Full compliance with chapter 7 requirements is expected. All outsourced GMP-related activities that may impact on product quality should be assessed, defined and covered by a written contract.
Examples of outsourced activities 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
Contracts should be in place between the site of manufacture and the entity receiving the goods, e.g. private hospital, public hospital, public institution, clinician, medical imaging centre, etc.
