GMP is a set of principles and procedures which, when followed by manufacturers of therapeutic goods, food and cosmetic agents, helps ensure that the products manufactured will have the required quality. A basic principle of the code of GMP (cGMP) is that quality cannot be tested into one batch of product but must be built into each batch of product during all stages of the manufacturing process.
GMP in Australia
In Australia, the Therapeutic Goods Act 1989 (TGAct) requires, with certain exceptions, manufacturers of therapeutic goods to hold a licence to manufacture. It is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are given exemption.
To obtain a licence to manufacture therapeutic goods a manufacturer must demonstrate – during an audit – compliance with manufacturing principles which includes relevant Codes of GMP and Quality Systems.
Overseas manufacturers of therapeutic goods which are supplied to Australia are required to meet an acceptable standard of GMP comparable to that required by Australian manufacturers. Sponsors of overseas manufacturers must provide evidence to the TGA that the goods are manufactured to a standard of GMP equivalent to that expected of Australian manufacturers of similar goods. If acceptable documentary GMP evidence cannot be provided the TGA will undertake on-site audits in the same manner as that conducted for the Australian manufacturers.
Australia is committed to several international arrangements, including Mutual Recognition Agreements (MRAs), the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and other arrangements that safeguard the exchange of regulatory information. The scope of these arrangements is summarised below.
Mutual Recognition Agreement (MRA)
The TGA currently has MRAs with several countries in the European Community (EC) and European Free Trade Association (EFTA) as well as Canada, Singapore & Switzerland. Inspections performed by the Authorities in their own countries are accepted in lieu of the TGA visiting sites in these countries.
Inspections performed by MRA countries outside their own country undergo a higher level of review, by way of a desk-top audit. Again, the intent here is to expedite clearance of a particular site without the need for the TGA inspections.
Pharmaceutical Inspection Convention & Pharmaceutical Inspection Co-operation Scheme (PICS)
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) are two international instruments between countries and pharmaceutical inspection authorities which together provide an active and constructive co-operation in the field of GMP. Australia is one of 37 participating authorities in this scheme. Partner organisations to this scheme include the European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), UNICEF and WHO.
This scheme is achieved by: developing and promoting harmonised GMP standards and guidance documents; training competent authorities, in particular inspectors; assessing (and reassessing) inspectorates; and facilitating the co-operation and networking for competent authorities and international organisations.
US FDA & Australia's TGA
The FDA and TGA, as well as other regulatory agencies, exchange information in relation to drug development, in particular manufacturing processes. Reports of inspection from the FDA undergo a desk-top audit prior to clearance of the site.
Currently a pilot project is being evaluated by the FDA, EMA and TGA to collaborate on GMP inspection activities. This project is primarily focused with reducing the duplication of inspections internationally and on developing consistency amongst the regulatory authorities.
More information on the TGA's international work can be found on their website at http://www.tga.gov.au/about/international.htm