16. Radioactive products should be manufactured in controlled New clause, but comments are identical in intent None Nil (environmental and radioactive) trial. All manufacturing steps should to those in PE009-8 Annex 3 clause 2: take place in self-contained facilities dedicated to products should be stored, “Radioactive radiopharmaceuticals. processed, packaged and controlled in dedicated and self-contained facilities. Equipment used for manufacturing operations should be reserved for radiopharmaceuticals.” The requirements for controlled environments echo those outlined in existing clause 3.12. 17. Measures should be established and implemented to prevent New clause, but comments are identical in intent Specific Minor from personnel, materials, radionuclides etc. Closed or to those in PE009-8 clauses 5.18-5.19. requirement for contained equipment should be used whenever appropriate. Where Risk assessment open equipment is used, or equipment is opened, precautions should to justify be taken to minimize the risk of contamination. The risk assessment environmental should demonstrate that the environmental cleanliness level proposed control used for is suitable for the type of product being manufactured. manufacture. This is in line with existing QRM principles, and is not an additional requirement. 18. Access to the manufacturing should be via a gowning area New clause, but comments are identical in intent This statement Minor and should be restricted to authorised personnel. to those in PE009-8 clauses 3.5, 3.7, 3.31 & 5.16. specifically mentions the use of separate gowning areas
16. Radioactive products should be manufactured in controlled (environmental and radioactive) All manufacturing steps should take place in self-contained facilities dedicated to radiopharmaceuticals. New clause, but comments are identical in intent to those in PE009-8 Annex 3 clause 2: “Radioactive products should be stored, processed, packaged and controlled in dedicated and self-contained facilities. Equipment used for manufacturing operations should be reserved for radiopharmaceuticals.” The requirements for controlled environments echo those outlined in existing clause 3.12. None Nil 17. Measures should be established and implemented to prevent from personnel, materials, radionuclides etc. Closed or contained equipment should be used whenever appropriate. Where open equipment is used, or equipment is opened, precautions should be taken to minimize the risk of contamination. The risk assessment should demonstrate that the environmental cleanliness level proposed is suitable for the type of product being manufactured. New clause, but comments are identical in intent to those in PE009-8 clauses 5.18-5.19. Specific requirement for Risk assessment to justify environmental control used for manufacture. This is in line with existing QRM principles, and is not an additional requirement. Minor 18. Access to the manufacturing should be via a gowning area and should be restricted to authorised personnel. New clause, but comments are identical in intent to those in PE009-8 clauses 3.5, 3.7, 3.31 & 5.16. This statement specifically mentions the use of separate gowning areas Minor trial.
consult-manuf-automatic-adoption-pics-130529-comparison.docx