Excipient and Active Ingredient Reference Sample. Patheon will keep a reference sample of each material received by Patheon and used to manufacture the Product. The reference sample will consist of at least two times the necessary quantity for all Quality Control tests required to determine whether the materials meet required Specifications. The reference samples will be stored by Patheon under controlled conditions in accordance with GMP storage requirements for one year beyond the expiration date of the last batch of the product containing the materials. The reference samples will be made available by Patheon to the Client, if requested
Appears in 3 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Excipient and Active Ingredient Reference Sample. Patheon will keep a reference sample of each material received by Patheon and used to manufacture the ProductCTM. The reference sample will consist of at least two [***] times the necessary quantity for all Quality Control tests required to determine whether the materials meet required Specificationsspecifications. The reference samples will be stored by Patheon under controlled conditions in accordance with GMP storage requirements for one year [***] beyond the expiration date of the last batch of the product containing the materials. The reference samples will be made available by Patheon to the Client, if requested.
Appears in 2 contracts
Samples: Supply Agreement (Relypsa Inc), Supply Agreement (Relypsa Inc)
Excipient and Active Ingredient Reference Sample. Patheon will keep a reference sample of each material received by Patheon and used to manufacture the Product. The reference sample will consist of at least two times the necessary quantity for all Quality Control tests required to determine whether the materials meet required Specifications. The reference samples will be stored by Patheon under controlled conditions in accordance with GMP cGMP storage requirements for (1) one year beyond the expiration date of the last batch of the product Product containing the materials, or such longer period as may be required by applicable law. The reference samples will be made available by Patheon to the Client, if requested.
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Excipient and Active Ingredient Reference Sample. Patheon will keep a reference sample of each material received by Patheon and used to manufacture the Product. The reference sample will consist of at least two times [***] the necessary quantity for all Quality Control tests required to determine whether the materials meet required Specifications. The reference samples will be stored by Patheon under controlled conditions in accordance with GMP storage requirements for one year [***] beyond the expiration date of the last batch of the product containing the materials. The reference samples will be made available by Patheon to the Client, if requestedthe
Appears in 1 contract