Risk Based Approach to Inspection Frequency Doreene Kohalmi Senior - - PowerPoint PPT Presentation

Risk Based Approach to Inspection Frequency

GMP Forum – 26 June 2018 Doreene Kohalmi Senior GMP Inspector Manufacturing Quality Branch

TGA compliance risk framework

Risk Based Approach to Inspection Frequency – TGA Forum June 2018

Low compliance risk High compliance risk

Committed to doing the right thing / Trying to do the right thing but don’t always succeed / Don’t want to comply but will if made to

Regulated entity – attitude to compliance

Voluntary compliance

• Effective compliance

systems

• M anagement is

compliance orientated

Accidental non-compliance

• Ineffective and/or developing

compliance systems

• M anagement compliance
• rientated but lacks capability

Opportunistic non-compliance

• Resistance to compliance
• Limited poor compliance systems
• M anagement not compliance
• rientated

Intentional non-compliance

• Deliberate non-compliance
• No compliance systems
• Criminal intent

TGA’s Approach to compliance

Help and support

• M ake ongoing

compliance easy

Inform and advise

• Help to become and stay

compliant

Correct behaviour

• Deter by detection

Enforce

1

TGA risk based re-inspection frequency

Number of deficiencies 0 major & < 10 other 1-5 major & < 20 other 6-10 major & < 30 other > 10 major & Any critical

Risk category 3rd consecutive A1 2nd consecutive A1 1st A1 A2 1st A3 Repeat A3 Unacceptable HIGH Sterile medicines, primary packaging of sterile medicines, non-sterile medicines containing potent actives (antibiotics, steroids, hormones antineoplastics), biotechnology APIs, sterile APIs for aseptic use & single step sterilisers M onths to re- inspection 36 + possible reduced scope 36 24 18 12 Compliance management Compliance management M EDIUM Registered non-sterile medicines (including registered herbal) & other APIs for use with sterile preparations that undergo a subsequent sterilisation step (filtration or terminal sterilisation) and not included in the high risk category M onths to re- inspection 36 + possible reduced scope 36 30 20 15 Compliance management Compliance management LOW Sunscreens, medicinal gases, non-sterile APIs for registered medicines & single manufacturing steps such as analysis & testing, labelling, secondary packaging, release for supply & storage M onths to re- inspection 36 + possible reduced scope 36 + possible reduced scope 36 24 18 Compliance management Compliance management LOW - LISTED Listed medicines M onths to re- inspection 48 + possible reduced scope 48 42 30 18 12 Compliance management

Risk Based Approach to Inspection Frequency – TGA Forum June 2018 2

Initial inspections

Domestic inspections

• The first re-inspection following the initial inspection of a domestic manufacturing site should be scheduled to
• ccur within 12 months irrespective of the compliance rating.

Overseas inspections

• The first re-inspection following the initial inspection of an overseas manufacturing site by TGA is dependent
• n available information to make a risk assessment:

– Should be scheduled within 12 months if the site is a new site and there is no compliance history with the local regulator. – Can be based on the timeframes specified in the re-inspection frequency table if the site is subject to regulatory

• versight by a local regulatory body and/or a recognised PIC/S or MRA partner and the site has an established history
• f manufacture of the specific dosage forms of interest at that site under a mature pharmaceutical quality system.

Risk Based Approach to Inspection Frequency – TGA Forum June 2018 3

Compliance issues triggered inspections

• Compliance triggered inspections can be both announced inspections brought forward from the routine re-

inspection frequency and unannounced inspections.

• After the review of all relevant compliance information an unannounced inspection will be recommended if it

is determined that the true extent of compliance is best determined by an unannounced inspection.

• Reasons for conducting an unannounced inspection include:

– Information received from other Branches within TGA, overseas regulators and external sources such as tip-offs. – The information received indicates that deficiencies may be covered up in case of advance announcement

• f an inspection.

– Inadequate responses to deficiencies raised at the last announced inspection. – The nature and extent of deficiencies raised and the trending of the manufacturing sites compliance history.

Risk Based Approach to Inspection Frequency June 2018 4

Medicines & APIs

Regulatory compliance is the minimum acceptable standard to ensure patient safety & product quality

M arket Leaders strive for the pursuit of excellence & innovation to not only ensure patient safety & product quality but also help protect brand image & build market share

Risk Based Approach to Inspection Frequency – TGA Forum June 2018 5