GMP upgrading: the standard of sterile drugs should be improved

The new version of GMP expert revision has completed the evaluation and demonstration The focus of this revision of GMP standard is to refine the software requirements There is no change in the hardware requirements for other drug production, but the requirements for sterile drug standards have been greatly improved "At present, the evaluation and demonstration of the revised expert version of the new GMP has been completed, and is now being summarized and summarized At that time, opinions may be formed and submitted to the State Council." Recently, at the "China world pharmaceutical forum" held in Shanghai, experts from the safety supervision department of the State Food and Drug Administration said It is reported that the demonstration work is mainly to comprehensively evaluate the advantages and disadvantages of the revised standard for enterprises, but the revised terms will not be revised temporarily The latest version of GMP expert revision focuses on refining software requirements to make it more operable In addition to the latest A, B, C and D classification standards of the European Union and who, and specific requirements for cleanliness level, the hardware requirements for other drug production have not changed in this revision It is understood that the revised GMP involves basic requirements and five appendixes of sterile drugs, traditional Chinese medicine preparations, APIs, biological products and blood products The annex requirements of non sterile drugs in the original 98 version GMP are incorporated into the basic requirements Due to the improvement of aseptic drug standards, relevant enterprises may need to make some necessary investment in hardware Since the appendixes such as Chinese herbal pieces, radioactive drugs and medical gases in the 98 version of GMP are not revised temporarily, they will continue to be used, and those that do not adapt to the new version of GMP will follow the new version At that time, there will be one basic requirement, five new appendixes and three old appendixes for GMP implementation As for the appendix of biological products, according to the characteristics of biological products production, the new GMP emphasizes a series of requirements on strict control of production process and intermediate process, as well as on prevention of pollution and cross pollution, and strengthens production management, especially the management requirements for seed batch, cell bank system, production operation and specific requirements for raw and auxiliary materials The appendix of blood products is a new appendix of the new GMP, which focuses on ensuring the safety of raw plasma, intermediate products and finished blood products, re inspection of raw plasma, setting of quarantine period, tracing of blood supply plasma personnel information and product information, inspection of safety indicators of intermediate products and finished products, management of in vitro diagnostic reagents for inspection, feeding production, virus inactivation and non conformity The specific requirements for ensuring the safety of raw plasma, intermediate products and finished products are put forward in every link such as plasma treatment The appendix of traditional Chinese medicine preparation strengthens the quality control, extraction process control and storage management of traditional Chinese medicine and herbal pieces, and puts forward comprehensive requirements for the quality control items of traditional Chinese medicine and traditional Chinese medicine preparation and the control of recovered solvent in extraction In addition, the revision of API appendix is mainly based on Q7 of ICH Meanwhile, the content of Q7 which is repeated with the basic requirements is deleted, and the special requirements for API are retained API appendix strengthens the software requirements, adds the control standards of classical fermentation process, and specifies the specific requirements of API recovery, rework and reprocessing It is reported that in the process of revision of the new GMP basic requirements and five appendixes, the management of documents has also been strengthened, and chapters such as drug quality authorized person, design confirmation, change control and deviation handling have been added with reference to international GMP standards, with a view to strengthening the control and management of relevant links by domestic enterprises In addition, it also introduces or clarifies the concepts such as the investigation of excessive results, supplier audit and approval At the same time, considering that the current GMP is not closely related to drug registration management, adverse drug reaction monitoring, drug inspection and other related regulatory work, the revised GMP also strengthens the relationship between GMP and drug registration and post marketing supervision, so that the relevant requirements are matched with the latest "drug registration management measures", "drug recall management measures" and other regulations, and strengthens the Drug registration requires strict implementation in drug production In addition, the new GMP has greatly increased the regulatory requirements for post marketing drugs According to this requirement, enterprises must establish a system of corrective and preventive measures, introduce product quality review and audit, and continuous stability inspection plan to ensure the quality of drugs within the validity period Demonstrate the impact of the main assessment on the enterprise The reporter learned from the forum that the evaluation and demonstration work of the revised version of GMP experts are mainly carried out at three levels: first, Jiangsu, Jilin, Shaanxi and Sichuan are selected as pilot provinces to jointly carry out the evaluation and demonstration of the revised terms with the local provincial Bureau; second, each provincial food and drug administration organizes the investigation and evaluation based on the actual situation of drug production within its jurisdiction Third, invite some professional associations to organize special demonstration and evaluation A former member of the GMP and GSP certification group of the State Food and Drug Administration told reporters that this time it was only an internal evaluation and no public consultation had been conducted It is a trend for GMP standard to be in line with the international standards, which is the need for upgrading the domestic pharmaceutical industry, and also the "threshold" that must be crossed for the preparation to go abroad The improvement of the standard needs a process From the internal certification evaluation, it can be seen that the new GMP is close to the international standard, but also takes into account the actual situation in China and the tolerance of enterprises An expert from an industry association in Beijing who participated in the revision of the standard told the pharmaceutical economic news that the new GMP standard has lagged behind the international standard since 1998, so it is really necessary to revise it For example, the aseptic guarantee required by aseptic preparation is directly related to drug safety During the interview, the reporter learned that the certification evaluation mainly based on the revised standards, explored the number of enterprises to be transformed, the average investment, the transformation time, and the impact on the production and operation of enterprises and product market supply, and preliminarily estimated the number of enterprises unable to pass the transformation "The new GMP will strive to seek public opinions this year This version is basically equivalent to wh0 and EU GMP standards in terms of technical requirements, but it also makes corresponding adjustments in terms of specific provisions in combination with China's national conditions For example, for the production of sterile products and the monitoring of suspended particles, the EU standard is continuous monitoring, and the newly revised GMP clause is set as frequent monitoring The main reason is that the continuous monitoring mode needs to be equipped with many on-line monitoring equipment, which is expensive and costly to be modified, and the production capacity and level of the existing monitoring equipment in China still cannot meet the above requirements " Said the expert of the safety supervision department.