【直报网1月27日讯】（新康界）纵观几家欧盟GMP检查失败的缺陷项清单，硬件部分几乎没有，主要缺陷在于软件部分。

CNDSN January 27th news (Xinkang circles) defect list throughout several EU GMP check failed, the hardware part almost no, mainly lies in the deficiency of software.

近期，多家中国药企欧盟GMP检查失败，在国内制药行业引起极大震动，包括台山市化学制药有限公司、浙江普洛康裕生物制药有限公司、福建南方制药股份有限公司……尤其是华北制药的“沦陷”，在蒲公英制药技术论坛引起了广泛的讨论，尤其发人深省。

Recently, several Chinese pharmaceutical companies for the EU GMP inspection failure, caused great shock in the domestic pharmaceutical industry, including Taishan City Chemical Pharmaceutical Co. Ltd, Zhejiang Apeloa Biological Pharmaceutical Co. Ltd, Fujian Nanfang pharmaceutical Limited by Share Ltd...... Especially in North China Pharmaceutical "fall", caused widespread discussion in the dandelion Pharmaceutical Technology Forum, particularly revealing.

“看来是越来越严格了！”“国内药企多年积累的恶习暴露于天下”“严重缺陷都是数据、记录不真实，华药是中国药企的缩影啊！”“国内企业都是这样的，中国制药整体氛围就是造假，没有哪个能经得起再查”“大环境的问题，需要从根上肃清。”“数据造假FDA都是不能忍受的，其实国内检查也一样”，甚至有人提出“药监部门应该联动，凡是国际检查被枪毙的，国内的GMP证书也应当吊销。他山之石，可以攻玉。”

"It seems to be more and more strict!" "The accumulation of domestic pharmaceutical enterprises for many years of exposure to the world" vices "serious deficiencies are the data, records are not true, Chinese medicine is a microcosm of China Pharma ah!" "Domestic enterprises are like this, China pharmaceutical integral atmosphere is false, no one can withstand check" "environment, need from Nenoue Shi." "The data fraud FDA can't stand, in fact, domestic inspection is the same", even someone put forward "the drug administration department should linkage, all international inspection be shot, domestic GMP certificate shall be revoked. Outside the Box, jade."

纵观几家欧盟GMP检查失败药企的缺陷项清单，硬件部分几乎没有，主要缺陷在于软件部分：数据管理不充分、数据不准确，分析报告造假，记录更换内容、重抄记录、多处日期和签名不一致。QC实验室电子数据安全性、完整性不足，没有权限控制，没有审计追踪，没有删除数据的限制等。质量管理体系缺陷，数据审核、文件管理、偏差处理等方面。包括计算机验证、计算机管理方面。

The defect list throughout several EU GMP check failed practices, the hardware part almost no, mainly lies in the deficiency of software components: data management is not sufficient, inaccurate data, analysis report fraud, record of changing content, re copying records, many date and signature is not consistent. Deficiency of QC Laboratory of electronic data security, integrity, no access control, no audit trail, no delete data limitations etc.. Quality management system defects, data verification, file management, deviation handling etc.. Including computer validation, computer management.

实施新版GMP认证以来，也有人作过统计分析，在发现的缺陷中，厂房设施等硬件缺陷不足15%，质量体系、文件管理、验证管理、机构人员超过55%，生产管理、设备管理等其它方面占30%。

Since the implementation of the new version of GMP certification, also some people made a statistical analysis, the defects found in plant facilities, the defects of the 15%, quality system, file management, validation management, agency personnel more than 55%, production management, equipment management and other aspects accounted for 30%.

由此，我想到了以前大家一直都在批驳的一个观点：“硬件不足软件补”，我不知道现在“软件不足什么补？”“管理不足什么补？”

Therefore, I think before we are always in a point of criticism: "Premium software", now I don't know "what software is insufficient to fill?" "Management issues what fill?"

一单眼皮美女去拉了双眼皮，这叫做“硬件不足硬件补”，锦上添花。

A single edged eyelid beauty to pull the eyelid, which is called "the lack of hardware hardware fill" icing on the cake.

一唇裂儿童去做了唇裂修复，这叫做“硬件不足硬件补”，雪中送炭。

A cleft children to do cleft lip repair, which is called "the lack of hardware hardware fill" timely help.

老掉牙的XP电脑想运行win8，只能精简和优化系统，这叫做“硬件不足软件补”。

Old XP computer to run win8, only to streamline and optimize the system, which is called "premium software".

拥堵城市“限购、限行、单双号”，这叫做“硬件不足软件补”。

Jam "City purchase limit, limit line, single", this is called "premium software".

总之，很多先天缺陷、暂时无法解决、又不足以有致命风险、或者解决成本太高、性价比太低，依靠“优化工作流程、完善操作SOP”等措施可以将风险降低在可接受范围内，何乐而不为呢？

In short, a lot of congenital defects, temporarily unable to resolve, but not enough to have a fatal risk, or solve the cost is too high and the price is too low, relying on the "optimize work process, improve the operation of SOP" and other measures can reduce the risk in acceptable range, so why not?

试想，如果一个截肢患者家里没钱，他会去装假肢吗？如果一个女人家里没钱，她会去韩国整容吗？如果一个有钱人，他还会用老掉牙的电脑安装精简系统吗？如果一个城市的规划合理、交通发达，还需要限购、限行吗？

Just imagine, if an amputee family had no money, he will go to the prosthetic? If a woman no money at home, she will go to Korea to have plastic surgery? If a rich man, and he will use old computers installed streamlined system? If a city planning reasonable, traffic developed, also need to purchase limit, limit line?

在制药行业，在GMP实施过程中，绝大部分人非常反感“硬件不足软件补”这句话，他们认为这句话本身就是企业不想加大“硬件”投入、或者工程实施阶段没有做好“硬件”、又非常不愿意进行硬件整改的借口。

In the pharmaceutical industry, in the process of GMP implementation, the vast majority of people are very disgusted "Premium software" this word, they think this sentence itself is the company does not want to increase the "hardware" input, or the project implementation stage did not do a good job in the "hardware", but also very reluctant to hardware rectification excuse.

事实上，目前国内的GMP实施水平在硬件方面已经有了很大的提高，虽然我国的制药装备创新能力不强，行业整体技术水平不高，低水平的模仿泛滥，集成化、自动化水平有待加强，但是随着制药装备行业的多次洗牌，部分药机龙头企业的优质资产整合、部分药机企业的专业化水平提升，除了部分经济条件较差的药企选择质低价廉的药机装备外，我国的制药装备水平已经完全能够跟得上药企GMP水平的整体步伐，反而是药企的GMP理念、软件文件、质量管理……等方面的落后，造成了药企GMP合规性和药品质量的严重风险。

In fact, the current domestic GMP implementation level in terms of hardware has been greatly improved, although the equipment innovation ability of pharmaceutical in China is not strong, industry overall technical level is not high, the low level of imitation overflowed, integration, automation level need to be strengthened, but as the pharmaceutical equipment industry repeatedly reshuffle, some medicine machine tap enterprise integration of high-quality assets, some medicine machine enterprises professional level, except the part of poor economic conditions of the pharmaceutical companies choose medicine machine equipment quality low, the level of pharmaceutical equipment in our country has been fully able to follow the pace of the whole pharmaceutical GMP levels, but is the industry the concept of GMP, software documentation, quality management...... Aspects of the backward, causing a serious risk of pharmaceutical GMP compliance and drug quality.

很多药企，厂房设施建设、设备选型，可以说都是国内一流、甚至国际一流的，但是由于GMP理念、质量管理意识的落后，形成了二流的软件文件、二流的质量管理体系，好不容易有些药企花费重金移植了一套一流的软件文件，也仅仅是为了应付一时的GMP检查，拿到证书，万事大吉，或者迫于人员素质、管理水平、成本压力……将一流的软件束之高阁，依然我行我素地重复着三流的管理水平。

Many pharmaceutical companies, facility construction, equipment selection, can say is the domestic first-class, and even international first-class, but due to the GMP concept, the consciousness of quality management is backward, the formation of software documentation, the second of the second of the quality management system, finally some pharmaceutical companies spend heavy gold to transplant a first-class software files only in order to cope with a GMP check, get certificate, fine, or because of the quality of personnel, management level, cost pressure...... Will be first-class software on the shelf, still go its own way to repeat the three flow management level.

“一流的硬件、二流的软件、三流的管理”，这可能才是多家药企欧盟GMP检查失败的根本原因，这其中的某些缺陷，在国内的GMP检查中也应该比比皆是，也有可能是中外GMP检查的差异和检查员审美观的不同，耳闻目睹，轻重不一。

"First-class hardware, the second of the software, the flow of the three management", this may is the fundamental reason for many companies of EU GMP check failed, some defects which, in the domestic GMP examination should also meet the eye everywhere, there may be differences between Chinese and foreign GMP inspection and inspector of aesthetic is different, what one sees and hears, do not weigh the same.

“一流的硬件、二流的软件、三流的管理”，背后深层次的原因，更值得大家去发现和解读！▲

"First-class hardware, the second of the software, the flow of the three management", the deep-seated reasons behind, more worth to find and interpret! *

(original title: many companies have been "occupied" EU GMP inspection defects where?)

责任编辑：宝蓝

Editor: Blue