质量文化:历史教训


Posted by: David Churchward, Posted on: 28 February 2019 - Categories: Compliance mattersGood manufacturing practice

 

Senior management leadership and commitment of personnel at all levels (in other words, the organisation’s ‘quality culture’) are the foundation of measures that ensure product quality and continuity of supply. Although described in current guidance such as GMP Chapter 1 and ICH Q10, the importance of quality culture has been recognised for nearly half acentury.

高级管理人员的领导力与各级人员的使命感(换句话说,组织的“质量文化”)是确保药品质量和持续供应的基础。虽然质量文化在现行指南如GMP第一章和ICHQ10中才有阐述,但它的重要性在近半个世纪以来早已得到公认。


In 1972, a failure to sterilise a batch of intravenous fluid led to a public health emergency in the UK – often referred to as the ‘Devonport Incident’. The defective medicines were linked to fatalities and the Department of Health initiated what it called a ‘life ordeath’ search for unused product in the distribution network.

1972年,一批静脉注射液灭菌失败导致一起英国公众健康紧急事件通常称为“德文波特事件”。有缺陷的药品具有致命性,英国卫生部启动了被称为“生与死”的行动,寻找销售网络中尚未使用的药品。


In the days following the incident the Government commissioned C M Clothier to lead an inquiry into the circumstances leading tothe use of the contaminated fluids. It was a pivotal investigation in UK medicines history, which continues to influence international GMP requirements 47 years later.

事件发生后,政府任命C M Clothier牵头调查导致使用受污染液体的情况。这是英国药品史上一次非常关键的调查,它持续影响了后来47年的国际GMP要求。

(注:以上为19727Clothier的报告封面)

(导致在普利茅斯综合医院德文波特分部使用受污染灌洗液的环境包括生产环境调查委派组报告)

(主席 C.M.CLOTHIER, ESQ., Q.C., B.C.L., M.A.Oxon.

(根据女王旨意由社会事务大臣提交议会)

19727月)


The findings in the Clothier report we rewide-ranging, but several are of relevance to quality culture in 2019:

Clothier的报告中,讲到的问题非常多,但有几个是与2019年质量文化有关的:

  • “There was no imminent technological advance in the field of production of intravenous fluids which will eliminate the need for skillful people devoted to their work”

  • 在静脉注射液生产领域,没有什么先进技术可以取代为工作奉献且对工作熟练

    的人员

  • there was “a belief that sterilisation of fluids is easily achieved with simple plant operated by people of little skill under a minimum of supervision, a view of the task which is wrong in every respect”

  • 有一种思想认为液体灭菌只要有简单的工厂,让稍有技能的人在最低的监管下

    操作就可以很容易地达成,这种想法不管从哪个方面来说都是错误的

  • “Public safety ….. depends ultimately on untiring vigilance both in industry and by government”

  • 公众安全……最终依赖于企业和政府长期不懈的警醒守护

The warning was clear: regulations, GMP and inspections alone could not guarantee prevention of similar disasters. Sadly, there have been other examples globally since the 1970s.

历史的警告是明白无误的:并不能仅靠法规、GMP和检查来保证不会发生类似灾难。令人痛心的是,70年代以来,还有其它的全球性事件发生。

Indicators 指标

Despite long-term awareness of its importance, it remains difficult to define and measure ‘quality culture’. MHRA inspectors look for indicators showing that personnel at all levels of the organisation have appropriate technical knowledge to enable good decision-making and understand how their actions impact the product and patient.

虽然早就知道“质量文化”的重要性,但仍很难对它进行定义和测量。MHRA检查员寻找证据证明公司内各层级人员均具备恰当的技术知识,有能力做出良好决策,理解他们的行为会对药品和患者产生何种影响。

A strong quality culture is built upon: 强大的质量文化是基于:

  • knowledge of what is important, and how a process achieves critical quality attributes

  • 知识:知道什么重要,一个工艺如何获得关键质量属性

  • diligence, by fostering awareness that everyone contributes to product quality, and understanding that “my actions impact the patient and the company”

  • 尽责:通过培养每个人都对药品质量作出贡献,了解“我的行为会影响患者和公司”的质量意识来实现

  • vigilance by individuals who know what ‘right’ and ‘wrong’ look like in their process, and a mechanism for management to be aware of problems

  • 警惕:个人知晓其工作中对错情形,有机制让管理层看到问题

  • senior management commitment to being visible and transparent in decision-making so that positive outcomes can be seen from the diligence and vigilance efforts. This is more than the company mission statement – it’s ‘walking the talk’.

  • 高管承诺:承诺决策过程透明可见,员工能看到尽责与警惕工作获得好的结果,这比公司使命声明更为重要---这是“走动谈话”

Global diversity 全球多样化

Pharmaceuticals utilise an increasingly global manufacturing supply chain. Common approaches to organisational behaviour may not always be effective due to societal considerations and there are many different influences on quality culture. We should be prepared to accept that an effective quality culture in one region may look different to that in another.

药品使用了全球日益增长的生产供应链,公司行为常用方式可能因为社会原因而并不总能保持高效,这对质量文化有许多不同影响。不同地区其有效的质量文化可能与另一地区是不一样的,对此我们要有所准备。

By being sensitive to the influence of global culture on organisational behaviour, we gain insight into the effectiveness of the ‘vigilance’ part of the quality culture, which can influence the selection of metrics. What matters is that the desired outcomes are achieved.

通过保持全球文化对公司行为影响的敏感度,我们能看到质量文化中“警惕”部分的有效性,它可能会影响对量度的选择,而最重要的应该是获得所要结果。

Quality culture – facilitating desired behaviours

 质量文化便于达成行为目标

Enabling a good quality culture requires continued effort from leadership and empowerment at all levels of the organisation. It is facilitated by clear communication of priorities:

形成优良的质量文化需要公司各级领导的持续努力,为此贡献力量。对优先事项进行明确的沟通会有所帮助:

  • to personnel, helping them to understand the importance of their work

  • 对于个人来说,有助于他们了解其工作的重要性

  • to shareholders, to avoid unrealistic productivity pressures and explain the business and reputational benefits that a positive quality culture can realise

  • 对于股东来说,避免不现实的收益压力,解释好的质量文化可以实现业务收益并收获好的声誉

  • to supply chain partners, making clear the information and resource requirements required for a consistent supply of high quality product

  • 对于供应链伙伴来说,给出明确的信息,要求持续供应高质量药品

Communicating priorities to regulators can also influence the company’s risk profile, and for organisations who consistently demonstrate good quality-focused decision-making, the possibility of achieving regulatory relief as a result.

优先与监管方沟通亦可影响公司的风险概况,让公司持续证明其关注质量的优秀决策行为,从而具有达成法规理念的可能性。

Back to 1972 ...

回首1972

In today’s computerised, high-tech pharmaceutical environment, it is worth reflecting on the Clothier report conclusions from 47 years ago.

在今天的高科技计算机化药品环境中,47年前Clothier的报告结论值得反思。

Technology in 2019 continues to progress at an incredible pace in new product development and novel manufacturing, an alyticaland supply chain practices. Some of these may require new regulatory approaches, which I will describe in a future blog post.

2019年的技术使得新药研发和创新生产、分析和供应商规范继续以不可思议的速度前进。其中有些可能需要新的法规方法,在后续的博客中我会再讲这个问题。

Despite significant progress in automation, there is still no replacement for a skilled and dedicated workforce who understand the importance of their work. Industry and regulators must maintain the highest levels of quality culture vigilance. I wish you success with these efforts as we go forward in 2019.

虽然在自动化方面我们取得了重大进展,但仍无法取代一些了解其工作重要性的技术和专业人员。企业和监管机构必须维护最高水平的质量文化警觉性。希望我们在迈向2019年时大家在这些方面取得成功。