All medicine manufacturers must receive approval from the TGA prior to manufacture and supply of products in Australia, unless exemptions or other provisions apply. The TGA one of a few regulators who have adapted a desk top assessment process in lieu of an on-site inspection.
TGA GMP Regulations
The Therapeutic Goods Act 1989 sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia.
It details the requirements for listing, registering or including medicines, medical devices and biological products on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance.
What does the TGA do?
Its important to understand the scope of the TGA for GMP clearance. The TGA only assesses the manufacturing process not the specific product and its chemistry.
The TGA DOES DO:
- Review applications made by sponsors to determine whether the site complies with GMP
- Assess certificates, inspection reports, Site Master Files, Inspection History and other relevant documents to determine whether the site complies with the Manufacturing Principles.
- Assess whether the evidence supplied supports the application being made, ie the dosage forms and steps of manufacture selected within the application.
- Look at the overall systems and processes in place, not at individual products
THE TGA DOES NOT DO:
- Provide advice to sponsors about whether a specific product or steps of manufacture require a GMP Clearance.
- Refer questions to the product regulation area as they are the experts when it comes to the product requirements, application systems and validation rules.
TGA’s International Harmonization Agreements :
Mutual Recognition Agreement (MRA) pathway:
- Manufacturer is located within the borders of a MRA country
- Current target processing time: 30 TGA working days
- Slovak Replublic
- United Kingdom
- Czech Republic
- New Zealand
- United States Food and Drug Administration (US FDA)
- European Directorate for the Quality of Medicines (EDQM)
- Members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
Compliance Verification (CV) pathway:
- Manufacturer does not meet criteria for the MRA pathway but inspected by acceptable regulatory authority
The evidence requirements for GMP Clearance are considered carefully. They are based on risk and vary depending on;
- Manufacturer location
- Inspecting authority and agreement in place
- Risk/complexity of the product/process
- The evidence requirements for each application type are outlined within the GMP Clearance *Guidance document
*Most recent update was published in March 2019.
COVID-19 Impact on GMP for regulators
Even though, remote audits were available to Manufacturers prior to the pandemic it does not change the fact that Remote or Virtual GMP inspections adds another layer of complexity for regulators especially for overseas manufacturers.
It has lead the TGA to focus their GMP clearance efforts to :
- Increased collaboration with MRA partners and acceptance of ‘distant assessment’ certificates
- Aligning expiry dates in line with published industry guidance
- New GMP Clearance questionnaire to bridge gap since the last on-site inspection
- Ensure a more involved assessment by requesting additional documents as required
- Providing additional time for sponsors and manufacturers to address assessment questions
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.