Quality Thinking in other Industries. Dominic Parry Inspired Pharma Training. WEB GMP BLOG inspiredpharmablog.

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1 Quality Thinking in other Industries Dominic Parry Inspired Pharma Training WEB GMP BLOG inspiredpharmablog.com

2 Welcome The traditional focus on quality Quality in the eyes of GMP What does Quality mean today? Quality in other industries The evolution of GMP Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 2

3 The aim of GMP The aim of GMP is to get safe and effective product of the right quality to the patient Important to have GMP because of the risks of getting it wrong GMP has a fantastic track record when used properly Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 3

4 What is GMP? Product quality standard Single customer patient GMP and the inspection process Many positives too! Single agreed standard across Europe Inspection by one Regulatory Authority Similar principles adopted around the world In many ways still ahead of other sectors Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 4

5 Pharmaceutical quality thinking Whilst GMP has many positives it is not without its deficiencies! In some areas it stood still for many decades allowing many other sectors to catch-up and overtake when it comes to modern QMS thinking Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 5

6 So what s wrong with GMP? Let s not forget GMP has many positives! But it is not a Quality Management System (QMS) It is PART of your QMS, but not a QMS in its own right Quality Assurance therefore incorporates Good Manufacturing Practice plus other factors outside the scope of this Guide EU GMP Chapter 1 Can encourage the status-quo Has little incentive to change and improve Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 6

7 GMP and Quality Early editions of GMP in the 1970s had a Quality Control focus and a QC Department The 1970s and early 1980s was the QC era for all leading industries QC is still defined in GMP as: Sample Test / Check / Inspect Pass or reject EU GMP Chapter 1 Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 7

8 1980s and early 1990s The Qualified Person (QP) arrived in GMP QPs duties simply added to existing GMP The notion of Quality Assurance arrived It became a requirement of GMP to have a QA system No clear guidance on what the system should include No additional requirements added for the QA Department or QA Manager Still no mention of QA Department or Manager in the 9 Chapters or Annexes of EU GMP At this time other leading sectors where introducing the notion of QA, whilst GMP gave no formal requirement on really what QA was Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 8

9 QA within GMP Whilst there is still no formal requirement for a QA Department, there are many QA elements within GMP Training Documentation and records Supplier approval Validation Planned preventative maintenance Internal audit / self-inspection Control of deviations, complaints and recalls Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 9

10 The Chapters of EU GMP 1. Quality Management 2. Personnel 3. Premises & Equipment 4. Documentation 5. Production 6. Quality Control 7. Contracting out 8. Complaints & Recall 9. Self Inspection Plus Annexes Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 10

11 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 11

12 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales DIRECTLY covered by GMP Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 12

13 The Chapters of EU GMP Core activities 5. Production 6. Quality Control Support activities 1. Quality Management 2. Personnel 3. Premises & Equipment 4. Documentation 7. Contracting out 8. Complaints & Recall 9. Self Inspection Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 13

14 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales LIMITED coverage by GMP Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 14

15 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales NO coverage by GMP Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 15

16 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 16

17 The pharmaceutical company Site Head Prod QC Engineers IT R&D HR Planning Finance Purchasing Sales All of these departments can impact on Product Quality and Level of Service Organisation s today needs a QMS that is aligned with the needs of all parts of the business Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 17

18 Quality in the early 1990s In 1994 a new Quality Management Standard arrived: ISO 9000 : 1994 Generic standard for Quality Management Was looked at by pharma and was generally disregarded Could be of value for suppliers Lacked the depth of product quality focus that already existed within GMP Did focus on the whole of the organisation, rather than part of the organisation Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 18

19 Late 1990s ISO 9000 was in real trouble People didn t like its focus on simply having a procedure for everything Industry didn t think it reflected their current needs No real mention of: Processes Avoidance rather than checking Prevention rather than rejection The role of Top Management Considering the needs of all customers Continual improvement Being effective and efficient Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 19

20 Why was this important? Other industries were under increasing pressure to: Reduce waste and duplication Be more competitive Think beyond just product quality Reduce lead-times Deliver on time and in full Consider the needs of all stakeholders Be more ethical and consider environmental impacts Be able to react to changing circumstances Provide a product/ service that the consumer actually wanted Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 20

21 Pharma? In may ways buffered from economic pressures It was only in the 1990s that large sites started to close Continued into 2000 and beyond With mergers of organisations AND the growth of the emerging markets COMPETITION has arrived in Pharma One site is compared to another in many ways Hence the need for sites to evolve Hence the need for our system to evolve Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 21

22 Our system (GMP) Traditionally we have focused on Product Quality GMP does this. Its focus is Production and QC But there are other importance factors to consider in addition: Batches made on time and in full Are available where and when needed The needs of all customers (internal and external) Increased efficiency Continual improvement in all areas We ignore these factors at our peril if we are to be competitive as an industry, organisation or site Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 22

23 2000 and beyond ISO 9000 evolved Much bigger role for Top Management QMS linked with business needs and goals QMS covering the whole business Focus on Continual Improvement and Customer Focus Focus on all processes within an organisation together with their interaction Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 23

24 Processes typical example Finance Management review Communication Documentation Engineering Validation Internal audit SUPPORT PROCESSES Sales and marketing Planning Purchasing Warehouse QC Production QC Warehouse Despatch CORE PROCESSES Engineering QA Training Premises and equipment Corrective action Preventive action Continual improvement SUPPORT PROCESSES Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 24

25 Other industries - processes Processes Mapped all processes that can impact on product quality and level of service Identified the supplier and customer of each process Established what the customer wanted Considered what the process needed to achieve Set objectives and key performance indicators for these Not just production s processes but all processes in the whole organisation Needs to be seen as part of the QMS Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 25

26 Processes Process performance is monitored and measured Displayed visually Notice boards / Visual Boards Data on processes analysed Opportunities for improvement highlighted, reviewed and actioned Many data gathering techniques are available Processes reviewed to identify areas of risk Many risk management tools are available Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 26

27 Other industries - avoidance Avoidance rather than checking Having greater confidence in what is delivered to you in the first place Remember we have a heavy QC mentality QC in our world is flawed, as it relies on destructive sampling Other industries have partner with suppliers (procurement excellence) whereby materials are delivered and used with no QC tests performed by the purchaser Unlikely to every be normal practice in pharma Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 27

28 Other industries - prevention Prevention rather than rejection Having mechanisms to deliver pro-active risk assessments Programmes in place to perform risk assessments on all lines, equipment, items and processes Focus is not just on risk to the patient. Considers: Risk to product quality Risk to operators Risk to the environment Risk to the business Looking for areas of waste, duplication and over-working Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 28

29 Other industries Top Management The role of Top Management No longer is the QA system owned by the QA Manager The QA system is part of the business The QA system is the business Top Management it s YOUR system They have the money, the influence, the resources and the responsibility to influence, change and improve Top Management need to demonstrate a clear vision and strategy for the QMS and commitment necessary resources to achieve its objectives Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 29

30 Other industries - Management Review Top Managers will regularly review their system Many times a year during Management Review INPUTS Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous reviews Changes Recommendations for improvement Designed to be a proactive fora rather than a reactive one OUTPUTS Improvement of the effectiveness QMS and its processes Improvement of product related to customer requirements Resource needs Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 30

31 Management review Plus Top Management will visit all parts of the organisation on some form of schedule Perhaps once a week or once a month Actively participating in departmental reviews around the organisation Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 31

32 Other industries - Customers Other industries have recognised that there are a range of customers with varying needs Most do want product of the right quality! NB the only customer of GMP is the patient External customer Wants orders to be considered and evaluated before acceptance Wants to be told if there is a problem Wants to be told if an order will be late May be worth asking for feedback before complaints Wants to see improvements Or may take business elsewhere! Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 32

33 Other industries - Customers Other industries have recognised that we need to think about the internal customer Organisations are full of internal customers NB not mentioned in GMP Internal customer and the individual Wants good two-way communication to take place Wants their ideas listen to Need objectives and appraisals Wants to be told if something will not arrived as agreed Doesn t want to send things back because there is something wrong Doesn t want to chase for things that haven t arrive Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 33

34 Other industries - Continual improvement Everyone says that they continually improve but when and how? GMP does provide a great focus on dealing with problems to they don t happen again GOOD but reactive NOT SO GOOD do we actually get to the root-cause of the problem all of the time? Not helped by having a one-size-fits-all approach to closing problems by a set day (say 30 days) Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 34

35 REAL Continual improvement Mechanisms that promote and drive continual improvements need to be in place Will always need to deal with problems Need systems for: Encouraging and rewarding improvement ideas Teams that will be tasked with making improvements Training 5S, Lean Sigma, Quality Circles, 7 wastes Need to be provided with objectives and measured against them Need to be actually making process improvements Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 35

36 Continual improvement of all processes Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 36

37 Other industries - Effective & efficient Most firms now have departmental boards Contains quality metrics on performance of key processes Daily meetings with key players occur Review recent events, successes, failures and plan for next few days, weeks and months ahead Normal practice in leading industries and is a great fora for dealing with corrections and corrective actions as well as looking at process performance Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 37

38 So what for GMP? Aren t we doing this already? Many of these ideas are in-place in organisations Many have been tried and not continued Organisations are now looking at these again and seeing how they can be used to add value Need to be done as part of the QMS not as separate to the QMS ICH Q10 and other quality documents have recently tried to take elements of ISO and put in a GMP context Looking at factors outside the scope of this guide ICH Q10 is not an easy to understand document Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 38

39 So what does this mean for QA today? Three strategies for change: ONE: Move from culture of checking and reaction to prevention and continual improvement Easier said than done but: Ensure corrective action really is corrective action Gather data to ensure problems have been dealt with to the root cause Look at data and suggest ideas for improvement Look at processes and design out areas of potential risk Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 39

40 So what does this mean for QA today? TWO Use your internal audit mechanism to look at all processes of the business and not just the GMP areas Focus on compliance as well as identifying opportunities for process and performance improvement THREE Don t use Management Review as a regulatory necessity Use it as a driver of the QMS and the business Use it to regularly review process performance and take action accordingly Use it to integrate quality initiatives Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 40

41 Why is this important? The evolution of QMS thinking started to occurred in other sectors nearly 2 decade ago Regulatory pressure is encouraging a more holistic view of quality Sites are under increasing pressure to be inspection ready AND be more efficient There are many sites that have closed often not because of poor GMP practices It is in all of our interest for sites to stay open and make quality medicines Better for jobs, the economy and is arguably a safer and shorter supply chain We need to embrace these ideas from other sectors Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 41

42 Thank you for listening Keep in touch with us. Blog: inspiredpharmablog.com LinkedIn: Dominic Parry Facebook: Inspiredpharma GMP, Pharmaceutical Lead Auditor, Quality Management and Qualified Person (QP) training Inspired Pharma Training 05/11/12 PQG Presentation 08/11/12 42