definiens: shall mean Manufacturing documentation, packaging documentation, and exception documentation, such as a non - conformance report, Deviation Report and Certificate of Analysis, and additional documentation, whichmay have been processed as part of the production and packaging records of the Batch ; shall mean any Product, which has completed all Manufacturing stages up to, but not includingpackaging in a primary container ; is a temporary modification or exception to usual operating, Manufacturing, packaging, testinginstructions, test results or procedures ; shall mean a report used to obtain approvals to temporarily modify or to document exceptions tousual operating, Manufacturing, packaging, testing instructions, test results or procedures . A Deviation Report doesnot permanently change existing instructions or standard operation procedures, it is intended to be a specific, document ; shall have the meaning given in Section 7.1 ; shall have the meaning given in Section 7.2 ; shall have the meaning given in the Supply Agreement ; shall mean the quality of the Product described in Appendix 4 ; shall mean a visual or mechanical evaluation performed to remove / correct defective units and forwhich the process is not expected to have an adverse effect on product quality . Reinspection shall involve the use ofa Deviation, except where standard procedure allows for such routine activity in the course of normal processing ; shall mean reprocessing all or part of a Lot of a Bulk Product or Product to a previous step in theManufacturing Process due to a failure to meet the Specifications for such Bulk Product or Product . Reprocessingprocedures are foreseen as occasionally necessary and pre - approved by the quality assurance departments ofStrakan and Aptalis ; and shall mean reworking a Bulk Product or Product of a single Lot that failed to meet predeterminedSpecifications using an alternative Manufacturing Process . Reworking is an unexpected occurrence and rework mustbe pre - approved by [COMPANY] and Aptalis and documented per approved Rework documentation requirements andappended to a Deviation Report