Industry news

Improve and speed up the process of China's GMP and international standards

Time：2017-04-16 11:53:16

       One, self-discipline. Is the enterprise to take the initiative to consciously adhere to the drug GMP management companies, adhere to standardized production. Clear enterprise is the first responsibility of drug quality concept. In practice, some enterprises don't know to the importance of execution of GMP in pharmaceutical production, in the enterprise implementation of the GMP process, certification and factory building, replacement of equipment, develop and document in the implementation of the GMP process lack of initiative and autonomy. Main performance: one is plant design of the enterprise and the product process does not adapt, equipment purchase does not match the scale of production; on plant and equipment daily maintenance do not attach importance to, the lack of corresponding operation, repair and maintenance records; certification before the assault fill fill in the record. Enterprises should be aware of the plant, equipment is the basis of drug production guarantee, plant, equipment is not perfect, it is difficult to ensure the normal production of drugs and product quality. GMP foreign countries to implement strict requirements from the plant design. Two is not to pay attention to personnel training, personnel training is considered to be a form of GMP certification needs. Training plan is vague, or plan is not implemented; training time hastily arranged, training content, training level, job, year in and year out a training, assessment of a problem. And the most active factor in the production of drugs is people. High-quality personnel, not only refers to highly educated, but with integration and enterprise culture idea and professionalism, grasp the combined with the reality of the enterprise theory and technology professionals. Three is to verify the lack of awareness, verification is to ensure that the quality of drugs, stability, an important experimental means. Verify the feasibility and stability of the drug production and operation control, and the rationality of the process parameters, the reliability of the test method, and ensure the quality of the products. And most of the enterprises in the verification work with blindness or to deal with. Blindness is not a clear understanding of what is the purpose of validation, in the selection of validation projects and control parameters from the company's actual, "imitate" other companies or some reference materials. The response is to verify that the program and verify the content of rough, some only do a set of data, there is no reproducibility, the results of the verification can not prove the reliability of equipment operation and the rationality of the process. The enterprise should integrate the verification work into the product research and development, in the research and development process into the GMP awareness. This is a common practice of foreign pharmaceutical companies. Four is developed in the paper from the actual, will be "parked" file change the head, of the enterprises and the actual situation of the management form "two pieces of skins", in the complex certification often see documents companies rarely revised, only changed the date of signature and version number, and content is still rough and operation. Production management still can not be separated from the management experience and habits, lack of awareness of files and system management; all notes fill are not in conformity with the provisions of the documents; file into the implementation of GMP certification and inspection "outfits." Five is the implementation of GMP is the whole process of monitoring the lack of awareness. The whole process of drug production monitoring is the essence of the implementation of GMP. Only for each process, each link is strictly "standardized" operation, in order to ensure the stability and uniformity of drug quality. "Qualified drugs are produced, rather than out of the" guiding ideology should run through. Some companies still focus on the final inspection; such as sterile formulation production; in each link of the process of microbes and particles of dust pollution control and loose, to final sterilization and aseptic filtration as a reason, control and verification of the microbial load number before filtration and sterile product risks increased. Oral preparation with non sterile and the risk of small clearance and cleaning work to relax. In the management of materials that as long as the finished product quality can not be used for full inspection, the use of the process of the lack of review. Six is to ignore the self inspection work. It is very necessary and significant for enterprises to use GMP throughout the whole process of drug production management. QA is the main responsibility of enterprise self inspection. Some enterprises ignore QA personnel allocation and training; QA personnel on drug production from the plant, equipment, materials storage, production, inspection, environmental control and validation of each link of the control key points and requirements should be familiar with, and most domestic enterprises to configure the QA staff quality low, enterprises in the certification examination with QA and check the end of the certification is doing other work.

      Thus enterprises in the certification inspection to produce the self inspection plans and self inspection records and reports, the meaning of the surface more, non enterprise's real practice. Foreign enterprises QA personnel quality requirements are higher, and often regularly to all aspects of the production process, the post, inspection in accordance with the GMP and the company's rules and regulations and are often organized various departments self-examination or between departments mutual inspection, so that the production and operation of enterprises always abide by GMP。

      Two, discipline. Is the drug regulatory authorities and GMP on-site inspection of the standardized management. Pharmaceutical producing enterprises only self-discipline is not enough, we must standardize the behavior of drug regulatory departments to develop regulations and on-site supervision, and this is the heteronomy. Regulatory authorities in the supervision of enterprises, not only to be strict, but also to regulate. Supervision is not standardized, it is not able to establish a long-term regulatory mechanism, regulators should adhere to the scientific. Scientific supervision is to be based on scientific theory, combined with the actual humane management. Drug regulatory authorities in the formulation, implementation of laws, regulations, policies should be in line with scientific theory. Such as GMP attestation spot check, it is necessary to strictly enforce the inspection standard, but also to understand the meaning of each inspection standards, only by understanding the meaning of each inspection standard, the inspector in the evaluation to do fair and impartial. Site verification not only for enterprises in the pharmaceutical production management GMP to make a fair evaluation, but also to deal with the implementation of the GMP process to supervise and guide the implementation of。

      Therefore asked the inspector's political quality and professional knowledge had a higher level, in the evaluation of enterprises should seize the varieties in the production process and the important link of the key control factors, not only from literal subjectively and dogmatic understanding terms of inspection. Proposed national certification management center for some of the inspection in the field of easy to produce a unified interpretation of the provisions of the examination to make a unified interpretation. Such as personnel is based on education, or with practical experience in management and production based, water for injection is 80 DEG C above heat preservation, cycling above 65 DEG C, both have reached, or to ensure that them together to take measures to ensure the water quality; material sampling room environment clean level is consistent with the requirements of the materials in the production of clean environment level, or consistent with the use of clean environment level. Our country GMP vice records (98 Edition) raw material medicine production environment clean level, in addition to aseptic packaging raw material requirements of fine, dry and package in class 100 clean environment to operate outside, other raw material medicine production environment clean level for Level 3 00000. In laboratory settings, in addition to the central laboratory, laboratory research and development, Chinese Herbarium, leaving like look outside, intermediate goods inspection chamber whether must separate from the pharmaceutical production; post operation method and standard operating procedures (SOPs) content of real distinction is what, in order to check the combination of our country's unified understanding, promote the development of our country GMP。