The clauses in Chapter 2 of PE009-13 (including clause 2.1) place particular emphasis on the roles and responsibilities of senior management who have ultimate control over manufacturing facilities and activities. Senior management are accountable for ensuring appropriate resources are available to support the relevant manufacturing activities. Senior management are to define roles, responsibilities, and authorities for key management personnel (part I, clause 2.5).
Personnel involved in the manufacture of sterile radiopharmaceuticals labelled with fluorine-18 should have the appropriate education, training, experience and skills, or any combination of these elements that will ensure that staff can perform assigned duties and functions at an acceptable level. (Part I, clause 2.1)
Adequate microbiology expertise, either on or off site, is needed to support the provision of acceptable quality (including sterility assurance and environmental monitoring programs).
