TGA quality risk management requirements from July 1st 2010

John MontaltoSenior Consultant PharmOut Pty Ltd

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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

john.montalto@pharmout.com.au

www.pharmout.com.au