Good Manufacturing Practice Audit Forms
Updated licence application and GMP audit documents for veterinary chemical product manufacturers are now available below. The majority of documents are effective from 4 September 2009. For ease of use, the documents are listed in two sections: 'For Manufacturers' and 'For Auditors'.
Manufacturers are encouraged to review the updated documents, in particular the revised 'GMP Audit Procedure' (KP80_W05) and should ensure current versions of forms are used when arranging and responding to GMP audits.
- GMP Audit Procedure Work Instruction (KP80W05) (PDF, 404kb)
- APVMA-authorised Good Manufacturing Practice auditors (PDF, 273kb) | (RTF, 4.36Mb)
For manufacturers:
- Application for a Licence to Manufacture Veterinary Chemical Products (DOC, 202kb) (form KP80_F01)
- Pre-Audit Notification and Information Form (Australian sites) (DOC, 140kb) (form KP80_F04)
- Response to GMP Audit Report (DOC, 68kb) (form KP80_F26)
- GMP Audit Checklist for Manufacturers (DOC, 1.21MB) (form KP80_F33)
- Cancellation of a Licence – Request Form (DOC, 38kb) (form KP80_F40)
- Manufacturers Response to Report of Unannounced GMP Audit (DOC, 55kb) (form KP80_F42)
- Request for a Certificate of GMP Compliance of a Manufacturer issued under the provisions of the MRA between Australian and the European Community (EC) (DOC, 86kb) (form KP80_F39)
For auditors:
- Confirmation of Audit Booking Form (DOC, 40kb) (form KP80_F23)
- Notification of Completed Audit Form (DOC, 78kb) (form KP80_F06)
- GMP Audit Report (KP80F05) (DOC, 182kb) (form KP80_F05)
- GMP Audit Report Supplement – Annex 1 (KP80F27) (DOC, 83kb) (form KP80_F27)
- GMP Audit Report Supplement – Annex 2 (KP80F28) (DOC, 88kb) (form KP80_F28)
- GMP Audit Report Supplement – Annex 3 (KP80F29) (DOC, 46kb) (form KP80_F29)
- GMP Audit Report Supplement – Annex 4 (KP80F30) (DOC, 41kb) (form KP80_F30)
- GMP Audit Report Supplement – Annex 5 (KP80F31) (DOC, 53kb) (form KP80_F31)
- GMP Audit Report Supplement – Annex 6 (KP80F32) (DOC, 53kb) (form KP80_F32)
- Corrective Action Review & Audit Close-Out Form (DOC, 48kb) (form KP80_F24)
Should you have any problems using or accessing the documents, please contact GMP Section on MLS@apvma.gov.au or 02 6210 4805.