Manufacturing Procedure definition

Manufacturing Procedure means the agreed upon manufacturing process as detailed in mutually approved batch production records and Batch Documentation including the testing plan, used by BioVectra to manufacture the Product.
Sample 1
Manufacturing Procedure means the process by which the Starting Materials and any intermediate compounds are used to create the Product as communicated by Keryx to BioVectra from time to time, as detailed in the Quality Agreement, and as memorialized in Batch Documentation, including the testing plan.
Sample 1
Manufacturing Procedure means Celgene's description of the synthesis of Material as provided by Celgene to JMI, attached hereto and incorporated herein as Exhibit A.
Sample 1

Examples of Manufacturing Procedure in a sentence

  • B.3 CHARACTERISTICS OF THE MANUFACTURING PROCEDURE SPECIFICATIONBefore pipe production commences, Manufacturing Procedure Specification (MPS) for manufacturing of pipes and Statistical process control charts shall be prepared by pipe manufacturer (including all information as per clause B.3a), b) and e) of API Spec 5L) and submitted for approval of the Purchaser.

  • Annex B Manufacturing Procedure Qualification for PSL 2 PipeB.1 INTRODUCTION B.l.l This annex specifies additional provisions that apply for the PSL 2 pipes ordered as per this specification.

  • A Manufacturing Procedure outlines an individual, specific process contained within a workstation and designates specific tools and instructions necessary to accomplish a particular process.

  • Confidential Information of Keryx includes (i) the Manufacturing Procedure, Keryx Supplied Materials, Keryx Technology, the Manufacturing Requirements, and Improvements; (ii) development and marketing plans, regulatory and business strategies, financial information, and Forecasts of Keryx; (iii) information regarding the Facility design and construction; and (iv) all information of third parties that Keryx has an obligation to keep confidential.

  • Note: When DOD-STD-100 is referenced on the drawing, PIB7005 may be used for additional clarification.Rocky Mount Suppliers shall refer to the supplier configuration report on the Portal (Supplier Reports) for drawing / specification revisions, Configuration Control Requirements (CCR), Manufacturing Procedure Instruction (MPI), and Preservation and Packaging Specifications (PPS).

  • In addition, the Manufacturing Procedure, see 1-1-A2/5.3.1(a), as implemented by the manufacturer is to be acceptable to ABS.

  • BioVectra will manufacture Product according to GMPs, Manufacturing Procedure, Specifications and quality requirements set forth in the Quality Agreement as well as in accordance with all Applicable Law (collectively, all the forgoing the “Manufacturing Requirements”).

  • Such localized areas must meet a minimum tolerance equal to 95% of specified wall thickness.2) Manufacturing Procedure Qualification Test (MPQT)The pipe manufacturer must produce a minimum of two heats to demonstrate compliance with the specification.

  • Any changes to the Manufacturing Procedure, Manufacturing schedule, the Keryx Release requirements or quality requirements and associated impact(s), including impacts to costs, will be reviewed and assessed prior to implementation, and in all cases subject to the prior mutual agreement of both Parties.

  • Employees with questions regarding interpretation of the policy may discuss them with Human Resources or their Director and/or refer to CSI Pacific Standard Operating Procedures and Guidelines.

Related to Manufacturing Procedure

  • Manufacturing Process means any process for—

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • SOPs has the meaning set forth in Section 5.7(b).

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices (cGMP) and all applicable governmental rules and regulations as applied at the site(s) of manufacture and control, as amended from time to time and in effect during the term of this License Agreement.

  • Ordering Procedures means the ordering and award procedures specified in Clause 6 (Ordering Procedures) and Framework Schedule 5 (Ordering Procedure);

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.