(b) Stability protocol for Commitment batches (e.g. storage conditions (including tolerances), batch numbers (if known) and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): (c) Stability protocol for Ongoing Batches (e.g. storage conditions (including tolerances), number of batches per strength and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): Details Parameter Storage % RH) condition(s) (◦C, Batch size(s), annual allocation <at least one production batch per year (unless none is produced that year) in each container closure system > Tests and acceptance criteria Description Moisture Impurities Assay etc. Testing frequency Container closure system(s) 2.3.P.8.3 Stability Data (c) Bracketing and matrixing design for commitment and/or continuing (i.e. ongoing) batches, if applicable: WRITTEN COMMITMENTS OF THE MANUFACTURER WHO – Important note: The product information is an essential part of the medicinal product. The SmPC and PIL
(b) Stability protocol for Commitment batches (e.g. storage conditions (including tolerances), batch numbers (if known) and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): (c) Stability protocol for Ongoing Batches (e.g. storage conditions (including tolerances), number of batches per strength and batch sizes, tests and acceptance criteria, testing frequency, container closure system(s)): Parameter Details Storage condition(s) (◦C, % RH) Batch size(s), annual allocation <at least one production batch per year (unless none is produced that year) in each container closure system > Tests and acceptance criteria Description Moisture Impurities Assay etc. Testing frequency Container closure system(s) 2.3.P.8.3 Stability Data (c) Bracketing and matrixing design for commitment and/or continuing (i.e. ongoing) batches, if applicable: WRITTEN COMMITMENTS OF THE MANUFACTURER – WHO Important note: The product information is an essential part of the medicinal product. The SmPC and PIL
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