This content is current only at the time of printing. This document was printed on 22 June 2018. A current copy is located at https://apvma.gov.au/node/19691
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Veterinary chemical manufacturers need to provide details of their proposed response plan within 25 working days of the audit.
For most medium and larger manufacturers, the need to undergo an audit in accordance with the GMP audit procedure and to address non-conformances (NCs) should be seen in the context of their ongoing quality assurance and system improvement processes. It is not uncommon for manufacturers to undergo a number of internal audits, corporate and client audits in addition to their APVMA licensing audit.
Audit closure based on a plan of corrective actions
After the transitional period, for manufacturers with audit level 1 or 2 ratings, audits will normally be closed on the basis of an agreed plan, provided to and supported by the auditor. The auditor will need to provide a copy of the plan with their endorsement to the APVMA for approval.
The APVMA will consider both the audit report and auditor-endorsed corrective action plan or corrective action assessment as part of the audit review and closure process. They will advise the manufacturer of the outcome and confirm the next re-audit date. For the plan to gain approval, it needs to include timeframes for addressing the NCs, particularly for more serious NCs that may impact on product quality.
In most cases all NCs need to be addressed within six months, unless granted written approval from the APVMA for an extension.
Where the corrective actions include risk assessment or validation, the plan needs to include an outline of the parameters to be considered. Within six months of the audit, the licence holder or authorised manager must provide the APVMA with a statutory declaration confirming that all NCs identified for completion have been completed. All corrective actions will be formally reviewed at the next audit.
If the plan is not approved by the APVMA, the manufacturer will be allowed to lodge another two submissions with three weeks allowed for each. If an acceptable plan has not been provided to the APVMA within four months, the facility will be considered non-compliant and managed accordingly.
Audit closure based on the assessment of corrective actions
In view of the number and severity of NCs involved, facilities rated as audit level 3 or 4 need to provide evidence demonstrating the corrective and preventative actions have been undertaken to address each of the identified NCs. The evidence must be provided to the auditor within the timeframe specified by the APVMA, but generally not exceeding three months of the audit. While the APVMA may grant an extension, such allowances in the past have not proven useful in bringing facilities into compliance. It is envisaged that other compliance and enforcement tools may be used in such cases.
Some audit level 1 and 2 manufacturers may elect to have the corrective actions assessed by the auditor, particularly if they are uncertain about what may be required. This option may provide greater certainty for that the issue will not re-emerge as a repeat NC at the next audit. The APVMA must receive the Corrective action review form from the auditor within 6 months of the audit. These manufacturers may opt to confirm completion of some corrective actions by declaration and some by evidence assessment.
If satisfactory completion of all corrective actions is not completed within the required timeframe, the manufacturers will be non-compliant and managed accordingly.
Transitional arrangements and review
Audit closure on the basis of a response plan will be implemented by the APVMA on a case-by-case basis from 1 March 2016, for up to 12 months, depending on whether external factors, such as the clarity of the audit reports and manufacturer response plans, allows this to occur. The transitional phase is expected to commence with audit level 1 manufacturers.
It is not expected that the ‘closure by plan’ option will be available to new applicant for a licence though this may be considered case-by-case.
It is proposed that any audits conducted under previous arrangements would be closed under those arrangements, even if after the date of implementation.
The APVMA plans to review the audit scheduling and management arrangements at three and six years after commencement. During the first three years the effectiveness of the change will be monitored continuously to provide timely intervention, if required, which may include training for industry.