Examples of QC Sample in a sentence
If the third party laboratory determines that such QC Sample meets the Release Criteria, then PCYC shall be deemed to have accepted such Batch, and shall pay for such Batch as set forth in Section 5.2. If the third party laboratory determines that such Product does not meet the Release Criteria, then such Batch shall be deemed rightfully rejected, and PCYC shall have no further obligation under this Agreement with respect to such Batch.
Such notice is to be delivered to Contractor within fifteen (15) days from PCYC's receipt of the QC Sample from the designated carrier.
The ratios of the various types of QA/QC samples utilized in the program from 1 January, 2011 to 31 August, 2012 are given in Table 12.1.Table 12.1 QA/QC Samples Submitted From January, 2011 to August, 2012 QC Category DH Sample Count QC Sample Count Ratio of QC Samples to DH SamplesThe rate of insertion of standards was varied according to whether the samples were from a mineralized zone or not with a standard every 10 samples in mineralization and every 40 samples outside mineralization.
After notice of rejection is given, PCYC shall cooperate with LONZA in establishing the root cause of the rejection and shall deliver to LONZA a sample of the allegedly non-conforming QC Sample for LONZA's evaluation.
LONZA will test each Batch of Product in accordance with the applicable Test Methods and Product Specifications, and shall supply PCYC with a certificate of analysis confirming that such Batch meets the applicable Product Specifications and Packaging Specifications at the time of batch release if practicable, but in any event no later than with shipment of the QC Sample.
PCYC may reject any Batch delivered hereunder that does not conform with the applicable Master Batch Record, LONZA's standard operating procedures, certificate of analysis, Product Specifications or Packaging Specifications, or documentation or process requirements (collectively, the "Release Criteria") based upon PCYC's testing of the QC Sample in accordance with the Test Methods and review of the Released Executed Batch Record.
PCYC may reject any Batch delivered hereunder that does not conform with the applicable Master Batch Record, DOTTIKON's standard operating procedures, certificate of analysis, Product Specifications or Packaging Specifications, or applicable documentation or process requirements (collectively, the "Release Criteria") based upon PCYC's testing of the QC Sample in accordance with the Test Methods and review of the Released Executed Batch Record.
Medarex warrants that (a) each Batch of Antibody delivered hereunder shall have been manufactured in accordance with cGMP and in accordance with the manufacturing procedures described in the master batch records, as may be modified in accordance with the provisions of Section 6.1, and (b) each QC Sample and Batch conforms to the Specifications at the time of delivery pursuant to Section 3.3. This warranty is the only warranty made by Medarex with respect to Antibodies.
Medarex shall not deliver any Batch of Antibody until IDM accepts or is deemed to have accepted the QC Sample in accordance with the provisions of Section 5.3(a), or a third party laboratory reasonably acceptable to both Medarex and IDM determines that a sample of a Batch meets Specifications in accordance with the provisions of Section 5.3(b).
Prior to the shipment of any Batch of Product, DOTTIKON shall provide PCYC with (a) a quality control sample of such Batch as specified in the applicable Product Appendix (the "QC Sample") for the purpose of confirming that such Batch meets the Product Specifications; (b) one copy of the corresponding Released Executed Batch Record, together with written confirmation that such Batch record has been reviewed and approved by DOTTIKON's quality assurance unit; and (c) a certificate of analysis for such Batch.