Qualification Protocol definition

Qualification Protocol. Qualification Protocol" shall mean that Qualification Protocol set forth at Exhibit "E" hereto, as the same may be amended, supplemented or replaced from time to time.
View Source
Qualification Protocol means a document written by the Secondary Source and approved by Transcept which shall include the following: (i) approved Quality Assurance Secondary Site specifications and methods for the Product; (ii) Secondary Source approved Master Batch Manufacturing Record (MBR) for the Product; (iii) in-process specifications and methods for the Product; (iv) a description of the equipment to be used by the Secondary Source for the manufacture of the Product; (v) a stability schedule to test the batches of Product produced under such Qualification Protocol; (vi) a commitment on the part of the Secondary Source to manufacture [***] of Product and to perform stability testing to support the proposed re-test date; (vii) a report written by the Secondary Source and approved by Transcept which supports all of steps (i)-(vi) outlined above.
View Source

Examples of Qualification Protocol in a sentence

  • Installation will be deemed completed when the Installation Qualification Protocol has been executed and a final report is signed off.

  • Catalent will perform the Product qualification, validation and stability services as described in and in accordance with Process Performance Qualification Protocol No. KP2016-144, as separately agreed by the parties.

  • Molecular Medicine Quality Control will execute the approved Assay Qualification Protocol.

  • Upon receipt of a Sponsor assay test method or protocol, Molecular Medicine Quality Assurance will develop an Assay Qualification Protocol.

  • LECSTAR shall prescreen each such consumer who is Warm Transferred from Marketer or who calls LECSTAR through the use of such toll-free telephone number against the qualification criteria in the Qualification Protocol with respect to the Service(s) and Product Package(s) requested by that consumer (thereupon, a "Qualified Customer").