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Medicinal gases guidance

Version 2.0, January 2019

15 January 2019

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Outsourced activities (Chapter 7)

Examples of outsourced activities include, but are not limited to:

  • contract manufacturing and analysis
  • equipment maintenance and calibration services
  • cylinder maintenance or testing facilities
  • suppliers and manufacturers of raw materials, packaging materials and printed artwork
  • provision of training and consulting services
  • validation services associated with facilities, equipment, utilities, process and product design, qualification and validation
  • provision of transport and logistical services for products (prior to release for supply)
  • agencies that provide temporary or contract personnel

The title of chapter 7 has changed from 'Contract manufacturer and analysis' to 'Outsourced activities' in recognition of the fact that there are a number of outsourced (contracted) activities that may have a direct effect on the quality of medicinal product manufactured by a site. The previous title of the chapter restricted the extent of GMP controls to only outsourced manufacturing and testing services and thus did not appropriately manage the risk associated with other outsourced activities.

Managing outsourced activities

TGA expect manufacturers (normally 'contract givers') to:

Legality of outsourced activities

The term 'legality' in clause 7.4.1 means that contract givers are responsible for making sure that the entity undertaking the outsourced activities is appropriately authorised to undertake the activity. This may be achieved by many means including ensuring that the contract acceptor:

Monitoring the contract acceptor

The contract giver should have a system in place to measure and monitor the quality of products (or service) provided by the contract acceptor, in accordance with risk management principles.

Where quality related issues are identified, it is expected that appropriate actions are taken to address and remediate the concerns.

Records of actions taken should be recorded within the PQS.

Responsibility for review of records and results

Clause 7.5 states that the contract giver should be responsible for reviewing and assessing the records and the results related to the outsourced activities.

It is expected that the responsibility for review of the records and results to be specified by the contract should be based on the risk and nature of the service provided. For example:

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