34. Production of different radioactive products in the same working 6. Production of different radioactive products None Nil area (i.e. hot-cell, LAF unit), at the same time should be avoided in in the same work stations and at the same time order to minimise the risk of cross-contamination or mix-up. should be avoided in order to minimise the risk of cross contamination or mix-up. 35. Special attention should be paid to validation including validation None Nil New clause, but comments are identical in intent of computerised systems which should be carried out in accordance in to in PE009-8 clause 5.21-5.24 and Annex compliance PIC/S GMP Guide, Annex 11. New manufacturing 11. processes should be validated prospectively. 36. The critical parameters should normally be identified before or New clause, but comments are identical in intent Approach to Nil during validation and the ranges necessary for reproducible operation to those in PE009-8 Annex 15 clauses 24-25. validation is should be defined. similar to the QBD principle, however, manufacturers with good sound validation principles should not be challenged by this clause. 37. Integrity testing of the membrane filter should be performed for New clause, but comments are identical in intent None Nil aseptically filled products, taking into account the need for radiation to those in PE009-8 Annex 1 clause 113. protection and maintenance of filter sterility. 38. Due to radiation exposure it is accepted that most of the labelling New clause no equivalent in This clause Nil – of the direct container, is done prior to manufacturing. Sterile empty outlines the closed vials may be labelled with partial information prior to filling practical
34. Production of different radioactive products in the same working area (i.e. hot-cell, LAF unit), at the same time should be avoided in order to minimise the risk of cross-contamination or mix-up. 6. Production of different radioactive products in the same work stations and at the same time should be avoided in order to minimise the risk of cross contamination or mix-up. None Nil 35. Special attention should be paid to validation including validation of computerised systems which should be carried out in accordance in compliance PIC/S GMP Guide, Annex 11. New manufacturing processes should be validated prospectively. New clause, but comments are identical in intent to in PE009-8 clause 5.21-5.24 and Annex 11. None Nil 36. The critical parameters should normally be identified before or during validation and the ranges necessary for reproducible operation should be defined. New clause, but comments are identical in intent to those in PE009-8 Annex 15 clauses 24-25. Approach to validation is similar to the QBD principle, however, manufacturers with good sound validation principles should not be challenged by this clause. Nil 37. Integrity testing of the membrane filter should be performed for aseptically filled products, taking into account the need for radiation protection and maintenance of filter sterility. New clause, but comments are identical in intent to those in PE009-8 Annex 1 clause 113. None Nil 38. Due to radiation exposure it is accepted that most of the labelling of the direct container, is done prior to manufacturing. Sterile empty closed vials may be labelled with partial information prior to filling New clause – no equivalent in This clause outlines the practical Nil
consult-manuf-automatic-adoption-pics-130529-comparison.docx