Risk-based scheduling of GMP audits

The APVMA uses a risk-based approach to scheduling Good Manufacturing Practice (GMP) audits of veterinary manufacturing sites.

Using the risk-based approach outlined below, the APVMA can more effectively align its regulatory efforts with potential risks associated with each site. It also allows manufacturers to understand what they can do to improve their level of compliance and the benefits to them in doing so, especially with regard to lengthening audit intervals for their site.

Risk assessments

The intrinsic risk estimated for a manufacturing site reflects the complexity of the site, its processes and the products it produces there, as well as the criticality of the products and services from a supply perspective.

Categories

The intrinsic risks associated with the complexity of processes and the stringency of product quality requirements broadly align with the APVMA’s categories of manufacture listed in the table below.

Category     Product types
Category 1 Immunobiologicals and sterile veterinary preparations
Category 2 Non-sterile veterinary preparations other than ectoparasiticides, premixes and supplements
Category 3 Ectoparasiticides (externally applied)
Category 4 Premixes and supplements, including medicated blocks
Category 6 Single-step manufacturer, such as labelling and/or packaging

Note: Category 5 was reserved on commencement of the scheme and is not currently employed.

Within a category, the risks of individual products manufactured at a site can vary.

The Cost-recovery discussion paper identified how, generally, manufacturers of sterile and immunobiological (Category 1) products and multi-category manufacturers producing a range of product types frequently have more NCs—and the audits take longer to close—when compared to smaller, less complicated facilities.

Manufacturers with licences for single-step operations can range from low-risk sites engaged in secondary packaging and labelling to high-risk sites conducting contract analytical testing—or those engaged in terminal sterilization and irradiation. While the last group are relatively high-risk, such facilities are currently audited and licensed by the Therapeutic Goods Administration (TGA). Should any single-step sterilization facilities be audited by the APVMA, they would be audited according to the schedule for Category 1 facilities.

Multi-category manufacturers

Multi-category manufacturers are generally considered to be of higher intrinsic risk.

Where the operations of an individual multi-category manufacturer may be relatively uncomplicated, such as manufacturing products of only one dosage form, the APVMA may, at its discretion, schedule audits as if it were a single-category manufacturer.

Audit scheduling

Audit intervals

From 1 March 2016, audit intervals will be allocated to each manufacturing site based on the risk management plan outlined below in Table 1. This considers both the non-conformance score and the audit rating (audit level), as well as the risk profile associated with the type of manufacture undertaken.

These intervals apply equally to audits of domestic and overseas manufacturers.

Consistency extensions

Manufacturers who consistently demonstrate high-levels of compliance may be given an extension on their audit interval. The consistency extension will only be granted where the facility has maintained a rating of audit level 1 for two or more consecutive audits.

The incentive of small, incremental changes to a site’s audit schedule can encourage manufacturers to improve or maintain an effective quality management system, which in turn helps ensure they maintain high-levels of compliance.

The maximum audit intervals broadly align with those of other comparable agencies.

For manufacturers with audit level 3 and 4 ratings, the audit intervals are similar to those prior to 1 March 2016.

Table 1: GMP audit schedule

Audit rating Level 1 Level 2 Level 3 Level 4
NC Score Consistency extension 0–4 5–8 9–12 13–16 17–20 21–24 25–28 29–32 33–36 37–40 >40
Audit interval (in months)
Product related factors Cat 1 or Multi-Category 30 27 24 22 19 17 15 14 13 12 11 6–10
Cat 2 or Cat 3 only 33 30 27 24 21 18 16 15 14 13 12 10–12
Cat 4 or Cat 6 only 36 33 30 27 24 21 19 18 17 16 15 12–14

Exception for critical non-conformance

In situations when an audit identifies a critical non-conformance the manufacturer needs to implement immediate corrective actions, irrespective of their established audit rating or category. The schedule anticipates that other compliance and enforcement tools may be used to support auditing where appropriate.

Rescheduling audits

In exceptional circumstances, manufacturing licence holders can formally request to reschedule an audit.

Written requests, by email or post, may be based on:

  • recent major changes to management and/or staffing
  • factory fires or other unscheduled asset crises and any associated maintenance or repair activities
  • other circumstances, such as voluntary licence suspension where cessation of manufacture may mitigate many of the risks associated with the postponement of an audit.

In responding to such requests, the APVMA may take into consideration certification provided by other authorities, when relevant to the scope of the APVMA licence.

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