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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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Interpretation of the basic GMP requirements

The tables below reference the section in this guidance that refers to a particular clause or Annex. Only the clauses and annexes with a specific interpretation for manufacture of sterile radiopharmaceuticals labelled with fluorine-18 are listed in the tables.

Interpretation of PE009-13 Part I
Clause(s) Page* Interpretation
Chapter 1 - Principle 1 Comply with marketing authorisation requirements
1.4xv, 1.9vii 3, 5

Release for supply

Procedure for release for supply

1.9ii 5

Radioactive starting material

Non-radioactive starting material

1.9viii 5 Reference samples
2.5, 2.9 9 – 10 Separate testing and release person
3.22 15 Sampling areas for starting materials
4.17(d), 5.39 21, 29 Product yield
5.30 29 Starting material collection and testing
5.58 31 Release for supply
5.61 32 Rejected and waste materials

*: Page in Part 1 of the PIC/S guide to GMP

Interpretation of PE009-13 annexes
Clause(s) Page* Interpretation
Annex 1 - Principle 1 Sterility
Annex 1.9 3 Monitoring of clean air device and clean rooms
Annex 1.21 5 Isolator technology
Annex 1.66 11 Media fills
Annex 1.80 12 Bioburden monitoring
Annex 1.113 16 Filter integrity tests
Annex 1.119 17 Crimping vial caps
Annex 1.124 17 Visual inspection
Annex 1.125-1.127 17 Sterility testing
Annex 1.125-1.127 17, 18 Endotoxin testing
Annex 3.18 48 Entry to clean areas
Annex 3.27 49 Isolator technology
Annex 3.33 50 Retention of documentation
Annex 8.3 82

Synthesis kits

Validation of starting materials

Annex 13 99 Investigational medicinal product manufacture
Annex 19 149 Reference samples

*: Page in the Annexes of the PIC/S guide to GMP

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