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GMP clearance guidance

Version 18.1, January 2019

4 January 2019

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Evidence naming conventions

The table below outlines the naming conventions for evidence being uploaded with your GMP Clearance application.

Each piece of evidence should be provided as a separate file. If supplying multiple documents in response to a single item of evidence (for example a SMF and separate appendices), please provide a single zip file.

You will need to name each file with the document number prefix and the required file name to validate your application, for example:

  • 8 Release SOP

You cannot add additional text before the required naming convention as this will fail validation. For example, the following will fail the validation rule:

  • 8 Company Name Release SOP
  • Company Name 8 Release SOP

You can add additional text after the required naming convention. For example:

  • 8 Release SOP - Company Name - Effective Date
File naming convention table
Prefix # Evidence name The beginning of the file name (including the prefix number)
1 Current GMP or GLP or ISO Certificate 1 Certificate
2 Most recent inspection report 2 Inspection Report
3 Regulatory Inspections list 3 Regulatory Inspection List
4 Regulatory Actions Details 4 Regulatory Action Details
5 Site Master File or Quality Manual or equivalent 5 Site Master File or SMF or Quality Manual or QM
6 GMP or Quality or Technical Agreement or equivalent 6 GMP or Quality or Technical or Agreement or TA or QA
7 List of Products intended for supply in Australia 7 Product List
8 Release for supply procedure 8 Release for Supply procedure or Release SOP
9 Validation Master Plan 9 Validation Master Plan or VMP
10 Latest Product Quality Review 10 Product Quality Review or PQR
11 Authorised laboratory tests 11 Lab test
12 Manufacturer's declaration for Active Pharmaceutical Ingredients (APIs) 12 Declaration
13 Certified translation statement 13 Translation
14 Copy of the certificate of registration or a letter from the registrar in the manufacturer's country confirming the change of name 14 Name or Address Change
15 Cover letter detailing extension request and reason 15 Letter
16 Cover letter requesting change 16 Letter
17 Botanical ingredients evidence for authenticated standard reference materials 17 Botanical authenticated standard reference materials
18 LoA to Clearance 18 LoA Clearance
19 LoA to Evidence 19 LoA Evidence

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