Notice of the State Drug Administration，The quality supervision of biochemical drugs has been raised to the GMP level。

 

  On October 19th, the CFDA General Administration released the "Appendix Appendix of Drug Production Quality Management Standardment Biochemical Drugs" (Draft for Solicitation) (hereinafter referred to as & ldquo; Biochemical Drugs GMP Appendix & RDQUO;)。This is after the flight inspection of three biochemical drugs in September、This is also the "Notice on the Requirement of the Basic Technical Requirements on the release of the basic technical requirements for the release，The General Administration of CFDA finally put forward new requirements on the quality management of biochemical drugs。

 

  Biochemical drugs are mostly & ldquo; Auxiliary medication & rdquo; or & ldquo; key monitoring drugs & rdquo;

 

  Notice on the Release of Basic Technical Requirements for the release of the basic technical requirements for the release，defines & ldquo; multi -components of degeetic drugs & rdquo;、Animal tissue or body My stake betting appfluid，Or a drug with a non -single component from fermented。

 

  "Biochemical Drug GMP Appendix" will refer to the organ of the biochemical drug、Organization、body fluid、Previous treatment in the secretion、Extraction、Separation、Purification and other safety、Effective、Drugs with controllable quality;、The product of the urine also executes it according to the appendix。once again emphasized the attributes of the medicine & mdash; & mdash; & ldquo; safety、Effective、Quality controlled & rdquo;。

 

  Based on this notification，Biochemical drugs mainly include: protein、polypeptide、amino acid and its derivatives、polysaccharides、nucleotide and its derivatives、fat、Enzymes and Coenzymes (excluding products listed in Appendix of Biological Products)。

 

  Combined to market status quo，You can see，Biochemical drugs with larger sales of hospitals are thymptophyll peptide、Mavericks blood de -protein extract、thymus peptide、Encephaloside and composite coenzymes，It is mainly clinically applied with neurological protective agents and immune enhancers。This type of product's composition structure is not clear，The efficacy is not clearly defined as & ldquo; auxiliary medication & rdquo;，It is also included in & ldquo; key monitoring drug directory & rdquo;。The current medical insurance directory adjustment policy is negatively negative，Medical insurance payment policy tends to strictly control the use of such drugs。

 

  Overall，Sales growth of such varieties is facing pressure，Now CFDA releases biochemical drugs GMP appendix strict supervision，will increase corporate costs，Accelerate the elimination of biochemical drug companies。

 

  Cost increased to accelerate the elimination of biochemical drug companies

 

  2015 CFDA has tracked and checked thymptopptide stake betting appproduct companies。The reason is: the source of the thymus is not clear，Insufficient suppliers of thymus gland，Production system virus activation process verification does not target key process parameters，Quality Control System Internal Control Standard Lack of Internal Control Standard。

 

  Biochemical Drug GMP Appendix is ​​particularly in supply chain management、Factory and equipment、Virus removal/activation and verification and other chapters detailed execution regulations hard requires enterprises to improve quality management。& ldquo; supply chain management & rdquo; Article 27 & ldquo; supplier administration & rdquo; medium，It is clear that the quality management department shall establish a supplier quality management file according to the characteristics of the variety，and also follow the 28th & ldquo; supplier audit & rdquo; regularly conduct on -site audit on raw material suppliers。

 

   & ldquo; Article 15 of the factory and equipment & rdquo;，& ldquo; There should be a dedicated area in front of raw materials，Raw materials (raw solution) preparation and preparation production area should be strictly separated。The air -conditioning purification system for preparation and preparation production of raw materials (raw liquid) should be set independently & rdquo;。Biochemical Drug GMP Appendix has not been the GMP requirements like the Chinese patent medicine & rdquo;，For the Chinese Medicine Extract & RDQUO; Chinese Medicine GMP Certificate in Traditional Chinese Medicine will indicate the aspect of & ldquo;。

 

   & ldquo; Virus removal/activation and verification & rdquo; The session has as early as the "Notice on the Basic Technical Requirements to the Publishing Basic Technical Requirements for the release of the basic technical requirements for the release of chemicals and multiple groups。New regulations for GMP Appendix My stake betting appof Biochemical Drugs Clarify the virus challenge test in the verification of virus removal/activation methods.，This means that the company needs to use the simulation process conditions that are closest to the actual production process (appropriately reduced) for process verification。

 

  Verified effective process steps Its process parameters (temperature、Time、Membrane model and specifications、types and concentrations of activists) and other conditions during product verification (pH、ion concentration、protein concentration、Protective agent types and concentrations, etc.) In the actual production process, it must not be changed，It must be maintained within the scope of the license determined during verification。If it exceeds the original limited range，Need to be re -verified。Once this policy is approved，For biochemical companies that have not established & ldquo; virus removal/survival and verification & rdquo; key process parameters, I am afraid to stop production for a period of time。

 

  Quality management must be based on the quality standards approved by the People's Republic of China and the national drug supervision and management department.、Accessories、Middle Product、Raw materials (raw solution) and finished products for inspection。Unable to determine the standard，Enterprises should establish suitable internal control quality standards in accordance with the quality risk of variety。This rule is for corporate products such as thymptopptide and sodium heparin，or a strict internal control quality standard system is favorable。

 

  Biochemical Drug GMP Appendix Promoting the Quality Control of Biochemical Drugs adopts biological analysis technology，The author believes that the highest cost lies in the identification of animal species of raw materials (such as the PCR method, etc.)，For companies, stake sports betting appsupporting instruments and quality analysts require relatively high。

 

  Conclusion

 

  Issuing of GMP Appendix of Biochemical Drugs，The production of biochemical drug companies will be regulated，It is beneficial to the health of the people。But for most biochemical drug manufacturers，The introduction of this rule will accelerate the survival of the industry in the industry，Only companies with hardware and management software can obtain vouchers in the future market。