MHRA GDP Symposium Novotel London West, London. 4th December 2013

Transcription

1 MHRA GDP Symposium 2013 Novotel London West, London. 4th December 2013

2 Quality Risk Management An introduction. Steve Todd, Senior GDP Inspector

3 Contents Risk quotations QRM definitions ICH Q9 QRM in the new EU GDP Guide The risk assessment process Some risk assessment tools 3

4 Sage words Educated risks are the key to success. - William Olsten Living at risk is like jumping off the cliff and building your wings on the way down. - Ray Bradbury 4

5 More sage words Risk comes from not knowing what you re doing - Warren Buffett Take calculated risks. This is quite different from being rash. - George S Patton 5

6 Definitions (para 7 ICH Q9) Quality Risk Assessment - a systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards. 6

7 Definitions (ICHQ9) Quality Risk Management - a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle. Note: Risk communication promotes a culture of risk awareness. 7

8 QRM is not new.... but it s in the new EU GDP Guide. 1.1 Quality Management. Wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. All critical steps of the distribution process and significant changes should be justified and where relevant validated. 8

9 New EU GDP Guide 1.2 A risk based quality system. A change control system should be in place. This system should incorporate quality risk management principles and be proportionate and effective. Appropriate CAPA are taken to correct deviations and prevent them in line with the principles of quality risk management. 9

10 New GDP Guide 1.5 Quality Risk Management (refers to ICH Q9) Quality risk management should ensure that the evaluation of the risk to quality is based on scientific knowledge, experience with the process and ultimately, links to the protection of the patient. The level of effort, formality and documentation of the process should be commensurate with the level of risk. 10

11 New EU GDP Guide Equipment/qualification and validation. The scope and extent of such qualification and/or validation activities (such as storage, pick and pack processes) should be determined using a documented risk assessment approach. 11

12 New EU GDP Guide 6.3 Returned medicinal products. Returned products must be handled according to a written, risk based process taking into account the product concerned, any specific storage requirements and the time elapsed since the medicinal product was originally dispatched. 12

13 New EU GDP Guide 9.1 and 9.2 Transportation. Regardless of the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity. A risk based approach should be utilised when planning transportation. Risk assessment of delivery routes should be used to determine where temperature controls are required. 13

14 Risk Assessment process. Firstly, define the task The task can be defined and analysed by utilizing the knowledge and experience of relevant staff. A structured group discussion exercise can be an effective forum. Risk assessment does not need to be a complicated process and should be appropriate to your company. 14

15 Risk Assessment process. Life is really simple, but we insist on making it complicated - Confucius 15

16 Risk assessment tools. A simple spreadsheet method. Task = Transport Risk = Products delivered damaged by temperatures/impact on patient safety Action to mitigate = validate vehicles packing consignments seasonal variations driver training Control = Audit, monitor temperatures, training, SOPs Review = Not a one - off process 16

17 Risk assessment tools, some examples. The fishbone diagram (Ishikawa diagram) a simple and effective tool and works well in a group discussion. (Cause and effect) Flowcharts, process mapping. Failure Mode Effects Analysis. (FMEA) Evaluate the potential failure and then work on risk reduction. Rates and prioritises each risk. 17

18 Risk assessment tools, some examples. Hazard Analysis and Critical Control Points (HACCP) 1. Identify critical control points, (CCPs). 2. Establish the critical limits of the control, for example, the regulatory requirements. 3. Monitor the CCPs. 4. At which points in the process do potential hazards exist? 18

19 Risk assessment tools, some examples. 5. Corrective Actions. Fundamental to a Quality System, solves problems and ensures continual improvement. 6. Record keeping, a regulatory requirement. 7. Review as part of the self audit programme to ensure that HACCP is meeting regulatory requirements. 19

20 Risk assessment tools, reference; Quality Risk Management (ICH Q9) Annex 1 Risk Management methods and tools - fairly high level but a starting point. 20

21 Thank you. Steve Todd Senior GDP Inspector MHRA 151, Buckingham Palace Road London SW1W 9SZ Tel:

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23 MHRA GDP Symposium 2013 Novotel London West, London. 4 th December 2013