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PE009-13, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
Outsourced activities (Chapter 7)
Change in scope of chapter 7
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.
Examples of outsourced activities that this chapter would now apply to include, but are not limited to:
- contract manufacturing and analysis
- maintenance and calibration services
- providers of critical consumables, e.g. gowns, sterilised componentry
- 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
- contract cleaning and waste management services
- contract pest control services
- agencies that provide temporary or contract personnel
Managing outsourced activities
TGA expect manufacturers (normally 'contract givers') to manage all relationships with contract acceptors in accordance with existing principles of chapter 7. All outsourced GMP-related activities that may impact on product quality should be assessed, defined and covered by a written contract. Agreements should be maintained in accordance with the Pharmaceutical Quality System.
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:
- holds the appropriate manufacturing authorisation (licence) to undertake the specific steps in manufacture;
- is nominated as being authorised to undertake the specific activity in the specific marketing authorisation of the products;
- holds any necessary licenses or permits applicable to the outsourced activities, e.g. wholesale authorisations, Schedule 8 drugs permits etc.
- holds the necessary accreditation related to the activities undertaken, e.g. a contract calibration company may hold NATA or ISO 17025 certification
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 contract and should be based on the risk and nature of the service provided e.g.:
- For contract manufacture and analysis it may be appropriate for the contract giver to rely fully on the contract acceptor where an authorised representative of the contract acceptor, e.g. quality manager, has authorised the data and records.
- For contract service providers (e.g. contract calibration services) it would be appropriate for the contract giver to review the available records and data to ensure that the results or work provided meet the requirements of the contract giver's quality system and procedures.