As of December 31 last year，my country has issued a new version of GMP certificate 802 cards，670 manufacturers involved in manufacturing enterprises; and at the end of November, only 597 companies received 699 new version of the GMP certificate。
 
Weng Xinyu, director of the production supervision department of the State Food and Drug Administration, revealed at a round table meeting held in Beijing on January 24th，The number of provinces will be announced every month。
 
According to an introduction，This is a measure to implement the new version of the drug GMP countdown work system in 2013，The National Bureau will also start investigating and analyzing the capacity of GMP certification enterprises，and supervise stake sports betting appand stake online sports bettinginspect the GMP certification inspection of various provincial bureaus。These measures are designed to accelerate the pace of implementation of the new version of GMP，Improve the quality of drug production。
 
Clearance: Reduce quality risk
 
Weng Xinyu said，2013，The National Bureau will also revise and improve the new version of the drug GMP related technical standards，One of the standards is the formulation and release of the "GMP certification risk assessment standard"。
 
Different from the 1998 version of GMP，The new version of the drug GMP specially emphasizes drug quality risk management。Evaluation of quality risks in the entire product life cycle of the medicine、Control、Communication、Audit，and adopt the method that is compatible with the level of risk、Measures。
 
Facts，In the previous SFDA certification center, it was found in the analysis of corporate defects that have been applied for but not passed the new GMP on -site inspection，The more common defects of the enterprise are precisely the lack of quality risk control。For example, the defects of facilities and facilities are mostly concentrated in the layout of the clean plant、The compliance of the predetermined use、Effectiveness of preventing confusion and cross -pollution、Warehousing area Warehousing conditions meet the sufficient quality requirements of materials and product quality; the defects of production management are mainly concentrated in preventing pollution and cross -pollution in production，Including materials My stake betting appused stake betting appduring production、Intermediate product、Sterilizer products、Management of unsightly products, etc.。
 
& ldquo;，Pharmaceutical Quality Risk, the more detailed the elements of each element，The easier it is to manage。& rdquo; One inspector said，It should take comprehensive and effective quality risk management measures through different categories，The quality risk of managers' quality risks of the pharmaceutical production lines and pharmaceutical production organizations is clear in the chest，Then take reasonable supporting drug quality risk management measures，minimize quality risk。
 
Review: Simplify program increase efficiency
 
The main body of the drug production is a pharmaceutical manufacturer，and the main body of GMP is also a pharmaceutical manufacturer。How to encourage enterprises，Give play to the enthusiasm of enterprises in improving the quality of medicines?
 
Weng Xinyu said，Recently, the "Notice on Accelerating the Implementation of New Revised Implementation of Newly revised Pharmaceutical Production Quality Management Standards for Promoting the Upgrade of the Medical Industry" issued by the four ministries and commissions of SFDA.、Establishing a survival fitness mechanism and other aspects have achieved breakthroughs，Its purpose is to encourage enterprises to play subjective energy。
 
Current，Many companies in my country have passed GMP certification from foreign advanced countries。For example，There are 6 preparation varieties; 223 phals of the PIC/S Stake Sports Bettingmember states GMP certified，There stake online sports bettingare 74 preparation varieties。And some companies pass through FDA、EDQM and other countries certification。
 
For these companies，Special regulations in the documents of the four ministries and commissions: & ldquo; For the company or other foundations of the GMP certification inspection of members who have passed the World Health Organization or Drug Inspection (PIC/S)、The quality assurance system is perfect、Enterprises that are not found in previous drug GMP certification inspections，Organizations and other measures through priority arrangements，Encourage all production lines to pass the certification at one time。For the production line of drug GMP certification inspection that has passed the World Health Organization or Drug Inspection (PIC/S)，The drug supervision and management department reviews its inspection work that it meets the requirements of my country's newly revised drug GMP，Can be directly passed for certification。& rdquo;
 
& ldquo; Review work is a kind of encouraging enterprises to go abroad、Promoting the reflection of the stronger enterprises to become bigger and stronger，At the same time, it will simplify the program to improve work efficiency。& rdquo; Weng Xinyu said，GMP review work will be checked on key factors such as the quality assurance system。
 
It is reported，To facilitate the unified standards and requirements of each province，The National Bureau will introduce a refined review work procedure and requirements in the near future。
 
Another，"Medical Oxygen and Chinese Medicine Drinking Stake Sports BettingPharmaceutical Stake Sports BettingGMP Appendix、"Parameter Shop Drug GMP Appendix"、"GMP Certificate Fill in Standards" and other related technical standards will also be drafted in 2013。