GMP Requirements definition

GMP Requirements means the guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in the Commission 2003/94/EC as amended and set out in Volume 4 of Eudralex (the rules governing medicinal products in the European Union), and the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide).
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GMP Requirements means current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the manufacture or sale of the Licensed Product pursuant to its regulations, guidelines or otherwise.
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GMP Requirements means the requirements and guidance in relation to GMP set out in the GMP Directive, the GMP Guidelines and the Regulations.
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Examples of GMP Requirements in a sentence

  • Abbott will maintain a quality system to ensure that the Products are manufactured in accordance with: (a) applicable Quality Systems and GMP Requirements; and (b) all pertinent rules and regulations of the FDA, as the same may be amended from time to time.

  • Products manufactured by Abbott for NeoGenomics under this Agreement shall be manufactured and tested by Abbott in accordance with the Specifications, Quality System and GMP Requirements, and all applicable national, state and local laws, regulations and guidelines.

  • Abbott shall manufacture the Products in accordance with: (a) the Specifications; (b) applicable Quality Systems and GMP Requirements; and (c) all pertinent rules and regulations of the FDA, as the same may be amended from time to time.

  • Items that are registered with the NMPB must strictly comply with of their approved status (manufacturing site, API source, manufacturing process, specifications, packaging material), WHO or SRA Good Manufacturing Process (GMP) Requirements (as the case may be) and requirements relating to quality, safety and efficacy of the relevant supplier product.

  • All Licensed Product supplied by NOVARTIS to ENDO hereunder shall, at the time it is delivered to the carrier by NOVARTIS at the NOVARTIS Warehouse (as defined in Section 5.5(b) below), (a) comply with the Specifications, (b) be consistent, as applicable, with the Licensed Product NDA, and (c) have been manufactured in a facility and in a manner compliant with GMP Requirements and all applicable Laws.

  • ABI shall manufacture the Product in accordance with all applicable laws and regulations, including, without limitation, the Quality Systems and GMP Requirements.

  • Rahman.After reviewing the existing product registration requirements (regarding GMP), the Drug Control Authority (DCA) has agreed to impose GMP Requirements for the registration of pharmaceutical products from overseas.

  • The Parties shall exchange information concerning their Mandatory GMP Requirements and GMP Compliance Programs, including any new technical guidance or inspection procedure.

  • Supplier shall be responsible for Manufacturing the Product in compliance with Applicable Law, c GMP Requirements and the standards of any other applicable governmental or regulatory authority.

  • Directive 01/2012: Good Manufacturing Practice (GMP) Requirements for the Registration of Pharmaceutical Products from OverseasA directive under Regulation 29 of the Control of Drugs and Cosmetics Regulations 1984 (Revised 2006) has been issued by the Senior Director of Pharmaceutical Services, Dato’ Eisah A.


More Definitions of GMP Requirements

GMP Requirements means the current good manufacturing practice provisions set forth in the (a) FDCA, relevant regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Parts 11, 210, 211, 600 and 610), guidance documents issued by the FDA, and all successor regulations and guidance, and (b) European Commission Directive 2003/94/EEC of 08 October 2003 and any guidance adopted pursuant to that Directive, including the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, and any successor legislation and guidance.
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GMP Requirements means the GMP requirements referred to in section 12E of the 1993 Act by reference to this Scheme.».
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GMP Requirements means good manufacturing practices for medicinal products for human use as applicable in the UK (currently EU GMP Directive 2003/94/EC and as and set out in Volume 4 of Eudralex (the rules governing medicinal products in the European Union), and the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide).
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GMP Requirements. The guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in the Commission 2003/94/EC, or as replaced by Directive 2017/1572 and/or Regulation 2017/1569 as appropriate and set out in Volume 4 of Eudralex (the rules governing medicinal products in the European Union), and the MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide)
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GMP Requirements has the meaning set forth in sec. 3.18.1
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Related to GMP Requirements

  • OHS Requirements means all Laws applicable to the Supply and related to occupational health or safety, and all of the City Policies that relate to occupational health or safety, and includes without limitation the WCA;

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

  • Minimum Requirements means the minimum requirements for available commercial structures. The minimum requirements may be found at this link: https://portlandgeneral.com/energy- choices/renewable-power/green-future-impact The minimum requirements may be updated from time to time to reflect PGE’s criteria from its latest Commission accepted renewable request for proposals.

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Service Requirements means the specification that the Flexibility Services must be capable of meeting, as defined in Schedule 1;

  • Requirements means and include schedules, details, description, statement of technical data, performance characteristics, standards (Indian as well as International) as applicable and specified in the Contract.

  • Listing Requirements means the Main Market Listing Requirements of Bursa Securities.

  • Design requirements means the written description of the infrastructure facility to be procured pursuant to this article, including:

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Privacy Requirements means all applicable Privacy Laws and all of the Company’s and the Company Subsidiaries’ policies, notices, and contractual obligations relating to the Processing of Personal Information.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • Reporting Requirements As defined in Section 11.15.

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Minimum Balance Requirements The minimum balance to open the account is $5.00. If the balance falls below $5 at any time, the account may be closed. See Balance Computation Method above. Fees and Charges; Other Requirements: See our Schedule of Fees at xxxxxxx.xxx/xxxx. Dividends: See Disclosures Concerning Dividends above. Current rates are disclosed on the Credit Union’s website.

  • Maintenance Requirements shall have the meaning set forth in Clause 14.2;

  • Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements, guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.

  • Relevant Requirements means all applicable Law relating to bribery, corruption and fraud, including the Bribery Act 2010 and any guidance issued by the Secretary of State for Justice pursuant to section 9 of the Bribery Act 2010;

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;

  • End Client Requirements means the specific requirements of the End Client, as notified to the Supplier in writing;

  • Risk Retention Requirements means the credit risk retention requirements of Section 15G of the Exchange Act (15 U.S.C. §78o-11), as added by Section 941 of the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act.

  • Regulatory Requirement means any law, regulation or court order, or any rule, direction, guideline, code, notice or restriction (whether or not having the force of law) issued by any regulatory authority, governmental agency (including tax authority), clearing or settlement bank or exchange, or industry or self-regulatory body, whether in or outside Hong Kong, to which HKICL, we or any other Participant or the respective affiliates or group companies, or you are subject or are expected to comply with from time to time.

  • Security Requirements means the requirements regarding the security of Personal Data, as set out in the Data Protection Laws (including, in particular, the seventh data protection principle of the DPA and/ or the measures set out in Article 32(1) of the GDPR (taking due account of the matters described in Article 32(2) of the GDPR)) as applicable;

  • Performance Requirements The ordering entity reserves the right to inspect and verify that all deliveries are in accordance with specifications, both at the point of delivery and at the point of use. For orders that specify an “authorized party” to receive and inspect deliveries and/or installations, acceptance and inspection procedures must be performed by the” authorized party” to be considered and accepted by the ordering entity. Products inspected at the time of use are subject to refusal and return requirements for issues of quality such as defects in manufacturing and/or workmanship. Products will not be considered accepted by the ordering entity until the installation is complete for the applicable products.

  • Mandatory City Requirements means those City laws set forth in the San Francisco Municipal Code, including the duly authorized rules, regulations, and guidelines implementing such laws that impose specific duties and obligations upon Contractor.