Registered medicines MRA Clearance Compliance Verification (non-sterile) TGA on-site audit Evidence List A Evidence List B API (non sterile) Registered medicines (sterile) MRA Clearance Compliance Verification TGA on-site audit API Evidence List A Evidence Lists B and C (sterile and biotech) Contract testing MRA Clearance Compliance Verification laboratories TGA on-site audit Evidence List A Evidence List D Contract sterilisers Note: A TGA on-site audit will usually be required where the listed or sponsor’s registered medicine is not regulated by the regulatory agency of the country in which the manufacturing site is located. Complementary Medicines and Traditional Chinese Medicines are commonly not regulated as medicines in other countries. Table 1(b) lists the specific documents required for the Compliance Verification assessment. Explanatory notes for some of these documents are set out in Appendix C. Table 1(b) – Documentary evidence requirements Required Evidence Comments/Exclusions Evidence List A Current GMP Certificate. Certificates must be sufficient to cover the scope of the Clearance application. (GLP for testing laboratory, certification to relevant ISO Standards for sterilisation facility). Evidence List B Current GMP Certificate. GMP agreements may be requested if the overseas manufacturer performs the Compliance release for supply function. Verification for: A list of all regulatory inspections Inspection reports must be applicable to conducted within the past 3 years and a the scope of the application. These may APIs (other than copy of the most recent inspection report. be sent to the TGA directly from the sterile and biotech) manufacturer. (Processing can be expedited if reports for two or more of the above inspections are provided). Non-sterile and listed medicines Details of any regulatory actions in past 3 For example, product alerts, warning years. letters, import alerts, recalls due to defects. Site Master File, Quality Manual or Not required if the scope of the equivalent. application is only for the step of release
Registered medicines (non-sterile) MRA Clearance Evidence List A Compliance Verification Evidence List B TGA on-site audit API (non sterile) Registered medicines (sterile) MRA Clearance Evidence List A Compliance Verification Evidence Lists B and C TGA on-site audit API (sterile and biotech) Contract testing laboratories MRA Clearance Evidence List A Compliance Verification Evidence List D TGA on-site audit Contract sterilisers Note: A TGA on-site audit will usually be required where the sponsor’s listed or registered medicine is not regulated by the regulatory agency of the country in which the manufacturing site is located. Complementary Medicines and Traditional Chinese Medicines are commonly not regulated as medicines in other countries. Table 1(b) lists the specific documents required for the Compliance Verification assessment. Explanatory notes for some of these documents are set out in Appendix C. Table 1(b) – Documentary evidence requirements Required Evidence Comments/Exclusions Evidence List A Current GMP Certificate. (GLP for testing laboratory, certification to relevant ISO Standards for sterilisation facility). Certificates must be sufficient to cover the scope of the Clearance application. Evidence List B Compliance Verification for: APIs (other than sterile and biotech) Non-sterile and listed medicines Current GMP Certificate. GMP agreements may be requested if the overseas manufacturer performs the release for supply function. A list of all regulatory inspections conducted within the past 3 years and a copy of the most recent inspection report. (Processing can be expedited if reports for two or more of the above inspections are provided). Inspection reports must be applicable to the scope of the application. These may be sent to the TGA directly from the manufacturer. Details of any regulatory actions in past 3 years. For example, product alerts, warning letters, import alerts, recalls due to defects. Site Master File, Quality Manual or equivalent. Not required if the scope of the application is only for the step of release