GMP Manufacturing definition

GMP Manufacturing means all processes and activities typically engaged in by a person or entity in the pharmaceutical or medical device industry for the GMP manufacture of a product or component thereof, including procuring raw materials, manufacturing, quality control and assurance testing, GMP record keeping, packaging and labeling.
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Examples of GMP Manufacturing in a sentence

  • During manufacturing of the GMP Batches, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the GMP Manufacturing Process for the purpose of observing and reporting on the performance of the Services.

  • Figure 1: Setting up GMP Manufacturing Facility Process Flow The manufacturer may submit an application for the Evaluation of Manufacturing Plant Layout (BPFK-503) to the Good Manufacturing Practice Section, Centre of Compliance and Quality Control for evaluation and approval.

  • Chapter 4 TECHNICAL SPECIFICATION GMP Manufacturing of capsule formulation of New Chemical Entity (IND candidate-IIIM 290- Oncology kead) for FIH clinical studies.Selection of CRO for GMP Manufacturing capsule formulation of New Chemical Entity (IND candidate – IIIM-290 – Oncology lead) for FIH clinical studies CSIR-Indian Institute of Integrative Medicine, Jammu Council of Scientific & Industrial ResearchMinistry of Science & Technology Govt.

  • Cell and Gene Therapy GMP Manufacturing in the UK: Capability and Capacity Analysis.

  • On completion of the AIFA authorisation process for other areas of GMP Manufacturing, MolMed will have trebled its production capacity, adding the rooms and areas built in Bresso to those already operating at San Raffaele Hospital.MolMed is a public company listed since March 2008, on the Mercato Telematico Azionario (MTA - screen- based equity market) managed by Borsa Italiana (Ticker Reuters: MLMD.MI).

  • Chapter 4 TECHNICAL SPECIFICATION Selection of CRO for GMP Manufacturing of New Chemical Entity (IND candidate – IIIM-290) and capsule formulation for FIH clinical studiesSelection of CRO for GMP Manufacturing of New Chemical Entity (IND candidate – IIIM-290) and capsule formulation for FIH clinical studies CSIR-Indian Institute of Integrative Medicine, Jammu Council of Scientific & Industrial ResearchMinistry of Science & Technology Govt.

  • Manufacturing Signature – The GMP Manufacturing Groups’ acceptance of the document.

  • To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of COVID Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s).

  • Carry out Safety Event reporting with respect to any incidents in the GMP Manufacturing Plant.

  • The FTE Rate is “fully burdened” and will cover employee salaries, benefits, travel, and such facilities and equipment and other materials and services including ordinary laboratory and Manufacturing consumables (like, for example, growth media, but not larger out-of-pocket expenses that are used in GMP Manufacturing of a Compound, such as chromatography resins) procured from distributors of relevant products as they may use.

Related to GMP Manufacturing

  • 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.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Manufacturing Process means any process for—

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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.

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • 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.

  • 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.

  • 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.

  • API means the American Petroleum Institute.

  • 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:

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

  • 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;

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • 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.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • 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.