has been destroyed, and the quality awareness of personnel is very weak. The 2010 version of GMP inspection needs to be judged based on the overall situation, the degree of risk of the variety, the situation on the spot, and the situation of the enterprise. If there is a problem with the purified water system, if it is water for injections, it is a serious defect; if it is external preparations, water for oral products, it is not a serious defect. It is also necessary to look at the whole to see whether it happens by accident or often, or whether there are problems in all links; such as product problems, whether there is a problem with one batch number by accident, or problems with multiple batches, and whether the deviation has been corrected in time , Change Have you carried out effective control measures, have you carried out risk assessment, and what are the tools for risk assessment. Several elements of the quality management system identified issues but did not address them, which I consider at least a deficiency. In fact, it is relatively rare to find serious defects in solid preparations, unless there are violations of laws and regulations, or something flawed, which may appear in hardware or personnel qualifications. It does not necessarily mean that there are no serious defects. We will make a comprehensive judgment based on the main defects. Through this judgment, we will know the overall situation of your enterprise.
5. A Good Memory Is Not As Good As A Bad Pen. I Wrote And Recorded It, And That’s It! I Don’t Understand It, It Doesn’t Matter…
There is still a rote phenomenon in the establishment of software. When the 98 version comes, I will put the hardware; when the 2010 version comes, I will build the file. If you want a quality review, I will write it down, and if you want a deviation, I will also write it down. I have seen a company whose deviation is very well written, but why do I do it? Which are the deviations? But I don’t know what to ask, and I don’t know where to copy the template. When inspecting the filling workshop on site, I happened to see a vial on the transportation line, which fell off with a snap and broke. The operator just swept it away. Ask him if this is an abnormality or a deviation in production? He said it was a deviation, but he just didn’t pay attention. And without further analysis, it’s over. For example, the air-conditioning system, some enterprises’ SOP clearly writes how often we clean the filter, and when the pressure difference reaches a certain value, it will not be used or replaced. These are all memorized. But when I asked her on the spot why the pressure difference was getting higher and higher, she said that it was blocked, and what to do if it was blocked, she didn’t know. Many people write on the SOP on the back of the machine, such as checking the temperature setting on site, the temperature is 50 degrees plus or minus 2 degrees, ask him, where do you adjust? He said, our machine is 50 degrees plus or minus 2 degrees. Interpretation by inspectors: If you ask three questions and don’t know, the main defect may also be a serious defect.