New GMP brings the risk management of quality into schedule

New GMP brings the risk management of quality into schedule
"China new GMP propose the intersection of quality and basic demand of risk management, define enterprise must whole lifespan in medicines carry on the assessment according to scientific knowledge and experience, and is concerned with with the goal of protecting the patient finally, in the risk management of quality, enterprise's diligent intensity, form and file should accommodate rank of the risk. " National food medicines supervision bureau (SFDA) Medicines supervise department, produce, supervise Qing Guo, division chief of office, five express at January 10 2010 the intersection of medicine and quality and competitiveness International studies global that hold safely.
It is not a fresh concept
Reporter of " economic newspaper of medicine " knows: New revision of GMP finish to solicit behind the opinion the second round, at present already draft sent for examination, draft, prove, send Policy and Regulations Department to, go on, verify with relevant the intersection of background and material.
"According to requirement of WHO, we contrast the situation with WHO medicines GMP, notify the intersection of medicines and GMP that revise to WHO, WHO shows clearly, GMP standard that the GMP standard and other regulations of medicines GMP level and WHO revised supervise the strict country is compatible in feedbacking the opinion. " Guo Qing five reveals.
It is unfresh that product quality reviews the concept increased newly this time in analysis, quality licensor, quality risk management,etc.. In fact, FDA releases " cGMP in 21st century as far back as 2002 - -A method based on risk " ,Propose using the office procedure of the risk in pharmacy trade formally for the first time, but shortly after ICHQ9 was released in 2005, European Union adds risk management into regulation of its GMP.
Agent's vice director Edwin Rivera-Martiez of the intersection of the office and production and product quality department says that FDA CDER enforces the law: In the 21st century, cGMP has been already from paying close attention to the fact initially the mode appraised and developed is changed into modes that is implemented and realized, three major themes that cGMP works at present are: Encourage the method to evade on the basis of the risk, encourage producing the norm best, and promote and cooperate, improve the consistency and predictability.
Edwin Rivera-Martiez shows, FDA encourages GMP of all optimization to check the mode, for example carries on the choice of cGMP site of factory, guarantee the resources of FDA get the most effective use, in order to prevent the public health risk; FDA supports the risk management activity of industry, the efforts to include making in improving craft knowledge and risk control ability. Meanwhile, FDA will regulate the intensity supervised according to the risk level.
Still lack experience
Risk management is a lasting course, to medical trade, risk management researches and develops and begins to run through production to medicines, selling cycle from medicines. The purpose lies in through prospective risk assessment, and take the precautionary measures effectively, reduce the medicines quality risk to the greatest extent, thus protect a patient better. The quality of medicines especially demands to have safe, effective, economic characteristics.
It is reported, ICH Q9 proposes the procedure of risk management is: The risk assessment - risk control - risk communication - risk is evaluated. At risk assessment stage, should solve 3 problems, which may make mistakes (the risk is distinguished) What it is in probability on, make mistakes ' Namely risk analysis) , wrong and severe ' Namely appraisal of risk) ; In the intersection of risk control and stage, solve two problem emphatically, namely with what way come on, reduce or dispel risk (risk reduce) , risk after lowering up to acceptable competence ' The risk accepts) ; During the course of communicating in risk, Q9 demands to share the information of risk management, promotes trust and understanding. Record the output result of risk management finally, will evaluate in order to finish the risk.
|