Packaging Instructions Deviations Sample Clauses

Packaging Instructions Deviations. Patheon will document, investigate, and resolve any deviation from approved packaging instructions or Specifications according to Patheon SOP’s. Patheon will report and obtain approval from the Client’s responsible person for DR type deviations where there is a potential to affect Product quality. Such Client approval will not be unreasonably withheld. Patheon will provide copies of all DR’s to the Client as part of the executed batch packaging record.

Packaging Instructions Deviations. Patheon will document, investigate, and resolve any deviation from approved packaging instructions or Specifications according to Patheon SOPs. Patheon will report and obtain approval from the Client’s responsible person for DR type deviations where there is a potential to affect Product quality. Patheon will give the Client copies of all DR’s as part of the executed batch packaging record. (i) Final Disposition of the Product batch will be the sole responsibility of the Client. (ii) Patheon will notify the Client immediately if it is identified that a batch previously shipped to the Client is impacted by a quality decision. Patheon will cooperate fully with the investigation, supplying needed information as required. (iii) In the event that a dispute arises between the Client and Patheon in the nonconformity of a batch of Product, resolution of the dispute will be governed by the terms of the MSA and Product Agreement. (iv) It is the responsibility of Patheon to ensure that all deviations are investigated, documented, and approved within thirty (30) days. If the deviation investigation requires more than thirty (30) days for completion, an interim report will be prepared by Patheon to provide reasons for the delay and to specify planned investigation activities and timelines for completion. Patheon will provide a copy of the final report to the Client.