Master Formula definition

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.
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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.
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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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Examples of Master Formula in a sentence

  • 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.

  • 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.

  • 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”).

  • 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.

  • 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.

  • Reviewing and, if acceptable, approving all Master Formula Batch Records.

  • 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.

  • 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;
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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.
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Related to Master Formula

  • Payout Formula means as to any Performance Period, the formula or payout matrix established by the Committee pursuant to Section 3.4 in order to determine the Actual Awards (if any) to be paid to Participants. The formula or matrix may differ from Participant to Participant.

  • Infant formula means a food that is intended for con- sumption by infants.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.

  • Formula means the appropriate secondary road fund distribution formula or farm-to-market road fund distribution formula as defined in subrules 102.2(2) and 102.2(3).

  • Rate of Gross Profit means the gross profit earned expressed as a percentage of the turnover during the period between the date of the commencement of the business and the date of the incident.

  • Program Parameter means, in respect of a program, the provincial standards (such as operational, financial or service standards and policies, operating manuals and program eligibility), directives, guidelines and expectations and requirements for that program;

  • Performance Formula means, for a Performance Period, the one or more objective formulae applied against the relevant Performance Goal to determine, with regard to the Performance Compensation Award of a particular Participant, whether all, some portion but less than all, or none of the Performance Compensation Award has been earned for the Performance Period.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Accrual Components As specified in the Preliminary Statement.

  • Net Sales means [***].

  • Investment product means a financial instrument (within the meaning of Article 4(1)(15) of MiFID II) or a structured deposit (within the meaning of Article 4(1)(43) of MiFID II).

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • Multiple tomogram system means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Three-Month Term SOFR Conventions means any determination, decision or election with respect to any technical, administrative or operational matter (including with respect to the manner and timing of the publication of Three-Month Term SOFR, or changes to the definition of “Floating Interest Period”, timing and frequency of determining Three-Month Term SOFR with respect to each Floating Interest Period and making payments of interest, rounding of amounts or tenors, and other administrative matters) that the Company decides may be appropriate to reflect the use of Three-Month Term SOFR as the Benchmark in a manner substantially consistent with market practice (or, if the Company decides that adoption of any portion of such market practice is not administratively feasible or if the Company determines that no market practice for the use of Three-Month Term SOFR exists, in such other manner as the Company determines is reasonably necessary).

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Manufacturing Cost means [***].

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • COGS means the cost of goods sold as determined in accordance with U.S.GAAP;

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Class Coupon Formula The formula specified for each Class of variable rate Notes, as set forth in Appendix I for Original Notes and Appendix II for MAC Notes.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • Corresponding Component As identified in the Preliminary Statement with respect to any Class of Non-Vertically Retained Principal Balance Certificates or Lower-Tier Regular Interest.