Quality Thinking in other Industries Dominic Parry Inspired - PowerPoint PPT Presentation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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