Impact of the New PIC/S Guide to Good Distribution Practice on Australian Wholesalers
Australian wholesalers and distributors currently must comply with the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8, issued in April 2011, whilst Australian manufactures comply with PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE-009-08.
However, a new GDP guide has been published this month by PIC/S – the PIC/S Guide to Good Distribution Practice for Medicinal Products. The PIC/S GDP Guide is based on the 2013 EU Guidelines on Good Distribution Practice.
There are substantial differences between the current Australian requirements and those of the PIC/S Guide to GDP.
Considering current Australian legislation requires Australian manufactures to adhere to PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE-009-08 could the PIC/S Guide to good distribution practice be in the not-too-distant future for Australian Wholesalers?
If Australia were to adopt the new PIC/S Guide to GDP, what would be the impact within the local distribution industry?
- Quality Risk Management (QRM) must be integrated throughout the Quality Management System (QMS)
- Compliant management of all outsourced activities
- Mandatory written contracts with all premises not controlled by the distributor
- Tighter controls around segregation/quarantine, equipment maintenance and calibration, and facility management
- Tighter controls for computer systems, in line with current Good Manufacturing Practice (GMP) expectations
- Improved validation and calibration expectations
- All suppliers and customers must be qualified
- Self-inspection is a mandated new requirement
- Tighter controls associated with transportation, particularly for temperature sensitive medicines
- Significant industry consultation and communication would be required, implying the need for a long ‘lead time’ before local implementation is realistically expected.
If Australia does not adopt the new PIC/S Guide to GDP, what is the impact to the industry when importing from countries that do?
Overseas manufacturers in countries where the PIC/S Guide to GMP is adopted will be required to ensure that their distribution chain complies with the PIC/S GDP requirements.
Therefore, Australian wholesalers will be required to demonstrate that they meet the PIC/S Guide to GMP, regardless of the local guidance.
Distribution and wholesalers must consider their ability to step up to the PIC/S level of compliance in light of the new international requirements. Already, some importers are required to meet the EU requirements in the local market.
Australian Wholesalers may need to start the journey of ‘future-proofing’ their processes now to remain viable not just in the international marketplace but within Australia should these new standards be picked up at either State or National level.
The old TGA / Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 is available here.
To read more on this topic click here.
Many thanks Kathy,
Any comment / changes to the facilitities themselves (esp. arround temp and humidity control?)
Specific changes would depend on the design of the facility – you would need to do a gap assessment for individual site requirements against the new PIC/S Code of GDP. However, in general, you would need to demonstrate temp/humidity control of storage areas – this often requires a temperature mapping study to determine areas that may not be within the appropriate temp range, and then a validation exercise to ensure that any new/changes to temperature monitoring and control are fit for purpose. This may also be required in secure areas or vaults that are designed for GHIV but the design did not consider the storage temperature requirements. The current Australia GDP does have similar requirements for temperature store validation, however the new PIC/S GDP tightens the documentation and general compliance controls across the facility.