Master Formula definition

Master Formula means a document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a manufactured product as well as the processing instructions, including the in-process controls;

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Master Formula means the document changed from time to time in accordance with this Agreement and approved by Helix in writing, that defines the manufacturing methods, manufacturing processes, test methods, materials, and other procedures, directions and controls associated with the manufacture and testing of Product. The Master Formula shall also include or be deemed to incorporate by reference, without limitation, such information as raw materials specifications, in process and final Product sampling standards and Product specifications contained in Schedule A and B, equipment and instrumentation specifications and BioVectra’s standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing.

Master Formula means the document approved by Helix or PDL in writing, that defines the manufacturing methods, test methods, materials, and other procedures, directions and controls associated with the manufacture and testing of Product. The Master Formula shall also include or be deemed to incorporate by reference, without limitation, such information as materials specifications, in process and final Product sampling standards and specifications, equipment and instrumentation specifications and CPL’s standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing. Master Packaging Formula / Procedure means the document, approved by Helix or PDL in writing, that defines the filling and packaging methods, test methods, materials, and other procedures, directions and controls associated with the filling, packaging and testing of Product. The Master Packaging Formula / Procedure shall also include or be deemed to incorporate by reference, without limitation, such information as materials specifications, in process and final Product sampling standards, equipment and instrumentation specifications and CPL’s standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing. Non-Conforming Product or non-conforming means Product or similar material that fails to conform to all of the warranties set forth in Section 11.1 or Product or similar material that was manufactured at a time when the CPL Facility failed to conform to the warranties set forth in Section 11.2. Patents shall mean, with respect to an invention, any patent or patent application, and any patent issuing therefrom, together with any extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations and continuations-in-part thereof, and any patent or patent application claiming priority to any application in common with any such patent containing a disclosure substantially similar to any such patent, all to the extent the foregoing contain claims covering such invention.

Examples of Master Formula in a sentence

• In addition, BioVectra shall provide Helix with such information as is reasonably requested in writing by Helix relating to the the Master Formula, the Services performed under this Agreement or other Product-related documentation.

• BioVectra hereby warrants that the BioVectra Facility shall be maintained in accordance with cGMP and in such condition as will allow BioVectra to conduct the Services in compliance with cGMP, all applicable laws, and in conformance with the Master Formula.

• In the event the parties are unable to come to an agreement within 21 days of the date Helix first gave notice to BioVectra under Section 8.1, the matter may be referred by either Party to a mutually acceptable, qualified and independent Third Party laboratory for final determination of conformance of Product to the Master Formula, whose fees shall be paid by the non-prevailing Party.

• BioVectra hereby warrants that it owns or lawfully controls the BioVectra Facility, and that, provided the Master Formula is successfully implemented including the procurement and installation of all required product-specific equipment, and provided no Force Majeure Event shall occur, BioVectra has sufficient manufacturing capacity to enable BioVectra to conduct the Services required by this Agreement.

• The parties acknowledge that BioVectra may develop improvements to the Master Formula or procedure in the course of performing the Services under this Agreement (“Process Improvements”).

• CPL hereby warrants that the CPL Facility shall be maintained in accordance with cGMP and in such condition as will allow CPL to conduct the Services in compliance with cGMP, all applicable laws, and in conformance with the Master Formula.

• In addition, CPL shall provide Helix with such information as is reasonably requested in writing by Helix relating to the Manufacturing Process, the Master Formula, the Master Packaging Formula / Procedure, the CPL Services performed under this Agreement or other Product-related documentation.

• Perform in process testing Perform cleaning verification testing Transfer drug product analytical methods to AR&D Review final batch record and prepare report Validation Batches Prepare and approve Master Formula Monitor manufacturing and packaging of 3 validation batches Perform cleaning validation testing Transfer drug product analytical methods to QC Perform cleaning validation testing Prepare transfer report Reports Prepare “Data Only” documentation for CMC section.

More Definitions of Master Formula

Master Formula means a set of instructions outlining in detail the materials, equipment, and procedures required to produce a specific quantity of a product;

Master Formula means a document containing details in relation to determination of quantity of raw materials, containers or packaging materials used in the manufacture of each formulation in accordance with the specified manufacturing procedures, including important precautions and recommendations in the manufacturing processes and in-process controls.