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Quality Risk Managementwhat’s happening, the TGA and the how to
Timelines
• July 1, 2010 the PIC/S GMP Guide replaces the current TGA code of GMP
– The decision was made on 29th July 2009 and is referred to as ‘Determination No. 1’
Major changes to the GMP code
Quality Risk Management
Product quality review
Ongoing stability program
Manufacture of sterile medicines
GMP says
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
Critical changes – QRM
• Annex 20 (Quality Risk Management) application is voluntary
– Your quality system must include a “systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product”, but you may choose whether to follow Annex 20, or some other valid risk management process
Who is affected?
• All medicinal manufacturers covered by the Australian code of GMP, 2002.
• API manufacturers
Annex 20 Quality Risk Management
Severity
Opportunity
Detection
Competition and regulation
• Need to focus skilled resources where risks to patient safety are highest
• Do more with less– Maximise resource effectiveness
QRM
If everything is critical, nothing is critical
Assessing risk
What might go wrong?
What is the likelihood it will go wrong?
What are the consequences?
Identifying risk
Sources of data may be more apparent than you think
Analyse risk
Quantify and qualify risk
Evaluate risk
Compare the risk to your pre-determined criteria
Control risk
• Mitigate– eliminate
• Transfer
• Avoid
• Reduce
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.
Communication
Sharing risk information
Review risk
Ongoing part of the Quality Management System
• There must be a start point
Product realisation
At a recent TGA facilitated Quality Risk Management event
80% of attendees said that their view of risk management had changed significantly/moderately
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.
Timeline
Major findings
Multi disciplinary team
Major findings
The risk management tool is not important
– FMEA is the most commonly used mechanism
Major findings
Policy and plan in place
Major findings
Consider professional facilitators during the early phase
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
Do...
Keep your eye on the prize
– Patient safety
– Product quality
Do...
Embrace and encourage different perspectives
– Scientific knowledge
Do...
Limit the scope of any risk, problem or scenario
Do...
Adhere to a timeframe
Record the names of all people involved in a quality risk management episode
Do...
Utilise quality risk management as a system and a methodology
QRM
Questions
“But why?”Jovan Montalto. Age, 2 years and 4 months
