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.
| Clause(s) | Page* | Interpretation |
|---|---|---|
| Chapter 1 - Principle | 1 | Comply with marketing authorisation requirements |
| 1.4xv, 1.9vii | 3, 5 | |
| 1.9ii | 5 | |
| 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
| 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 | |
| Annex 13 | 99 | Investigational medicinal product manufacture |
| Annex 19 | 149 | Reference samples |
*: Page in the Annexes of the PIC/S guide to GMP