A company must prepare a quality manual and related program documents and third level documents according to the requirements of the FDA QSR, to fully understand and comprehend the regulations, and to formulate system documents that are both compliant with the requirements and practical. The most important thing is to effectively implement these documents, organize the relevant historical records and information, the work must be rigorous, not superficial. To do a job, we must first ask ourselves why we do it? How to do? Who will do it? When to do it (including the time of completion)? {j\h}
Second, the FDA inspection focus: review of documents; according to the QSIT method - based on seven subsystems
4 main subsystems (management, design, corrective and preventive, and production process); 3 support subsystems (documents, materials, production tools and equipment control); FDA inspection The work will be carried out in a point, seize a point, may be in a problem a few back and forth, may also check the whole company's quality management system.'' jm
Three, in the FDA officials to the factory inspection before the company should carry out a number of internal verification and confirmation; for any company, through the FDA factory inspection of the most important condition is that they have to strictly implement the established procedures and operational processes, the document preparation of the reasonableness and operability is of course important to check the officials have the documents do not implement the most disgusting. Such things will certainly be on Form483. E
Four, the FDA process, especially in the special process of some key steps in the operating conditions, methods and equipment for the verification (Validation) is very important. But they pay more attention to process control, there should be operating instructions must be prepared; at least to be accompanied by people who know what they are doing, in case of a lack of documents, this time on the * know what they are doing on the spot, as long as they can say that you are actually operating, control methods, can convince the inspector, and generally get by, the observation may be there, but less likely to be used as a non-conformity, which they are not rigid.
Fifth, the FDA attaches great importance to the inspection of production records, warehousing of raw materials, inspection and issuance of production process control, quality inspection of finished products and the verification of key items are required to have a complete set of original records and batch records, FDA officials in the factory inspection to arbitrarily take samples of sampling batch records, batch records, authenticity and completeness of performance of the factory specifically reflects the level of GMP management. The authenticity and completeness of the batch records reflect the level of GMP management in the factory.
Sixth, FDA inspectors are very concerned about the control and handling of nonconforming products and customer complaints, the process and related records. The preparation of this must be sufficient, not a little sloppy, where the sharp tongue does not matter, there must be real evidence.
Seven, the receptionist to answer questions to have the skills, not clear things do not answer immediately, you can first check the documents, a few people to discuss the final answer. Do not be "inspired" to think that they can cope with, the next question may make you dumbfounded. I have seen reports: FDA inspectors in the factory inspection asked: your documents look how very new ah, the answer to the staff's bright idea: Oh, our documents are stored in plastic bags. Inspector no longer say anything, but to the last day, the inspector suddenly said: I checked in your factory for four days, but I never saw you hand me the documents using plastic bags for safekeeping. What else can you say at this point? %rNvk=a`
Eight, the results of the inspection: nothing, this is the best case, but I'm afraid this is unlikely. Can receive no criticism of the 483 form (no failure, only observations) has been quite good; to do not do a good job of the enterprise may receive a criticism of the 483 form, it is dangerous, it may lead to: Warning letter (Warning letter), automatic detention (Automatic Detention), QSR detention, (QSR Hold) withdrawal (Recall), up to permanent exclusion. Recall), until permanently prohibited from entering the U.S. market.
So, where the U.S. FDA notification to come to the factory of the enterprise please note that the need for the entire company's staff attaches great importance to the mobilization of all staff, full preparation, the possible failure to comply with the minimum, in order to avoid receiving a warning letter.