described in the Supplement on Sterile environment. Products. This may be achieved by the This is a change provision within the work station of a laminar from existing flow of HEPA-filtered air and by fitting air-locks requirement of to entry ports. Total containment work stations grade D. Would may provide these requirements. They should require some be in an environment conforming to at least manufacturers to grade D.” upgrade their manufacturing environments which may invoke additional costs for operation, gowning and monitoring. 28. Prior to the start of manufacturing, assembly of sterilised New clause, but comments are similar in intent None Nil equipment and consumables (tubing, sterilised filters and sterile to those in PE009-8 Annex 1 clause 31: Only closed and sealed vials to a sealed fluid path) must be performed applies to sterile medicines. under aseptic conditions. 29. All documents related to the manufacture of radiopharmaceuticals New clause, but comments are identical in intent None Nil should be prepared, reviewed, approved and distributed according to to those in PE009-8 Chapter 4. written procedures. 30. Specifications should be established and documented for raw New clause, but comments are identical in intent None Nil materials, labelling and packaging materials, critical intermediates and to trial in PE009-8 clause 4.10. the finished radiopharmaceutical. Specifications should also be in for any other critical items used in the manufacturing process, such as
described in the Supplement on Sterile Products. This may be achieved by the provision within the work station of a laminar flow of HEPA-filtered air and by fitting air-locks to entry ports. Total containment work stations may provide these requirements. They should be in an environment conforming to at least grade D.” environment. This is a change from existing requirement of grade D. Would require some manufacturers to upgrade their manufacturing environments which may invoke additional costs for operation, gowning and monitoring. 28. Prior to the start of manufacturing, assembly of sterilised equipment and consumables (tubing, sterilised filters and sterile closed and sealed vials to a sealed fluid path) must be performed under aseptic conditions. New clause, but comments are similar in intent to those in PE009-8 Annex 1 clause 31: Only applies to sterile medicines. None Nil 29. All documents related to the manufacture of radiopharmaceuticals should be prepared, reviewed, approved and distributed according to written procedures. New clause, but comments are identical in intent to those in PE009-8 Chapter 4. None Nil 30. Specifications should be established and documented for raw materials, labelling and packaging materials, critical intermediates and the finished radiopharmaceutical. Specifications should also be in for any other critical items used in the manufacturing process, such as New clause, but comments are identical in intent to in PE009-8 clause 4.10. None Nil trial