Nonconformances Sample Clauses
Nonconformances. Supplier must notify the Buyer of non-conforming material/product. Supplier must make arrangements approval of supplier non-conforming material.
Nonconformances. A. Control of nonconforming articles.
B. Control of nonconforming product.
C. Rework of nonconforming product.
Nonconformances. Processing Product Changes
Nonconformances. Material or product not meeting established specifications are to be handled as nonconformances and documented as such, based on ▇▇▇▇▇▇ LABORATORIES standard procedures. Actions taken to investigate the nonconformance and to justify the release of the lot of material must be fully documented. The nonconformance document (i.e., NCMR) will be approved by both ▇▇▇▇▇▇ LABORATORIES and [TP NAME] as stated below. The approved document will become the specification for the release of that specific lot of material. Any resulting corrective actions shall be followed through to timely closure. Approval by the appropriate Quality Assurance functions are solicited and obtained via facsimile copy. ------------------------------------------------------------------ Nonconformance Approval Requirements ------------------------------------------------------------------ Finished Product [TP NAME] and ▇▇▇▇▇▇ LABORATORIES ------------------------------------------------------------------ Raw Materials sourced and used ▇▇▇▇▇▇ LABORATORIES. by ▇▇▇▇▇▇ LABORATORIES ------------------------------------------------------------------ Drug Substance and Raw Materials [TP NAME] and ABBOTT sourced by [TP NAME] to be used LABORATORIES by ▇▇▇▇▇▇ LABORATORIES. ------------------------------------------------------------------ **Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission. [GRAPHIC OMITTED] ▇▇▇▇▇▇ LABORATORIES PHARMACEUTICAL PRODUCTS DIVISION GENERAL PRACTICE PAGE 40 DOCUMENT GP.0074 -------------------------------------------------------------------------------- ISSUE DATE SUPERCEDES 05/08/2000 07/15/1999 -------------------------------------------------------------------------------- ATTACHMENT A-3 (Cont.)