Stability Studies and Protocol Clause Samples
Stability Studies and Protocol. The Client will develop and validate stability indicating assay(s) before process validation. If required, Patheon may assist at Client’s cost. If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Patheon will give the Client the stability data on an ongoing basis as agreed to by both parties.
Stability Studies and Protocol. CPI will conduct stability studies to support the retest period and/or expiration date listed in CPI’s certificate of analysis and in accordance with the validated stability testing analytical methods in accordance with the approved stability protocol. CPI will analyze stability samples in a timely manner in accordance with cGMP and SOPs, and, prior to the DMF Approval, shall give the Regulatory Consultant the stability summary report within thirty (30) days of the approved stability testing at each time point.
Stability Studies and Protocol. MDCO will develop and validate stability indicating assay(s) prior to process validation. If required, Patheon may assist, with the cost being borne by MDCO. Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical methods at the agreed upon testing points in accordance with the approved stability protocol. Patheon will perform the stability testing described in accordance with the stability protocol developed by MDCO. Stability data will be provided by Patheon to MDCO on an ongoing basis as agreed to by both parties.
Stability Studies and Protocol. Stability Studies will be conducted in accordance with the MSA or the Technology Transfer Agreement, as applicable.