Date of first advice: 1 April 2020
Date of current advice: 26 February 2021
Date range for affected audits: December 2021
Background
Following the World Health Organization’s 11 March 2020 declaration of the novel coronavirus (COVID-19) pandemic, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is providing support to holders and manufacturers of veterinary medicines.
The COVID pandemic has resulted in travel restrictions and guidelines for social distancing that have affected the ability to perform Good Manufacturing Practice (GMP) inspections in Australia and overseas.
The APVMA has developed the following guidance to allow veterinary manufacturers audited by the APVMA to demonstrate compliance with GMP while travel restrictions and other measures are in place.
Review of this advice
Due to the evolving nature of the pandemic, this advice may change. To be notified of updates to this page and the guidance for holders about COVID, please complete a subscription form.
Evidence of compliance with GMP
The goal of an audit (as outlined in this advice) is to provide sufficient evidence for the APVMA to assess whether the legislative requirements in relation to GMP have been satisfied. Audits should still be conducted according to the APVMA Good Manufacturing Practice (GMP) Audit Procedure.
Audit types
In-person audits remain the preferred option when it is safe to do so. Otherwise, manufacturers should contact their auditor to discuss remote or hybrid options. During the consideration of what audit option will work best, holders, manufacturers and auditors may wish to refer to guidance documents on remote audits, for example, from the International Organisation for Standardisation and the Therapeutic Goods Administration.
Audit types, including remote and hybrid audits, are considered below.
In-person audits
In-person or face-to-face audits are the traditional onsite audit format that has been used by APVMA auditors, requiring the physical presence of an auditor on-site at a manufacturing facility and assistance by staff of the manufacturing facility in order to conduct the audit.
Remote audits
Remote audits are audits conducted from a distance. This format might be restricted to a desk audit of the GMP system, including evidentiary documents and records, standard operating procedures, and other relevant documents provided to the auditor. Remote audits might be facilitated by real-time communication with an auditee, including video and audio media and sharing of documentation online, and potentially real-time video of a tour of a facility.
Hybrid audit
A hybrid audit is any combination of in-person and remote components of an audit. The complete audit should be finalised as soon as practicable, but the face-to-face component should be completed only when it is considered safe to do so.
For overseas sites of manufacture
While travel and other restrictions due to COVID are in place, manufacturers and holders can refer to the following advice in Table 1 for overseas manufacturing locations.
| Manufacturer location | Auditing competent authority | Acceptable evidence |
|---|---|---|
Countries with established agreement (e.g. MRA, MOU etc.) with Australia Including: EU, USA, NZ, Canada | Recognised competent authority in the agreement document | A Certificate of GMP compliance by the relevant authority |
Other countries
| USA or EU country assessment of manufacturing facility in a third country; or, an audit by a PIC/S Participating Authority
|
|
| APVMA Auditors | APVMA audit |
More information
Manufacturers and holders are encouraged to monitor the advice for their products and to contact the APVMA if they have questions or concerns.
There are no anticipated changes to the process for export certificates.
Manufacturers who undergo an audit for the purposes of the EC-MRA or under PICS should contact the Therapeutic Goods Administration Manufacturing Quality Branch with questions regarding audit scheduling.
COVID-19 Corrective Action Progress Review Form (FM_MQL_COVID-19) [downloadable form – 41 KB]
Phone: +61 2 6770 2301
Email: MQL@apvma.gov.au
More information: Find out more about Good Manufacturing Practice.