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Guidance on licensing/certification inspections
Version 1.0, April 2013
The Office of Manufacturing Quality
The Office of Manufacturing Quality (OMQ) is responsible for assessing compliance with Good Manufacturing Practice (GMP) and Quality Management System (QMS) standards of Australian and overseas manufacturers of therapeutic goods in accordance with the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the Regulations), including:
- Inspecting and licensing of Australian manufacturers of therapeutic goods for supply in Australia and for export
- Assessment and approval of overseas manufacturers supplying therapeutic goods to Australia
- Note: Assessment of an overseas medicine manufacturer’s compliance can be performed either by on-site inspections or through GMP clearance for overseas manufacturers. This Guideline focuses on the inspection program of domestic and overseas manufacturers of therapeutic goods. Guidelines regarding the GMP clearance program are provided in the Australian Regulatory Guidelines Good Manufacturing practice (GMP) Clearance for Overseas Manufacturers
- Special inspections to investigate problem reports and recalls of therapeutic goods.
This Guideline focuses on the inspection program of domestic and overseas manufacturers but excludes the processes for the inspection of manufacturers regulated under the Biologicals Framework. These include human tissues and human cellular therapy products.
The OMQ inspection program
The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards, as legislated in the Act and Regulations, including the Manufacturing Principles and the Therapeutic Goods Orders.
The Act requires that overseas manufacturers of medicines and other therapeutic goods that are not medical devices, supplied in Australia, meet an acceptable standard of GMP comparable to that required for Australian manufacturers. If acceptable documentary GMP evidence cannot be provided, the TGA will undertake on-site inspections in the same manner as that conducted for the Australian manufacturers.
Manufacturers of medical devices supplied in Australia must demonstrate that Conformity Assessment Procedures have been applied to demonstrate that a product conforms to the essential principles of safety and performance. Manufacturers implement a quality management system based on recognised standards and have the system assessed by the TGA or a recognised conformity assessment body (overseas manufacturers only). Sponsors must declare that manufacturers have met their obligations and be able to provide relevant technical and quality management system documentation to support this claim.
When requested, the TGA is able to issue GMP or QMS certificates to approved manufacturers.
International involvement of the TGA includes development and maintenance of agreements with overseas authorities, participation in the development of international standards, and training of overseas inspectors. These international agreements may mean that the TGA can accept the results of an inspection from an overseas regulatory authority as outlined in the Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers.
The TGA conducts inspections on a third party basis only and is independent of all manufacturers inspected.
Regulating medicines manufacture
Australian manufacturers of all types of therapeutic medicines must be licensed under Part 3.3 of the Therapeutic Goods Act 1989 and must comply with the principles of GMP, unless specifically exempted. Overseas manufacturers of medicines imported into Australia must comply with an equivalent standard of GMP.
Medicines assessed as having a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the Australian Register of Therapeutic Goods (ARTG). Medicines having a lower risk (consumer medicines purchased over the counter such as complementary medicines including vitamins) are assessed for quality and safety. In assessing the level of risk, factors such as the effects and side effects of a product, potential harm through prolonged use, toxicity and the seriousness of the medical condition for which the product is intended to be used, are all taken into account.
Licensing or certification of medicines manufacturers, or the verification of compliance of overseas medicine manufacturers, is part of the assessment of medicines for their inclusion in the ARTG. Once approved for marketing in Australia, medicines on the ARTG can be identified by the AUST R number (for registered medicines) or an AUST L number (for listed medicines) that appears on the packaging of the medicine.
Regulating medical devices manufacture
Australian manufacturers of medical devices, and other specified manufacturers of devices incorporating a medicine or biological material, must be issued with a Conformity Assessment Certificate under Part 4 of the Therapeutic Goods Act 1989. Their quality management systems must comply with a recognised QMS standard.
All other overseas manufacturers must have evidence of the application of the conformity assessment procedures. This evidence is usually in the form of an equivalent assessment undertaken by recognised conformity assessment bodies.
All medical devices must have been demonstrated, and declared, by their manufacturer to conform to the Essential Principles of Safety and Performance for medical devices. The design of a medical device with a higher risk (pacemakers, coronary stents or incorporating a medicinal substance or biological material) is required to be independently assessed for conformity. Technical documentation for medical devices of lower risk (powered and non-powered hospital equipment, blood bags, and surgical instruments) is sampled during a quality management system inspection. The risk classification of devices is determined from the duration of use, the degree of invasiveness, the location of use and whether or not the device relies upon a source of energy.
Once approved for marketing a medical device is included in the ARTG. It is not required to bear the inclusion number on the labelling or packaging, however the name and address details of both the manufacturer and sponsor must be provided with the device.
Manufacturers are required to implement a comprehensive post market vigilance and adverse incident reporting program.