Presentation: Manufacturing medical devices
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The document outlines the role of the Office of Manufacturing Quality (OMQ) in overseeing manufacturing practices for medical devices under TGA regulations. It details basic manufacturer requirements, including compliance with ISO 13485 standards, risk-based assessment processes, and the importance of regular inspections to manage product and compliance risks. The conclusion emphasizes that the OMQ's inspection program helps ensure safety and efficacy in medical device manufacturing.
Presentation: Manufacturing medical devices
- 1. Manufacturing medical devices Regulatory considerations Dr Ying Huang Inspector, Office of Manufacturing Quality (OMQ) Monitoring and Compliance Group, TGA ! ABEC - Canberra 21 August 2014 1
- 2. ABEC - Canberra Topics ➢Role of the Office of Manufacturing Quality (OMQ) ➢Basic requirements for a manufacturer ➢Risk-based program of manufacturer assessment –Regulate risks relating to product –Regulate risks relating to compliance ➢Conclusion 2
- 3. Role of OMQ 3 Australian and overseas manufacturers are assessed prior to supply of goods and are then regularly reviewed Inspections against conformity assessment procedures (ISO 13485) and other standards (e.g. sterilisation standards) Quality manufacturing On-site inspections of manufacturers and compliance verifications (desktop assessments)
- 4. ABEC - Canberra Basic requirements for a manufacturer ➢Manufacturer applies a relevant conformity assessment procedure (CAP) to demonstrate: •Compliance with Essential Principles (EPs); and •Implementation of an effective Quality Management System (QMS) ➢Essential Principles •14 principles for performance and safety, including: •General risk management; •Clinical evidence; •Others 4
- 5. ABEC - Canberra Risk-based program of manufacturer assessment 5 The TGA regulatory framework: The risks involved with therapeutic goods can be divided into: 1.Risks relating to the product. 2.Risks relating to compliance. Compliance risks relate to the risks involved if a manufacturer or sponsor fails to comply with legal requirements (either unintentionally or intentionally)
- 6. ABEC - Canberra Risk-based program of manufacturer assessment 6 Different types of QMS: The level of assessment by TGA Part 1 Full Quality Assurance Part 4 Production Quality Assurance Part 5 Product Quality Assurance The level of risks for the device
- 7. ABEC - Canberra Regulate risks relating to product 7 Part 1–Full Quality Assurance for manufacturing including design and development Documents to define the QMS and records to show the system has been applied (clause 4) Management controls (clause 5) Resource (human, infrastructure and work environment) management (clause 6) Design & development control (subclause 7.3) Purchase: outsourced processes and suppliers (subclause 7.4) Production and service provision (subclause 7.5) Measurement, analysis and improvement processes (clause 8) Risk management applying throughout product realisation
- 8. ABEC - Canberra Regulate risks relating to compliance Independent and periodic inspection of a manufacturer: •By OMQ : ▪Specifically for combination products: •Medicines •Animal origin •Microbial substance •Blood components ▪Types of Inspections •Full •Partial / Surveillance •Unannounced 8 And / Or •By recognised third parties: ▪EU Notified Bodies; and ▪CMDCAS Registrars (for Health Canada)
- 9. ABEC - Canberra Regulate risks relating to compliance 9 Desktop assessment ➢An alternate way to assess the quality of manufacturing of medical devices ➢The assessment criteria are the same as the on-site inspection. ➢Further on-site inspection may be recommended pending on the desktop assessment outcome. ➢Benefit: •Reduce regulatory burden; and •Efficiently utilise resources.
- 10. ABEC - Canberra Regulate risks relating to compliance ➢Monitor post-market adverse events –Regulatory requirements—notification (subclause 8.5.1 of ISO 13485) ▪Adverse-event reporting & recalls; and ▪Significant changes in device or QMS ➢Undertake a program of laboratory compliance testing 10 To complement the inspection program, other areas of TGA:
- 11. ABEC - Canberra 11 Conclusion 1.The TGA manages the risks associated with medical devices by regulating: •Risks relating to product through product assessment and inspection of manufacturers; and •Risks relating to compliance through post-market compliance activities including unannounced inspections for problem/complaint investigations. 2.The Office of Manufacturing Quality (OMQ) contributes to TGA’s objectives through the implementation of the inspection program. 3.ISO 13485 QMS standard has been specified by the conformity assessment standards order as a tool to assess the manufacturer's QMS.
- 12. Thank you for your attention.