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Australian manufacturing licences and overseas GMP certification

A step-by-step guide

19 March 2019

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11: Preparing for inspection

Prior to the inspection, please ensure you confirm your readiness for inspection. An inspector will contact the manufacturing site(s) to discuss:

  • the members of the inspection team
  • any requests for additional information to support the application, such as:
    • the current Site Master File or Quality Manual
    • details of products manufactured since the last inspection (if relevant, for example for reinspection)
    • details of any significant changes made since the last inspection (if relevant, for example for reinspection)
  • any other information the inspector deems relevant

We may request electronic copies of records or other documents, such as Standard Operating Procedures (SOPs), validation plans, lists of products manufactured, any regulatory actions taken (recalls or product alerts) et cetera.

In most cases, we will contact the manufacturing site to arrange the inspection; however, we may also need to contact the sponsor for information relating to the inspection.

All documents supplied to the TGA must be in English or accompanied by an English translation.

Documents should be provided in an electronic format.

Book pagination