Notification of Deviations. Patheon will notify the Client within one Business Day if any significant deviation occurs during manufacture, testing or storage of the Product, where the deviation affects the quality, efficacy or availability of the Product.
Notification of Deviations. Patheon will notify Cangene within [**] of discovery if any significant deviation occurs during manufacture of the Product, where such deviation has the potential to affect the quality, efficacy or availability of the Product. If the deviation affects, or could affect, batches already released and distributed, Patheon will notify Cangene within [**] after detecting the deviation. Cangene will provide feedback to Patheon on the investigation report within [**] Calendar days.
Notification of Deviations. Patheon will notify the Client within [***] if any significant deviation occurs during manufacture of the CTM, where such deviation affects the quality, efficacy or availability of the CTM.
Notification of Deviations. Patheon will notify MDCO within one (1) Business Day if any deviation occurs during manufacture of the Product, where such deviation may affect the quality, efficacy or availability of the Product.
Notification of Deviations. Although no deviation from the approved Master Batch Record should occur, any deviation from the process during manufacture must be carefully explained and documented in the batch/lot records, justified and approved by SUPPLIER’S Quality Assurance and production management, and included in the document package. Notification of any process deviations will be forwarded to SUPERNUS Quality Assurance in writing within two (2) BD of the occurrence. SUPERNUS will be provided with documentation for the evaluation of the deviation and SUPERNUS will determine the final disposition of the batch/lot. Completed investigations and deviations must be forwarded to SUPERNUS Quality Assurance by SUPPLIER within two (2) BD of completion, unless involving a failure potentially impacting safety, identity, strength, quality or purity in which case they are to be forwarded immediately upon completion.
Notification of Deviations. Patheon will notify Synageva’s quality unit [**] if any significant deviation occurs during Manufacture of the Product, where such deviation affects the quality, efficacy or availability of the Product. If the deviation affects, or could affect, batches already released and distributed, Patheon will notify Synageva [**] after detecting the deviation. Synageva will provide with a feedback to Patheon on the investigation report within [**].
Notification of Deviations. Bio-Techne shall notify Sponsor within two (2) days in the event of any procedural Deviation from product specification, the requirements of Section 9.3, or test failure for supplied product. Unless otherwise obligated by law or impractical due to requiring an immediate response, such as a spill, Bio-Techne shall consult with Sponsor before taking action in connection with these events.
Notification of Deviations. Patheon will notify the Client within [***] if any significant deviation occurs during manufacture of the Product, where such deviation affects the quality, efficacy or availability of the Product.
Notification of Deviations. During the Processing to produce each Batch, Heraeus shall provide notice to PONIARD of any deviations and nonconformities from the approved Manufacturing Process. The promptness of notification shall be commensurate with the potential impact of the deviation or nonconformance.
Notification of Deviations. Patheon will notify Penwest, via email, within [**] if any deviation occurs during manufacture of the Product.
