Quality Risk Management what s happening, the TGA and the how to

Transcription

1 Quality Risk Management what s happening, the TGA and the how to

2 Major changes to the GMP code Quality Risk Management Product quality review Ongoing stability program Manufacture of sterile medicines

3 GMP says

4 Annex 20 Quality Risk Management Adoption of *ICH Q9 - Quality Risk Management * The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

5 Annex 20 Quality Risk Management Assess risk Product lifecycle Review risk Control risk

6 Annex 20 Quality Risk Management Severity Opportunity Detection

7 Assessing risk What might go wrong? What is the likelihood it will go wrong? What are the consequences?

8 Identifying risk Sources of data may be more apparent than you think

9 Quantify and qualify risk Analyse risk

10 Evaluate risk Compare the risk to your pre-determined criteria

11 Control risk Mitigate eliminate Transfer Avoid Reduce

12 Accept risk...become comfortable with the fact that there is a limit to what companies can and will spend to avoid harm to patients. David Stokes, International Society of Pharmaceutical Engineering, Good Automated Manufacturing Practice Forum Member, 2006.

13 Sharing risk information Communication

14 Review risk Ongoing part of the Quality Management System There must be a start point

15 Product realisation ICH Q9 Quality Risk Management Product realisation ICH Q8 Pharmaceutical Development ICH Q10 Pharmaceutical Quality System

16 Recent events

17 Recent events 80% of attendees said that their view of risk management had changed significantly/moderately

18 Recent events This session demonstrated that it s important to have people from various functions within a company working together to determine the full affect of the change. A. Tenant. This session also demonstrated that it s important to have a facilitator during an FMEA, as at times, the conversation went off topic or got too specific. A. Isbel.

19 Timeline

20 Topics reviewed Change control Multi disciplinary team Focus in risk identification Existing systems in place

21 Topics reviewed Equipment and facility Comparison between FTA and FMEA drew the same conclusions Don t assume mitigation is present or effective when identifying risks.

22 Topics reviewed New products Risk criteria must be established Flow charts

23 Topics reviewed Computerised systems Science based justifications knowledge Industry guidance

24 Multi disciplinary team Major findings

25 Major findings The risk management tool is not important FMEA is the most commonly used mechanism

26 Policy and plan in place Major findings

27 Major findings Consider professional facilitators during the early phase

28 Don t... Try to implement to the entire organisation all systems and processes at the same time, prioritise Make decisions without documenting the process and outcomes

29 Do... Keep your eye on the prize Patient safety Product quality

30 Do... Embrace and encourage different perspectives Scientific knowledge

31 Do... Limit the scope of any risk, problem or scenario

32 Do... Adhere to a timeframe Record the names of all people involved in a quality risk management episode

33 Do... Utilise quality risk management as a system and a methodology QRM

34 Questions But why? Jovan Montalto. Age, 2 years and 3 months

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