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The new GMP issued will undoubtedly improve the requirements of the pharmaceutical industry

To further improve the level of the pharmaceutical industry in our country, prompting companies to strengthen management and for the standardized operation, pay attention to the quality of the enterprise provides a good environment for development. In recent years, the industry have a significant policy, especially the new GMP issued, by the industry is called "history's most strict GMP.

The new GMP issued will undoubtedly improve the requirements of the pharmaceutical industry, and mainly lies in the new drug GMP certification is closer to international standards, requirements for enterprise production equipment and management level is also higher. Not only to the production environment, equipment, facilities, file management, risk control and a series of process put forward clear requirements, and in the process of drug production, a new version of GMP is explicitly put forward the stringent standards, big filter link is one of the important and difficult.

For example, in the process of infusion production, due to the infusion into the human body, which will be in direct contact with human body blood, this dooms one link to guarantee the whole sterile. If little slack in the transfusion filter link, it will bring to patients of heat reaction, reaction heat production caused by endotoxin, due to the violation of operating procedures, lead to microorganisms, all kinds of liquid or liquid particles such as heat source pollution caused by the quality control is lax patients with high fever, chills, and a series of heat reaction, the reaction is most common in clinical.

Therefore, in the process of clearing heat, it has to be its comprehensive adsorption activated carbon for medicine. However, the used activated carbon must also need to deal with clean, in order to guarantee the safety of transfusion. Therefore, it still must be removed  after the absorption of activated carbon, and in the river closure this link will need to use medicine special activated carbon filter cardboard. ...

The pharmaceutical enterprises must pay attention to the new GMP has explicitly put forward small material quality of filter cardboard products, especially to pay attention to the product composition of filter cardboard must comply with GMP requirements. It is the key to the GMP certification program, the general project. Pharmaceutical companies on the use of filter board must clarify requirements products have appropriate filtering effect.

Expressly in GMP * 3024 key project "to ban the use of containing asbestos filtration equipment," any pharmaceutical companies that do not ignored, especially in terms of the front with a "*" is a key to GMP project is not a general project, drug firms must be taken seriously. First, a high quality of filter cardboard products on the component must comply with GMP standard. Second, it  must have corresponding clarification filtration effect when using , if you have any special needs, the enterprise also requires a cardboard bactericidal effect.

Now on the market most of the medical special cardboard basically activated carbon can be removed, but the deficiency is the filter cardboard containing asbestos ingredient. In the provisions of the new version of GMP, pharmaceutical filter cardboard containing asbestos ingredients has serious defect, the filter will produce activated carbon cast, and the body to absorb the structure can cause discomfort, various organs after confirmed by the world health organization (who) and asbestos containing carcinogenic ingredients. The new GMP standard increasingly severe, medicine containing asbestos special filter cardboard will be a key player object, but if companies ignore the GMP standard of filter cardboard, there will be a big risk in the process of GMP certification.

Predictably, the improvement of the new GMP standard, the future medicine special filter cardboard containing asbestos ingredient exit the market or just a matter of time, and do not contain asbestos composition medicine filter cardboard is bound to become a major trend in the future, because it can not only meet the needs of the new GMP conditions, and have more obvious filtering effect, more safety and health.

At present domestic product does not contain asbestos medicine special filter cardboard a handful of enterprise, and in the new GMP, pharmaceutical companies have a huge demand for non-asbestos filter cardboard. Under the opportunity, with the implementation of the new version of GMP and thorough, do not contain asbestos composition medicine special filter cardboard inevitably become the darling of the market, get the favour of pharmaceutical enterprises.                                             

                                         (the author is province GMP certification inspectors)