Methods Validation Sample Clauses

Methods Validation. 2. Accelerated stabilities on development batches
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Methods Validation. 5.9.1 ORPHAN is responsible for providing to LONZA approved copies of the most current and complete filed analytical methods relating to the PRODUCT for receipt of API and raw materials, in-process product testing, product lot release, and drug and product stability and cleaning validation.
Methods Validation. Genchem Pharma shall cause Sicor to validate Anthra's regulatory methods for ***, as set forth in the CMCs for the United States and the European Union, and shall cause Sicor to use such assays as the basis for all AD32 release and stability testing.
Methods Validation. For those analytical methods to be provided by XANODYNE, XANODYNE shall be responsible for providing to DSM approved copies of the current and complete regulatory filed analytical methods and supporting validation documentation relating to the Products, for application by DSM in the production process, including receipt of API and raw materials, in-process product testing, product batch release, drug and product stability, and cleaning validation.
Methods Validation. For those analytical methods to be provided by AMAG, AMAG shall be responsible for providing to DPI approved copies of the current and complete regulatory filed analytical methods and supporting validation documentation relating to the Products for application by DPI in the production process, including receipt of API and raw materials, in-process product testing, product batch release, drug and product stability, and cleaning validation.

Related to Methods Validation

  • Validation ‌ Within one (1) year after the effective date of this contract, the Agency shall submit this contract to a court of competent jurisdiction for determination of its validity by a proceeding in mandamus or other appropriate proceeding or action, which proceeding or action shall be diligently prosecuted to final decree or judgment. In the event that this contract is determined to be invalid by such final decree or judgment, the State shall make all reasonable efforts to obtain validating legislation at the next session of the Legislature empowered to consider such legislation, and within six (6) months after the close of such session, if such legislation shall have been enacted, the Agency shall submit this contract to a court of competent jurisdiction for redetermination of its validity by appropriate proceeding or action, which proceeding or action shall be diligently prosecuted to final decree or judgment.

  • Validation Mechanism To be eligible for articulation, the student must show evidence of their CompTIA A+ certification and it must have been issued within three (3) years prior to their enrollment in the program.

  • Validation Review In the event OIG has reason to believe that: (a) Good Shepherd’s Claims Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the Claims Review complied with the requirements of the CIA and/or the findings or Claims Review results are inaccurate (Validation Review). Good Shepherd shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Good Shepherd’s final Annual Report shall be initiated no later than one year after Good Shepherd’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Good Shepherd of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Good Shepherd may request a meeting with OIG to: (a) discuss the results of any Claims Review submissions or findings; (b) present any additional information to clarify the results of the Claims Review or to correct the inaccuracy of the Claims Review; and/or (c) propose alternatives to the proposed Validation Review. Good Shepherd agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any Claims Review issues with Good Shepherd prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG.

  • Architecture The Private Improvements shall have architectural features, detailing, and design elements in accordance with the Project Schematic Drawings. All accessory screening walls or fences, if necessary, shall use similar primary material, color, and detailing as on the Private Improvements.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Processes Any employer, employee, trade union or employer’s association may at any point in time apply for an exemption from any of the provisions of this Collective Agreement. The applicant is required to complete and submit in writing with the relevant office of the Council, a fully and properly completed prescribed application for exemption form, accompanied by all relevant supporting documentation.

  • Methods i. Brief description of the method used.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Traceability 11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.

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