Certificate of Analysis definition
Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.
Certificate of Analysis means a document prepared by Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results.
Certificate of Analysis means the report prepared for the requester about the analytical testing performed and the results obtained by a laboratory.
Examples of Certificate of Analysis in a sentence
On Delivery, Supplier shall provide to Purchaser a Batch Certificate and a Certificate of Analysis for the Drug Product Delivered or a Certificate of Analysis for the Commercial API Delivered, as applicable, and any other documentation required to be provided on Delivery as expressly set forth in the Quality Agreement or as mutually agreed by the Parties from time to time.
More Definitions of Certificate of Analysis
Certificate of Analysis means the document identifying the results of the Methods of Analysis for a specific Batch of Product in a form agreed to by the Parties in writing but which shall include, without limitation, the applicable Product Batch’s manufacturing date, expiration date, lot number and testing results and data.
Certificate of Analysis. (COA) means a document produced by a testing laboratory listing the quantities of the various analytes for which testing was performed.
Certificate of Analysis has the meaning set forth in the Quality Agreement.
Certificate of Analysis means a certificate of analysis that certifies that a Batch meets the release Specifications.
Certificate of Analysis means a written certificate listing the items tested, Manufacturer, specifications, testing methods and test results for a specific Batch.
Certificate of Analysis as to any Batch of Product, means a certificate attesting to the results of testing of such Batch of Product against the criteria specified in relevant Product Specifications, and including test methods, specification parameters and the pass/fail criteria, used to show that a particular Batch of such Product meets Product Specifications, and a statement attesting that a particular Batch of a Product was Manufactured in accordance with cGMP and the executed Batch Records.
Certificate of Analysis means a certificate of analysis signed and dated by a Corgenix employee qualified and duly authorized to certify that each lot of product released for distribution was manufactured in compliance with approved procedures and that all specifications have been met. The specifications and the results obtained with the lot of product being certified shall be included on the certificate. An example of a Certificate of Analysis is shown in Exhibit B, but the exact contents and format will be modified to reflect final product specifications.