Food and Drug Administration to find the new GMP implementation will be guidance
Release time: 2012-02-29 & nbsp & nbsp & nbsp Source:
2010 version of GMP (hereinafter referred to as the new version of GMP) was launched for nearly 1 anniversary。To fully understand the implementation of the implementation of the new version of the GMP and existing problems，Accelerate the pace of transformation，February 16，National Food and Drug Administration (SFDA) issued the "Notice on the Implementation of the Pharmaceutical Enterprise Implementation of Newly Revised Drugs GMP, Investigation to Do a Better Classification Guidance" (hereinafter referred to as "Notice")，Requires all places to report back to May 1st，In the next stage, the corresponding classification guidance will be conducted accordingly。
Corporate pressure
"The system transformation of the enterprise from the beginning design to completion，To the end to pass the certification，The whole process basically takes one and a half to two years，Therefore，Time is already very urgent。"Ma Tao, deputy general manager of the GMP expert group, reminds。
"Currently adjusting software，Hardware reconstruction is still in design，It is expected to be completed in the first half of next year，The entire investment is about 30 million yuan。"Wang Yanfeng, the quality manager of Guangdong Bangmin Pharmaceutical Co., Ltd.stake online sports betting, Stake Sports Bettingsaid。It is understood，There are only 10 companies that officially obtain the new version of the GMP certificate.，Most companies are still in the initial design。So，Timely finding problems，Clear positioning，Narished and promoted the successful practice of advanced enterprises，It has become the top priority for many companies。
In the current implementation process，Enterprise and designer's understanding of the new version of GMP is still in the primary stage，The separation state presented in the design process is relatively obvious。"The design plan of many enterprises is still the reproduction of the 1998 version of GMP，The original intention of improving the overall management and technical level of enterprise through the new version of GMP。"" New version of GMP is one of the main drafting experts、The former deputy inspector of the Sichuan Food and Drug Administration Zhong Guangde said，The new version of GMP mainly has 4 major problems during the implementation process: First, the company will generally do not do URS design，Excessive dependence on the design institute; the second is to pin too much hope on the device manufacturer; the third is not good at organizing the elements of the quality system; the fourth is that the software system has not explored a new version of GMP requirements. Architecture。
URS is the basis for achieving the fundamental elements and risk management of the new version of GMP。For this，Many corporate representative suggestions，The principles of specifications or guidance in the field of pharmaceutical design should be introduced as soon as possible，Promote domestic designers to further understand the new version of GMP spirit，Promote the further unity of the designer and GMP certification personnel to understand and understand the new version of GMP，so。
In addition to some companies that have passed the EU GMP certification，There is a gap between the requirements of most sterile manufacturers and the new version of GMP。Ma Tao rough estimation，Including the air -conditioning system in the plant、filtering system、Test equipment and core equipment transformations stake sports betting appare stake sports betting appinside，The investment in a production line is not a decimal。So，Many companies are worried，The execution of the new version of GMP will increase the operating cost of the enterprise to a certain extent。
The representative of the "two sessions" is proposed，During the promotion of the transition period of the new version of GMP，Some encouragement policies or hard measures should be introduced，If you can give certain support in the national drug bidding purchase and drug pricing policy: For companies that have passed the new version of GMP，Give extra points when bidding for basic drugs，Give a single -column quality level in the bidding of non -basic drugs，Make the winning rate of drugs produced according to the new version of GMP standards; follow the principle of "high -quality and high prices"，Gives the difference in priority pricing; at the present stage of continuous price reduction in drugs，Appropriate reduction of domestic generic drugs produced according to the new version of GMP standard，To protect the enthusiasm of enterprise participation in certification。
In addition，Wang Yanfeng hopes that the country can give the new version of GMP technology transformation guidance fund support，or tax discounts such as pre -tax deductions for the new version of GMP technical reform，Relieve the capital needs of the enterprise，Avoid low -level duplication caused by the selection of equipment due to the dare not align with high standards。
and the implementation of the new version of GMP，The transformation and adjustment of enterprises in production has also begun to appear one after another，As a Guangdong Bangmin Pharmaceutical Factory，"The focus of the next step of the R & D and production of enterprises is likely to change to oral solid preparations。”
So，The investigation will be based on sterile medicine、Blood products and vaccine varieties、Classification survey of non -sterile drugs，Including a timetable for the enterprise scheduled to get the new version of the GMP certificate、Total capital investment required for certification、It is expected that the total number and reasons stake online sports bettingstake betting appfor the production line of the new version of the drug GMP can not be passed within the specified time limit、Plan to abandon the total number of production lines and reasons for the certification，and the available products and sexual impacts, etc.，The next step will be based on comprehensive guidance。
Talent shortcomings
"The new version of GMP is very particular about the play of the overall function of the team，and the phenomenon of talent shortage is currently prominent。"Zhong Guangde frankly。
On many talent recruitment websites and corporate homepages，You can see the information of the new version of the GMP project recruitment manager and related technical talents of pharmaceutical companies。The recruitment information of the new version of the GMP project transformation manager hung by a pharmaceutical company website in Hainan shows that the post requires a bachelor's degree or above in pharmacy or related majors; Require，Familiar with the GMP layout and construction requirements; participation or supervisor GMP project engineering manager preferred。At the same time，The company also recruits a large number of deputy managers of the Department of Quality Department、GMP Engineering Equipment Veritor、GMP certification commissioner and other talents，The lack of corporate technical reform talents has been fully manifested。
Talent shortcomings and incomplete understanding of the new version of GMP，The surge in the need for training needs。Current，Including SFDA Training Center、China Medical Equipment Engineering Association、China Medical Quality Management Association and other related associations，Is or planning to host a number of related training activities。
But solving the shortage of talents is not happened overnight，Ma Tao suggestion，Enterprises must focus on the cultivation of the production of front -line employees and the core backbone of the enterprise quality management，and strengthen the interaction between enterprises and related technical departments，in order to be within the transition period，Make the company's software stake online sports bettinglevel significantly improved overall。
In addition to the lack of corporate talents，GMP certification inspectors also have a large gap。At present, the professional level and inspection ability of the GMP certification inspector in my country is inconsistent，During the certification inspection process，There is also a certain difference in the interpretation of the clause，With the gradual implementation of the new version of GMP，Certified inspectors will face various practical problems from the scene，Some corporate representative suggestions，A group of representative problems should be concentrated at any time，Uniform solutions and authority explanations by experts，Avoid from person to person，The standard is inconsistent。At the same time，The scientific and reasonable pharmaceutical GMP inspector's appointment and evaluation mechanism should be established，GMP certification inspector is best to have more than 10 years of drug production enterprise production and quality management experience。(Author: Li Yuyin)
Corporate pressure
"The system transformation of the enterprise from the beginning design to completion，To the end to pass the certification，The whole process basically takes one and a half to two years，Therefore，Time is already very urgent。"Ma Tao, deputy general manager of the GMP expert group, reminds。
"Currently adjusting software，Hardware reconstruction is still in design，It is expected to be completed in the first half of next year，The entire investment is about 30 million yuan。"Wang Yanfeng, the quality manager of Guangdong Bangmin Pharmaceutical Co., Ltd.stake online sports betting, Stake Sports Bettingsaid。It is understood，There are only 10 companies that officially obtain the new version of the GMP certificate.，Most companies are still in the initial design。So，Timely finding problems，Clear positioning，Narished and promoted the successful practice of advanced enterprises，It has become the top priority for many companies。
In the current implementation process，Enterprise and designer's understanding of the new version of GMP is still in the primary stage，The separation state presented in the design process is relatively obvious。"The design plan of many enterprises is still the reproduction of the 1998 version of GMP，The original intention of improving the overall management and technical level of enterprise through the new version of GMP。"" New version of GMP is one of the main drafting experts、The former deputy inspector of the Sichuan Food and Drug Administration Zhong Guangde said，The new version of GMP mainly has 4 major problems during the implementation process: First, the company will generally do not do URS design，Excessive dependence on the design institute; the second is to pin too much hope on the device manufacturer; the third is not good at organizing the elements of the quality system; the fourth is that the software system has not explored a new version of GMP requirements. Architecture。
URS is the basis for achieving the fundamental elements and risk management of the new version of GMP。For this，Many corporate representative suggestions，The principles of specifications or guidance in the field of pharmaceutical design should be introduced as soon as possible，Promote domestic designers to further understand the new version of GMP spirit，Promote the further unity of the designer and GMP certification personnel to understand and understand the new version of GMP，so。
In addition to some companies that have passed the EU GMP certification，There is a gap between the requirements of most sterile manufacturers and the new version of GMP。Ma Tao rough estimation，Including the air -conditioning system in the plant、filtering system、Test equipment and core equipment transformations stake sports betting appare stake sports betting appinside，The investment in a production line is not a decimal。So，Many companies are worried，The execution of the new version of GMP will increase the operating cost of the enterprise to a certain extent。
The representative of the "two sessions" is proposed，During the promotion of the transition period of the new version of GMP，Some encouragement policies or hard measures should be introduced，If you can give certain support in the national drug bidding purchase and drug pricing policy: For companies that have passed the new version of GMP，Give extra points when bidding for basic drugs，Give a single -column quality level in the bidding of non -basic drugs，Make the winning rate of drugs produced according to the new version of GMP standards; follow the principle of "high -quality and high prices"，Gives the difference in priority pricing; at the present stage of continuous price reduction in drugs，Appropriate reduction of domestic generic drugs produced according to the new version of GMP standard，To protect the enthusiasm of enterprise participation in certification。
In addition，Wang Yanfeng hopes that the country can give the new version of GMP technology transformation guidance fund support，or tax discounts such as pre -tax deductions for the new version of GMP technical reform，Relieve the capital needs of the enterprise，Avoid low -level duplication caused by the selection of equipment due to the dare not align with high standards。
and the implementation of the new version of GMP，The transformation and adjustment of enterprises in production has also begun to appear one after another，As a Guangdong Bangmin Pharmaceutical Factory，"The focus of the next step of the R & D and production of enterprises is likely to change to oral solid preparations。”
So，The investigation will be based on sterile medicine、Blood products and vaccine varieties、Classification survey of non -sterile drugs，Including a timetable for the enterprise scheduled to get the new version of the GMP certificate、Total capital investment required for certification、It is expected that the total number and reasons stake online sports bettingstake betting appfor the production line of the new version of the drug GMP can not be passed within the specified time limit、Plan to abandon the total number of production lines and reasons for the certification，and the available products and sexual impacts, etc.，The next step will be based on comprehensive guidance。
Talent shortcomings
"The new version of GMP is very particular about the play of the overall function of the team，and the phenomenon of talent shortage is currently prominent。"Zhong Guangde frankly。
On many talent recruitment websites and corporate homepages，You can see the information of the new version of the GMP project recruitment manager and related technical talents of pharmaceutical companies。The recruitment information of the new version of the GMP project transformation manager hung by a pharmaceutical company website in Hainan shows that the post requires a bachelor's degree or above in pharmacy or related majors; Require，Familiar with the GMP layout and construction requirements; participation or supervisor GMP project engineering manager preferred。At the same time，The company also recruits a large number of deputy managers of the Department of Quality Department、GMP Engineering Equipment Veritor、GMP certification commissioner and other talents，The lack of corporate technical reform talents has been fully manifested。
Talent shortcomings and incomplete understanding of the new version of GMP，The surge in the need for training needs。Current，Including SFDA Training Center、China Medical Equipment Engineering Association、China Medical Quality Management Association and other related associations，Is or planning to host a number of related training activities。
But solving the shortage of talents is not happened overnight，Ma Tao suggestion，Enterprises must focus on the cultivation of the production of front -line employees and the core backbone of the enterprise quality management，and strengthen the interaction between enterprises and related technical departments，in order to be within the transition period，Make the company's software stake online sports bettinglevel significantly improved overall。
In addition to the lack of corporate talents，GMP certification inspectors also have a large gap。At present, the professional level and inspection ability of the GMP certification inspector in my country is inconsistent，During the certification inspection process，There is also a certain difference in the interpretation of the clause，With the gradual implementation of the new version of GMP，Certified inspectors will face various practical problems from the scene，Some corporate representative suggestions，A group of representative problems should be concentrated at any time，Uniform solutions and authority explanations by experts，Avoid from person to person，The standard is inconsistent。At the same time，The scientific and reasonable pharmaceutical GMP inspector's appointment and evaluation mechanism should be established，GMP certification inspector is best to have more than 10 years of drug production enterprise production and quality management experience。(Author: Li Yuyin)
