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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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Pharmaceutical quality system (PQS)

The principle of the pharmaceutical quality system (PQS), formerly called Quality Management System (QMS), is to ensure medicinal products are:

  • fit for their intended use
  • comply with relevant authorisation requirements
  • do not place patients at risk due to inadequate safety, quality or efficacy

To comply, your PQS should incorporate GMP and Quality Risk Management (QRM) principles and be:

  • designed comprehensively
  • documented fully
  • implemented correctly
  • monitored for effectiveness
  • adequately resourced and fully supported by senior management

Marketing Authorisation

Where an applicable Marketing Authorisation (MA) is in place, manufacture the goods in full accordance with the conditions of the MA. (Part I, Chapter 1, Principle).

Where there is no Marketing Authorisation, e.g. where the product is exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG), the product formulation should be in line with the formally received clinician order and any default standards relevant to the production of the medicine.

Order management

Orders can be received in any format (phone/fax/email), but normally in written form (including a prescription), with the order then used as part of the final release check. Any changes made to the order should follow an established process to ensure appropriate documentation and approval of any change to avoid any mix-up.

If the order is not clear enough, then it should be clarified with the customer.

  • For products supplied under Schedule 5A, Item 5 of the Therapeutic Goods Regulations 1990, the manufacturer should be aware of the specific conditions of supply, and is required to ensure that the product is not substantially similar to a product that is available commercially.
  • For orders for products supplied under Schedule 5, Item 6 of the Therapeutic Goods Regulations 1990, the manufacturer should ensure that a specific patient(s) is identified within the order.

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