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

Risk Based Approach to Inspection Frequency Doreene Kohalmi Senior GMP Inspector Manufacturing Quality Branch GMP Forum – 26 June 2018

TGA compliance risk framework 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 Accidental non-compliance Opportunistic non-compliance Intentional non-compliance • • • • Effective compliance Ineffective and/or developing Resistance to compliance Deliberate non-compliance • • systems compliance systems Limited poor compliance systems No compliance systems • • • • M anagement is M anagement compliance M anagement not compliance Criminal intent compliance orientated orientated but lacks capability orientated TGA’s Approach to compliance Help and support Inform and advise Correct behaviour Enforce • • • M ake ongoing Help to become and stay Deter by detection compliance easy compliant Risk Based Approach to Inspection Frequency – TGA Forum June 2018 1

TGA risk based re-inspection frequency Number of 0 major & < 10 other 1-5 major & 6-10 major & < 30 other > 10 major & deficiencies < 20 other Any critical 3 rd consecutive A1 2 nd consecutive A1 1 st A1 1 st A3 Risk category A2 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- 36 + possible 36 24 18 12 Compliance Compliance inspection reduced scope management 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- 36 + possible 36 30 20 15 Compliance Compliance inspection reduced scope management 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- 36 + possible 36 + possible 36 24 18 Compliance Compliance inspection reduced scope reduced scope management management LOW - LISTED Listed medicines M onths to re- 48 + possible 48 42 30 18 12 Compliance inspection reduced scope 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 occur 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 on 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 oversight by a local regulatory body and/or a recognised PIC/S or MRA partner and the site has an established history of 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 of 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 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 Regulatory compliance is the minimum acceptable standard to ensure patient safety & product quality Risk Based Approach to Inspection Frequency – TGA Forum June 2018 5