If you are considering recalling a therapeutic good, follow the recall procedure.
On this page: Sponsor-manufacturer agreement | Medicine manufacturers | Investigating manufacturing issues | Keeping records | Analysing risk | Root cause analysis | Corrective and preventative actions (CAPA)
The manufacturer and sponsor should have an agreement to ensure that both parties can meet their responsibilities relating to any potential recall.
Note: This is not necessary when the manufacturer is also the sponsor.
Medicine manufacturers require systems to:
- recall any batch of goods from sale or supply
- investigate any issue, including the root cause
- implement CAPAs.
Related information and guidance
Refer to the PIC/S Guide to GMP for Medicinal Products (the PIC/S Guide) for specific references to therapeutic goods recalls.
For Australian manufacturers with a TGA licence
It is a condition of the licence that you inform us promptly if you intend to initiate a recall.
Investigating manufacturing issues
Manufacturers are responsible for investigating issues in the manufacturing process that can sometimes lead to a recall. For example, issues with:
- a batch of raw material
- a component part
- the manufacturing process
- the final goods.
All manufacturers need to maintain records.
Manufacturers in Australia
Medical device manufacturers keep records for at least 5 years from the last date of manufacture, or for the lifetime of the device, whichever is longer.
Medicine manufacturers retain complete records pertaining to the medicines. The timeframe for keeping these records depends on the expiry date:
- no expiry date: at least six years after manufacture
- with an expiry date: at least one year after the expiry date.
It must be possible to trace the complete history of a batch using understandable, accessible records of manufacture and distribution, as detailed in the PIC/S Guide.
Biologicals' manufacturers retain complete records pertaining to the biologicals for five years (see section 32JA of the Therapeutic Goods Act 1989).
Manufacturers are responsible for conducting risk analyses and investigating medicines, medical devices, biologicals, human blood and blood components.
Medical device risk analysis
Manufacturers are responsible for analysing the potential risks associated with an adverse event, goods failure or complaint using an appropriate QMS as described in ISO 14971 Medical devices – application of risk management to medical devices.
Medical device manufacturers require, as part of an effective QMS (usually in accordance with ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes):
- a system to recall any batch of goods by notifying sponsors or distributors
- a system to investigate any issue, including identification of root cause and implementation of CAPAs
Related information and guidance
- Section 6 of the Australian Regulatory Guidelines for Medical Devices
- IVD conformity assessment overview
Biologicals, human blood and blood components
The Code of GMP for human blood and blood components, human tissues and human cellular therapy products requires manufacturers to investigate adverse events and complaints, and to implement and maintain a written procedure for recalling goods.
Root cause analysis
The manufacturer usually conducts the root cause analysis in parallel with the recall.
Corrective and preventative actions (CAPA)
When manufacturers identify a manufacturing issue, they implement CAPAs. Sometimes we will ask for the full CAPA report.