GLP Clause Samples

The GLP (Good Laboratory Practice) clause establishes standards and requirements for laboratory work to ensure the quality, integrity, and reliability of data generated during research or testing. It typically applies to studies involving chemicals, pharmaceuticals, or other regulated substances, requiring laboratories to follow specific protocols, maintain accurate records, and implement quality control measures. By mandating adherence to recognized laboratory practices, this clause helps ensure that results are credible and can be trusted by regulatory authorities, thereby reducing the risk of data manipulation or errors.
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GLP. The term “GLP” shall mean the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the successor thereto, or comparable regulatory standards in jurisdictions outside of the United States as they may be updated from time to time, to the extent such standards are not less stringent than United States standards.
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GLP. The term “GLP” shall mean the applicable good laboratory practice as required by the applicable Regulatory Authorities, including under 21 C.F.R. Part 58 and all related FDA rules, regulations, orders, and guidances, and the requirements with respect to good laboratory practices prescribed by the European Community, the OECD (Organization for Economic Cooperation and Development Council) and the ICH Guidelines, or as otherwise required by Applicable Law.
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GLP. The term “GLP” shall mean the then-current standards, practices, and procedures on good laboratory practice: (a) promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58; (b) set forth in the European Community Directive 2004/10/EC relating to the application of good laboratory practice; (c) comparable standards, practices, and procedures promulgated by Applicable Law or any competent Regulatory Authority of the relevant country in the Territory; and (d) all additional Applicable Law or Regulatory Authority standards, practices, and procedures that re-place, amend, modify, supplant, or complement any of the foregoing.
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Related to GLP

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in ▇▇▇▇ rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Good Industry Practice all applicable Standards; and

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.