Risk Assessment: An Industry Perspective Introduction of a New Molecule. Robert Caunce Quality Manager Technology Transfer

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1 Risk Assessment: An Industry Perspective Introduction of a New Molecule Robert Caunce Quality Manager Technology Transfer

2 Presentation Objective Good Science (A square does fit into a round hole) Risk Identification Consultation (Internally and Externally) Research, more research Risk Assessment RA-022 Next Stages 2

3 A Square Does Fit into a Round Hole Risk Assessment We all have been doing risk assessment for a number of years, we have just called it something else Change impact Deviation impact Batch quality impact Root cause analysis Risk Assessment should be based on good science and should not be too taxing on resources. Let s look at an out of world example 3

4 Apollo 13 We all must have seen the movie when the lunar module exploded. The NASA scientists had a problem and had to come up with a risk assessment and the mitigation measures. In this case if they did not fix the problem the consequence would be death of three Astronauts. A lot like our industry and patient safety. Did the NASA team sit down and perform a risk assessment and then go through all the possible consequences Yes they did 4

5 Apollo 13 The mailbox Limited available lithium hydroxide (LiOH) for removing carbon dioxide presented a serious problem. The LM's internal stock of LiOH canisters was not sufficient to support the crew until return, and the remainder was stored in the descent stage, out of reach. The CM had an adequate supply of canisters, but these were incompatible with the LM. Engineers on the ground improvised a way to join the cube-shaped CM canisters to the LM's cylindrical canister-sockets by drawing air through them with a suit return hose. The astronauts called the jury-rigged device "the mailbox". 5

6 Risk Assessment from the Regulatory Agencies Bringing us back to Earth and what we should have in place Risk register Periodic reviews of risk management assessments Standard operating procedure (SOP) Integrated within the quality system Defining how the QRM system operates Risk mitigation plans identified and implementation 6

7 Risk Assessment What does this mean? Clearly identify the process being assessed Systematic identification of possible risk factors Scientific knowledge Utilisation of the Subject Matter Experts Factual evidence 7

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9 Risk Assessment Risk Identification The area that we all need to spend more time Poor science Inadequate knowledge or experience Consultation We can not all be Subject Matter Experts 9

10 10 Remember To Include Everything In Your Risk Assessment

11 Research, More Research PDA Technical Report 44 Quality Risk Management for Aseptic Processes PDA Technical Report # Implementation of Quality Risk Management For Pharmaceutical and Biotechnology Manufacturing Operations ISPE Volume 7 Risk-Based Manufacture of Pharmaceutical Products A Guide to Managing Risks Associated with Cross- Contamination ISO Risk Management Principles and Guidelines ISO Risk Assessment Techniques ISO Guide 73 Vocabulary for Risk Management MSDS EHS risk assessments and Hygiene TGA drug information Industrial hygiene Product Information Internet 11

12 Risk Assessment - Monitoring and Review It should encompass all aspects of the risk management process for the purpose of: Controls are effective and efficient; Obtaining further information; Analysing and learning lessons from events Changes, trends, successes and failures; Detecting changes in external and internal context, Identifying emerging risks. 12

13 Risk Assessment - Communication and Consultation Communication and consultation should occur during all stages of the risk management process. Plans for communication and consultation should be developed at an early stage Consultative team approach 13

14 14 Risk Assessments Taken To Another Level

15 Aseptic Risk Assessment The following slides are a Real life example Of the utilisation Of the Risk Assessment Process 15

16 Risk Management for Aseptic Processing Aseptic processes are some of the most difficult processes to conduct in the pharmaceutical industry. Sterile products produced aseptically present a significant higher risk to the patient than terminally sterilised products Effective quality risk management program is necessary to protect the patient Control of the process, reducing the risk of contamination as well as wasted effort in controlling insignificant risks That was the challenge set 16

17 Aseptic Risk Management - A Real Life Example The questions normally raised by Management We have done this many times is the normal answer Our SOPs and processes Appropriate validations And finally We do not need to do a risk assessment It takes too long and utilises a lot of resources Those invited to the risk management meeting always find anyway of getting out of the meeting. 17

18 Risk Assessment For The New Molecule An initial risk assessment was created even before the new molecule arrived Processes were run, monitored and reviewed The risk assessment was reviewed and modified post the initial campaign, using lessons learnt. Monitoring the new process, enhancements and decision points was conducted. The journey does not stop. 18

19 How The Risk Assessment Was Conducted? The API (the critical part of the risk assessment) was followed throughout the whole process from inward goods through to the final product leaving the facility. New challenges for the facility were discussed with the subject matter experts and options were evaluated Process Maps were created for each step and procedures were reviewed and modified 19

20 Risk Assessment: Major Changes Replacement of some of the Filling machine and conveyor PVC curtains with polycarbonate. Installation of a three way pass-through. Creation a containment barrier in front of the Freeze dryer in Filling Room Provision of filtration to Filling Room return air Containment Air sinks to avoid any airborne contaminates leaving the facility 20

21 Benefits Of The Risk Assessment Quality risk management is an essential tool for qualification of aseptic processes. It is not just a tool for CGMP compliance; it offers real benefits to the validation process by identifying risks and ensuring that critical risks are controlled. By focusing managing risks to the patient, pharmaceutical manufacturers can ensure that the right resources are applied at the risk place at the right time-improving patient safety while eliminating unnecessary validation efforts. 21

22 The New Building Comes Alive after Modifications 22 I always wanted to be a mad scientist

23 To all Have a Merry Christmas and a Happy New Year Keep safe and spend times with the loved ones Maybe do a risk assessment» On the BBQ,» The Christmas presents» Or just forget them till next year 23

Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI

Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the