Common use of Non-Conformance Clause in Contracts

Non-Conformance. 11.2.1 Additional Material or Product that do not meet established Specifications shall be handled as Non-conformities and documented as such, in accordance with Strakan’s or its Contract Manufacturer’s standard operating procedures. Actions taken to investigate Non-conformity and to justify the release of the Lot of Product or Batch shall be fully documented. 11.2.2 Aptalis and Strakan shall approve the Non-conformity document as stated below prior to initial release. Any resulting corrective actions shall be followed through timely closure. * Confidential treatment requested. Non-conformance Approval Requirements API Aptalis and Strakan excipient Strakan Product Aptalis and Strakan primary packaging Additional Material manufacturer Aptalis and Strakan printed packaging Additional Material Aptalis and Strakan