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Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Interpretation of the PIC/S guide to GMP

11 February 2019

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Outsourced activities

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.

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