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Traditional GMP and modern QMS thinking
- 1. Chapter 7 Traditional GMP and modern QMS thinking Title slide
- 2. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 2 Quality Assurance in GMP • GMP’s stance on Quality Management is presently evolving • Evolutionary journey • What GMP has said up until the last year or so
- 3. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 3 Quality Assurance in GMP • Article 6 – Quality Assurance System and Quality Management • Chapter 1 – Quality Management • Establish a QA System Article 6 Quality Assurance System The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different departments.
- 4. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 4 EU GMP Chapter 1 • Chapter 1 – How to establish an effective QA System that involves everyone – Sections • Principle • QA • GMP • QC • Product Quality Review – Rather than covering how to implement these elements or how to establish a QA system that involves everyone
- 5. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 5 EU GMP Chapter 1 Principle • Products are fit for use • Comply with registered requirements • Responsibility – Senior management – Commitment from staff at all levels • Comprehensively designed and implemented QMS • Fully documented and its effectiveness monitored • Adequately resourced with competent personnel • Suitable premises and equipment • PROBLEMS
- 6. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 6 EU GMP Chapter 1 Principle • Problems? – How to do any of this! – No further mention of Senior Management – No further mention of the commitment of staff at all levels – Without the commitment of Management and staff, few things ever happen well in an organisation!
- 7. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 7 QC, GMP and QA interrelationship QC GMP QA GMP includes QC QA includes GMP plus factors outside the scope of GMP
- 8. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 8 GMPs thinking of both QC and QA • Quality Control – Samples – Inspects / Tests and/or Checks – Passes or rejects – Narrow and reactive • Quality Assurance – Product of the right quality – Compliance with requirements – The patient • Defensive, reactive, mechanisms focused on maintaining the status quo
- 9. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 9 Evolution of both QC and QA • Quality Control – Investigate problems – Communicate – Trend data – Proactive • Quality Assurance – Beyond Production and QC – Performance of all processes – Needs of all customers – Proactive – Continual improvement
- 10. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 10 ISO 9000 – effectiveness & efficiency The extent to which planned activities are realised and planned results achieved Process operation The relationship between the result achieved and the resources used
- 11. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 11 In Summary • FDA report • A holistic notion of quality • Management principles • Continual improvement • Effectiveness and efficiency
- 12. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 12 Problems and concerns • Little guidance • Involvement of all personnel • Senior Management commitment • Narrow QC focus • QA stance • Efficiency of operation • Management principles • Continual improvement • Process approach • Contemporary quality thinking
- 13. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 13 Background to this evolution • Pharmaceutical industry was at one time one of the leaders in quality thinking – We will always need GMP – Product quality standard • No mention of: – All customers’ needs – Being efficient – Looking at processes – Continual improvement – Seen in isolation • Competition New challenges
- 14. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 14 Problems 1. A contract manufacturer has an on time delivery rate of 40%. In other words every month 60% of its orders are late to its customers. 2. A bottling line keeps breaking down due to the filler jamming. The product that leaves the line if perfect, but it takes twice as long to fill the product as it used to. 3. Staff working for an organisation have no appraisals and are given no feedback on their performance. 4. A site has been dumping a chemical in the local river killing lots of fish and other wildlife. They are about to face a heavy fine. 5. Incoming materials are not tested by QC for several weeks due to poor communication between the Warehouse and QC.
- 15. Inspired Pharma Training Ltd 10/06/13 Quality Management Systems 15 In summary • There is more to life than just producing product of the right quality • Effective – “an effective QA system” • Efficient • Continually improving • Cost, quality and delivery • Our system needs to evolve Customer Satisfaction Cost
Editor's Notes
- COMMENTARY: In earlier chapters we examined contemporary quality and Quality Management System thinking. Then we contextualised this and began to see the stance taken by the Pharmaceutical industry. We will now begin to see how the contemporary QMS thought process and the traditional pharmaceutical thought process marry up and so, welcome to this chapter on “Traditional GMP and modern QMS thinking”. YOUR NOTES:
- COMMENTARY: In this chapter we will look at what GMP has traditionally stated and expected with regard to Quality Management System (QMS) thinking and will consider how this compares to contemporary QMS thinking as employed throughout many other industries. At the outset it is important to acknowledge that GMP’s stance on Quality Management is presently evolving, something we will examine in detail in the next unit, but in the first instance we need to establish where we are coming from. In this way we can make sense of the current evolutionary journey, a necessary journey which some though regard with trepidation. And so when we use the word “traditional” we mean what GMP has said up until the last year or so. YOUR NOTES:
- COMMENTARY: The principle of Quality Assurance has always been a major part of GMP. This is easily demonstrated by the fact that the very first main article (Article 6) of both the Human and Veterinary GMP Directives (2003/ 94/ EC and 91/ 412/ EEC) is entitled Quality Assurance System and Quality Management respectively. This corresponds in both cases to the first chapter of the Guide to GMP (Chapter 1) on Quality Management. In other words GMP is stating that the first thing that you need to do if you are going to make medicines is to establish a QA System. This is confirmed in the contents of Article 6 (displayed on the slide) which makes it a legal requirement to have a QA System that involves everyone. Two things that you should note at this point with regard to the wording of this article. Firstly the use of the word “effective”, something we will come back to later on in the chapter. Secondly it states that the QA System should involve “the active participation of the management and personnel of the different departments”. In other words, the QA System should involve everyone. YOUR NOTES:
- COMMENTARY: Earlier in this course we showed how the chapters of GMP provide guidance on how a site working to GMP can achieve the requirements of the corresponding article of the GMP Directive. As a result EU GMP Chapter 1 should tell us how to establish an effective QA System that involves everyone. Unfortunately this chapter, despite starting well, has never really done this. In the ATTACHMENTS part of this presentation you will see the previous version of EU GMP Chapter 1 (Chapter 1 Quality Management OLD). Open up and/or print this document. It will be best to PAUSE the presentation whilst you do this. Looking briefly at the “old” or “traditional” version of Chapter 1 you can see that it consists of sections covering a Principle (we will look at this shortly) followed by sections on QA (at 1.2), GMP (at 1.3), QC (at 1.4), and Product Quality Review (at 1.5), elements of which we have already looked at. You may note that the chapter focuses more on what QA is all about, what GMP is all about and what QC is all about rather than covering how to implement these elements or how to establish a QA system that involves everyone. YOUR NOTES:
- COMMENTARY: The opening principle of (old) Chapter 1 is a long but sensible paragraph with some very important points. If you have not already done so read this now. It will be best to PAUSE the presentation whilst you do this. In essence this open paragraph states the following: The manufacturer must ensure that products are fit for use and comply with registered requirements. The responsibility for this rests with senior management and commitment from staff at all levels. There should be a comprehensively designed and implemented QMS, incorporating GMP. This should be fully documented and its effectiveness monitored. It should also be adequately resourced with competent personnel and suitable premises and equipment. Whilst I am sure that you are in no doubt about the importance of this statement, from a GMP point of view there are a couple of problems. YOUR NOTES:
- COMMENTARY: “What problems?” you may say. Well in the first instance the guide doesn’t actually tell you how to do any of this! The second problem is that within traditional GMP there is no further mention of Senior Management – neither in the rest of Chapter 1 nor in any subsequent chapters. Similarly, there is no further mention of the commitment of staff at all levels. This is not great because without the commitment of management and staff, few things ever happen well in an organisation! A few other problems also begin to surface with traditional GMP … YOUR NOTES:
- COMMENTARY: If we just think back to the previous chapter of this course we highlighted the inter-relationship of QC, GMP and QA and examined the associated traditional Quality-related definitions. It was stated that GMP includes QC … and QA includes GMP plus factors outside the scope of GMP. In itself this is a limitation of EU GMP. We are not told about these factors outside the scope of the GMP – a problem! What actually is QA? Please don’t say – a problem! YOUR NOTES:
- COMMENTARY: We have already looked in detail at Quality Control, and in the eyes of GMP it was seen as this - QC samples, then inspects/ tests and/ or checks and then either passes or rejects, and that appears to be the end of the story. If we compare this with QC’s role in contemporary Quality Management System thinking where it embraces process analysis, process performance, process management and the active promotion of continual improvement we see a rather narrow and reactive interpretation of this particular QMS element. We saw, in looking at Quality Assurance, that GMP’s thinking of QA has become a little outdated too. The traditional focus of QA has been on getting product of the right quality, compliance with requirements and thinking about the single customer of GMP, the patient. Whilst there is no argument that these still remain vitally important to the pharmaceutical industry, it is worth pointing out that Quality Assurance in other leading industries and in our contemporary thinking now looks at much more than this, embracing mechanisms for prevention and avoidance and again the active promotion of continual improvement – all elements omitted from this traditional approach. Both QC and QA are seen as rather defensive, reactive, mechanisms focused on maintaining the status quo, focused on being effective rather than, in addition, being actively involved in the promotion of improvement and greater efficiency of operation. YOUR NOTES:
- COMMENTARY: A modern Quality Control function will now do more that just sample, inspect and test. Today QC will investigate problems, communicate to other departments and suppliers in the event of problems, trend data to look for potential future problems and take proactive steps, rather than reactive steps, if data suggest action is needed. Likewise a modern Quality Assurance department will continue to focus on product quality, compliance and the needs of the patient. But also their role is evolving to align the quality system to areas beyond Production and QC, to look at the performance of all processes, to consider the needs of all customers (internal and external), to look at data and be proactive rather than reactive and drive continual improvement across the whole organisation. It is likely that your own QC and QA functions do some or all of the above but the point we are making here is this is not what GMP states that they need to be doing. If these concepts are adopted, both QC and QA would be seen as functions that enhance and improve a GMP-based Quality System. YOUR NOTES:
- COMMENTARY: We saw previously that Quality Management Systems have become less focused on effectiveness, the extent to which planned activities are realised and planned results achieved. This quite rightly the traditional domain of Pharmaceutical Quality Management System activity and absolutely necessary to ensure the manufacture and shipment of product of the right quality. But, in addition Quality Management Systems now need to also address the efficiency of operation where the relationship between the result achieved and the resources used is considered and so we engage the principles of process operation again, a feature not embraced by traditional GMP. YOUR NOTES:
- COMMENTARY: We pointed out earlier how the FDA had argued the limitations of GMP its findings in the FDA Report endorsing the need for a review of how the pharmaceutical industry viewed a Quality Management System and a change of mind-set was needed. A mind-set that sees a Quality Management System embracing a holistic notion of quality, that engages management principles, that acts as a catalyst for continual improvement of the system and its processes and that looks at both operational effectiveness and efficiency of the system and the processes that it embraces. And so, by the omission of these factors, traditional GMP and its approach raises a series of problems or concerns. YOUR NOTES:
- COMMENTARY: Traditionally GMP gives us little guidance on how to design and establish a suitable QA System nor does it tell us how we can engage or promote the active involvement of all personnel. Senior Management and Senior Management commitment receive only cursory attention and without this we are lost! Traditional GMP adopts a narrow QC focus and we also see a lack of depth in its QA stance. It says it incorporates things outside the scope of this guide but doesn’t tell us what these things are. Traditional GMP is simply not concerned with efficiency of operation, the engagement of management principles, or the promotion of continual improvement and its sole focus on the Production function does little to encourage the adoption of a process approach. Quite simply traditional GMP was out of step with contemporary quality thinking and over time the cry for it to evolve has increased. YOUR NOTES:
- COMMENTARY: Whilst it is generally recognised that the pharmaceutical industry was at one time one of the leaders in quality thinking it has, in many ways, stood still for decades whilst other sectors have overtaken it. This is not to say that GMP is either not needed or no good. We will always need GMP to help protect the end user from poor quality of medicines. Whilst traditional GMP has it strengths, then it also has its weaknesses. It is a great product quality standard, with a tradition and reputation to be proud of and generally it works. If you think about it the number of recalls and incidents of poorly manufactured medicines from reputable companies is very small. However, until recently, it has no mention of thinking about all customers’ needs, being efficient, looking at processes outside the Production process which may well impact on it and promoting continual improvement. These are principles that many other sectors started to look at decades ago. The system has been rather seen in isolation and not seen as an integral element of the business. As an industry we have not always needed to think of this because we have not faced the same financial pressures and competition that industries such as the automotive, aerospace, food and electronic sectors have faced. Until now that is. Now with competition between one site and another, the increase in generic manufacturing and competition from the emerging markets the industry faces new challenges. YOUR NOTES:
- COMMENTARY: Just dwell a pause for a moment and consider these scenarios (see the slide) – because, finally, there is the need to recognise that pharmaceutical manufacturing sites are businesses – and businesses need to survive and make money. Consider the scenarios on the slide. You should PAUSE the presentation. They all relate to pharmaceutical companies who make products to GMP. Have a look at these problems and ask yourself if are they breaking any existing GMP rules? Read these as they are and don’t try and read anything into them. YOUR NOTES:
- COMMENTARY: Hopefully you will have looked at these 5 situations and have realised that none of these impact on GMP or are GMP infringements. However, none of them are good and the organisations concerned could face real problems if they don’t sort these out. The reason why this is relevant is that we need to recognise that there is more to life than just producing product of the right quality. GMP takes care of this. Organisations today are recognising that they need to not only be effective – do what you say you will do, but also be efficient – use the resources well to achieve what you do. GMP focuses on being effective, for example - you need an effective QA system, but businesses need to be effective, efficient and continually improving in order to survive. This has resulted in a shift in QMS thinking in many sectors, linking the QMS with all of a business’ needs. GMP is now starting to catch up with this idea – but it still has a long way to go. Remember, generally items are purchased based on three parameters – cost, quality and delivery. GMP looks after one of these (quality) and now our system needs to evolve to embrace all of these elements. This is the final chapter in the opening unit of this course where we have covered the building-blocks of a Quality Management System. We have now given you sufficient background information so that we can move forwards. From the next unit onwards we start to explain how you design, implement, maintain, evaluate and improve a pharmaceutical Quality Management System. We hope you are enjoying the course so far if you have any problems or concerns please contact us. YOUR NOTES: