Quality Assurance Key Elements Clause Samples

Quality Assurance Key Elements. OSGP acknowledges and guarantees that it will operate in strict compliance with the applicable cGMP's. In addition, OSGP agrees to comply with P&GP SARL Quality Standards as described in P&GP SARL's Quality Assurance Key Elements (QAKE) Assessment and all future revisions thereto. P&GP SARL shall use said QAKE Assessment periodically to audit OSGP's Norwich Plant and shall provide OSGP a written report following said audit. For all Products that OSGP produces for P&GP SARL and all facilities and systems supporting such production, should OSGP's audit result in a score less than 100%, OSGP shall develop and implement, and P&GP SARL shall approve in writing, a detailed plan to improve OSGP's systems. P&GP SARL will provide a copy of the QAKE manual to OSGP, which shall be incorporated as appropriate into OSGP's operating procedures used for production of Products covered by this Agreement. Should OSGP fail to meet the agreed-upon success criteria on a mutually acceptable time schedule, or fall below a QAKE score of 85%, P&GP SARL shall have the right to notify OSGP of their failure to perform per Article 8.

Quality Assurance Key Elements. NOVEN represents and warrants that NOVEN’s quality control systems are designed to meet the quality standards described in Exhibit A hereto (referred to as “Quality Assurance Key Elements Assessment” or “QAKE”), to the extent such standards are applicable to the Services performed by NOVEN hereunder. In connection with its Annual MA conducted under the Quality Assurance Agreement, with respect to compliance with QAKE, P&GP may audit NOVEN’s manufacturing facility, in a manner not to unreasonably interfere with NOVEN’s operation at the manufacturing facility. P&GP will provide to NOVEN such results from the QAKE audit in the form of a score. If the score is less than ***, NOVEN shall develop and implement a detailed action plan to improve NOVEN’s quality standards. In the event NOVEN fails to implement such action plan or subsequent audit results have a score of less than ***, P&GP shall be entitled to a review of all batch documentation and/or on site monitoring of process conditions prior to the shipment of Product to P&GP, subject to the parties reaching mutual agreement with respect to the payment of costs and expenses associated with such monitoring. It is acknowledged that nothing in this Section 3.11 shall limit NOVEN’s representations and warranties set forth in Section 8.01(a), including NOVEN’s representations and warranties regarding compliance with cGMP.