Deviation Reports. TVA shall report all deviations from the requirements of the Compliance Agreement that occur during the calendar year covered by the annual report, identifying the date and time that the deviation occurred, the date and time the deviation was corrected, the cause of any corrective actions taken for each deviation, if necessary, and the date that the deviation was initially reported under Paragraph 156.
Deviation Reports. If during the manufacture or other handling of Product by Adolor (a) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (b) there is reasonable evidence that Specifications or cGMPs were not followed in production of the Products, (c) there is reasonable evidence that the Products fail to conform to Specifications, (d) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) which could reasonably be expected to adversely affect the quality of the Products or otherwise are unusual or not expected, or (e) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by a person with appropriate technical knowledge and experience exercising his best professional judgment, then Adolor shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to GSK. Adolor shall include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.
Deviation Reports. If during the manufacture or other handling of a Final Product by GLAXO, (i) the process or analytical limits vary from the typical or established report ranges, release guidelines, or release limits, (ii) Specifications or cGMPs were not followed in the production of the Products, or (iii) the Products fail to conform to Specifications, then LGLS shall provide to GS, or cause GLAXO to provide to GS, the written report detailing such deviation (“Deviation Report”) prepared by GLAXO, along with all supporting documentation. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records. Any batch or shipment of Final Product that is the subject of a nonconformity or a Deviation Report shall not be shipped to GS, unless otherwise directed by GS, or, if such Final Product was shipped and is held in stock by GS, then it shall be given a “Hold” or “Unpassed” status and shall not be released into the passed inventory of GS until GS has completed any investigations related to such Products and approved the disposition of the Final Product. GS shall provide written instructions to LGLS regarding the destruction of any nonconforming Final Products. The cost of destruction and the replacement cost of Final Product *****.
Deviation Reports. If, during the Manufacture or other handling of a Product by Impax, (i) the process or analytical parameters vary from typical or established report ranges, release guidelines or release limits, (ii) there is reasonable evidence that Specifications, the Quality Agreement, cGMPs or Laws were not followed in production of the Products, (iii) there is reasonable evidence that the Products fail to conform to Specifications, (iv) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) that could reasonably be expected to adversely affect the strength, safety, identity, purity and quality of the Products or otherwise are unusual or not expected, or (v) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by an individual with appropriate technical knowledge and experience exercising his or her best professional judgment, then Impax shall investigate the matter pursuant to provisions of the Quality Agreement and this Supply Agreement and, only if such matter is a Critical Deviation or Major Deviation (as such terms are defined in the Quality Agreement), prepare as soon as practicable following the discovery of such Critical Deviation or Major Deviation a written report detailing such Critical Deviation or Major Deviation (a “Deviation Report”) and send such Deviation Report, along with all supporting documentation, to GSK prior to the shipment of the Product. Impax shall include in its Deviation Report its analysis and recommendation for the disposition of the Product in the Deviation Report.
Deviation Reports. If during the manufacture or other handling of a Product by Draxis (i) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (ii) there is reasonable evidence that Specifications, cGMPs or GSK Group Quality Polices were not followed in production of the Products, (iii) there is reasonable evidence that the Products fail to conform to Specifications, (iv) other events or conditions occur which could reasonably be expected to adversely affect the quality of the Products or otherwise are unusual or not expected, or (v) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by a person with appropriate technical knowledge and experience exercising his best professional judgment, then Draxis shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to GSK. Draxis shall include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.
Deviation Reports. If during the manufacture or other handling of a Product by Supplier (i) the process or tested Product limits and quality measurements vary from typical or established report ranges, release guidelines or release limits, (ii) Specifications were not followed in production of the Products, or (iii) the Products fail to conform to Specifications, then Supplier shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to NCR and to all Designated Purchasers.
