Operational Information - Manufacture of Veterinary Chemical Products
Forms and templates
| Document title | Description | Last updated |
|---|---|---|
| Application for a Licence to Manufacture Veterinary Chemical Products (RTF, 202kb) | Form to apply for a licence to manufacture veterinary chemical products | 12 February 2010 |
| Pre-Audit Notification and Information Form (Australian Sites) (RTF, 140kb) | Form for a manufacturer to complete before a GMP audit is conducted | 12 February 2010 |
| GMP Audit Report (RTF, 182kb) | Template for a GMP audit | 4 September 2009 |
| Notification of Completed Audit Form (RTF, 78kb) | Form to be completed by an auditor to notify the APVMA of a completed audit | 12 February 2010 |
| Confirmation of Audit Booking Form (RTF, 73kb) | Form to be completed by an auditor to confirm with the APVMA that an audit has been booked | 12 February 2010 |
| Corrective Action Review / Audit Close-Out Form (RTF, 82kb) |
Form to notify the APVMA and the manufacturer about a review of corrective actions and an audit close-out | 12 February 2010 |
| Response to GMP Audit Report (RTF, 95kb) | Manufacturer's response to an audit and feedback about the audit to the APVMA | 4 September 2009 |
| GMP Audit Report Supplement Annex 1 - Sterile Products (RTF, 102kb) | Supplement to a GMP audit report for sterile products | 4 September 2009 |
| GMP Audit Report Supplement Annex 2 - Immunobiological & other products of biological origin (RTF, 103kb) | Supplement to a GMP audit report for immunobiological and other products of biological origin | 4 September 2009 |
| GMP Audit Report Supplement Annex 3 - Non-sterile therapeutic products (other than ectoparasiticides, premixes, supplements and biological feed additives) (RTF, 71kb) | Supplement to a GMP audit report for non-sterile therapeutic products (other than ectoparasiticides, premixes, supplements and biological feed additives) | 4 September 2009 |
| GMP Audit Report Supplement Annex 4 - Herbal Products (RTF, 68kb) | Supplement to a GMP audit report for Herbal Products | 4 September 2009 |
| GMP Audit Report Supplement Annex 5 - Ectoparasiticides (RTF, 79kb) | Supplement to a GMP audit report for Ectoparasiticides | 4 September 2009 |
| GMP Audit Report Supplement Annex 6 - Premixes, Supplements & Biological Feed Additives (RTF, 76kb) | Supplement to a GMP audit report for Premixes, Supplements & Biological Feed Additives | 4 September 2009 |
| Request for a Certificate of GMP Compliance of a Manufacturer issued under the provisions of the MRA between Australia and the European Community (EC) (RTF, 86kb) | Application form to be completed by an APVMA-licensed manufacturer requesting a Certificate of GMP Compliance of a Manufacturer | 12 February 2010 |
| Cancellation of a Licence – Request Form (RTF, 68kb) | Form to request the voluntary cancellation of a licence to manufacture veterinary chemical products | 12 February 2010 |
| Manufacturer’s Response to Report of Unannounced GMP Audit (RTF, 83kb) | Form for a manufacturer to respond to the report of an unannounced GMP Audit | 4 September 2009 |
| Pre-Audit Notification and Information Form (Overseas Sites) (RTF, 380kb) | Form for a manufacturer to submit to the APVMA at least 4 weeks prior to the scheduled audit date | 10 August 2010 |
| Advice on GMP Status of Manufacturers - Australian and Overseas Sites - GMP Screening (RTF, 22KB) | GMP Screening form for Advice on GMP Status of Manufacturers - Australian and Overseas Sites (KP80F14) | 4 September 2009 |
| Licence Application Checklist (RTF, 64KB) | Checklist for a Licence Application (KP80F15) | 28 August 2009 |
| Licence to manufacture Veterinary Chemical Products (RTF, 176KB) | Template for a licence to manufacture Veterinary chemical Products (KP80F17) | 26 March 2008 |
| Notice of Suspension of a Manufacturer's Licence (RTF, 130KB) | Form for a Notice of Suspension of a Manufacturer's Licence (KP80_F18) | 18 December 2007 |
| Notice of Revocation of Suspension of a Manufacturer's Licence (RTF, 127KB) | Form for a Notice of Revocation of Suspension of a Manufacturer's Licence (KP80_F19) | 15 April 2008 |
| GMP Audit Review & Routine Audit Interval Risk Assessment (RTF, 67KB) | Form for a GMP Audit Review & Routine Audit Interval Risk Assessment | 28 August 2009 |
| Assessment of Post Registration GMP Complianceof Overseas Manufacturing Site (RTF, 23KB) | Form for an assessment of post registration GMP Compliance of overseas manufacturing site | 20 August 2008 |
| Notice of Variation to Conditions on a Licence to Manufacture Veterinary Chemical Products (RTF, 130KB) | Form for a Notice of Variation to Conditions on a Licence to Manufacture Veterinary Chemical Products | 3 December 2007 |
| Notice of Cancellation af a Manufacturer's Licence (RTF, 130KB) | Form for a Notice of Cancellation af a Manufacturer's Licence (KP80_F36) | 18 December 2007 |
| Notice of Revocation of Cancellation of a Manufacturer's Licence (RTF, 127KB) | Form for a Notice of Revocation of Cancellation of a Manufacturer's Licence (KP80_F37) | 15 April 2008 |
| Notice of Refusal of an Application for a Licence to Manufacture Veterinary Chemical Products (RTF, 128KB) | Form for a Notice Of Refusal Of An Application For A Licence To Manufacture Veterinary Chemical Products | 18 December 2007 |
| Report of Unannounced APVMA GMP Audit (RTF, 360KB) | Form for the report of an unannounced APVMA GMP Audit | 28 August 2009 |
| Report on Observed GMP Audit (RTF, 78KB) | GMP - Report on Observed GMP Audit | 28 August 2009 |
| GMP - Export Certificate Checklist (RTF, 44KB) | Checklist for export certificates (KP80_F44) | 10 September 2009 |
Procedures and work instructions
| Document title | Description | Last updated |
|---|---|---|
| GMP Audit Procedure (Australian Manufacturers) (PDF, 113kb) | Work instruction on how routine (full or partial) GMP audits of veterinary chemical manufacturing premises are to be conducted and reported. | 4 September 2009 |
| Issuing a Certificate of GMP Compliance of a Manufacturer (PDF, 60kb) | Work instruction for issuing a certificate of GMP compliance of a manufacturer under the provisions of the Mutual Recognition Agreements Between Australia, the European Community and the European Free Trade Association (PDF, 60kb) | 2 October 2009 |
| GMP - Licensing Enquiries (RTF, 153KB) | Instructions on how to process enquiries related to APVMA licensing of veterinary chemical product manufacturers | 10 September 2009 |
| Management and Processing of Licence Fees (for GMP) (RTF, 377KB) | Procedures to be followed by MQL Section when calculating, invoicing, managing, adjusting, receipting and processing, recovering and waiving licence fees in relation to the Manufacturer's Licensing Scheme (MLS) | 20 April 2011 |
| Preparation of Certificates of Export and/or Manufacture (with GMP) (RTF, 142KB) | Instructions for preparing certificates for export purposes, which require a statement regarding the manufacturer's GMP compliance and licence status | 10 September 2009 |
| Screening and Evaluation of Veterinary Chemical Product Applications to Assess GMP Compliance of Manufacturers (RTF, 131KB) | Instructions for screening and evaluating product applications to assess whether manufacturers of veterinary chemical products comply with good manufacturing practice (GMP) requirements | 4 September 2009 |
| Assessing Post-Registration GMP Compliance | Instructions for assessing post-registration compliance with the GMP conditions of product registration | Under Review |
| APVMA GMP Audits of Overseas Manufacturers | Instructions for processing, conducting and reviewing audits of overseas manufacturers for compliance with the Australian Code of Good Manufacturing Practice (GMP) for Veterinary Chemical Products | Under Review |
Last updated on
21 March, 2012