information to the clinical coordinator or equivalent if required. 47. A system to verify the quality of starting materials should be in New clause, but comments are identical in intent None Nil place. Supplier approval should include an evaluation that provides to in PE009-clauses 8 5.25 & 5.26. adequate assurance that the material consistently meets Complements PE009-10 Annex 3 clause 30 specifications. The starting materials, packaging materials and critical process aids should be purchased from approved suppliers. 48. For radiopharmaceuticals sufficient samples of each batch of bulk Annex 3 clause 9 PE009-8 otherwise The retention Minor “Unless formulated product should be retained for at least six months after specified in the marketing authorisation, period for expiry of the finished medicinal product unless otherwise justified reference samples of every batch should be through risk management. retained.” is shorter than that for non New clause, but comments are identical in intent radio materials to those in PE009-8 Annex 19 clause 2.2 & 3.1 – (12 months past 3.2. expiry). Clause allows risk management to determine whether any bulk retain sample will be kept. Manufacturer will have to possibly devise risk assessments and amend
information to the clinical coordinator or equivalent if required. 47. A system to verify the quality of starting materials should be in place. Supplier approval should include an evaluation that provides adequate assurance that the material consistently meets specifications. The starting materials, packaging materials and critical process aids should be purchased from approved suppliers. New clause, but comments are identical in intent to in PE009-clauses 8 5.25 & 5.26. Complements PE009-10 Annex 3 clause 30 None Nil 48. For radiopharmaceuticals sufficient samples of each batch of bulk formulated product should be retained for at least six months after expiry of the finished medicinal product unless otherwise justified through risk management. Annex 3 clause 9 PE009-8 “Unless otherwise specified in the marketing authorisation, reference samples of every batch should be retained.” New clause, but comments are identical in intent to those in PE009-8 Annex 19 clause 2.2 & 3.1 – 3.2. The retention period for is shorter than that for non radio materials (12 months past expiry). Clause allows risk management to determine whether any bulk retain sample will be kept. Manufacturer will have to possibly devise risk assessments and amend Minor
consult-manuf-automatic-adoption-pics-130529-comparison.docx