cGMP Activities definition

cGMP Activities means activities directly related to ensuring compliance with current Good Manufacturing Practice (cGMP) requirements contained in the Federal Food, Drug, and Cosmetic Act and applicable regulations (collectively “cGMP Requirements”), to submitting cGMP-related reports and information to the FDA, and/or responding to FDA inspectional observations or other correspondence, including correspondence regarding cGMP Requirements.
Sample 1

Examples of cGMP Activities in a sentence

  • In the event that, after the Effective Date, GSK purchases or establishes a new business unit or location related to or engaged in any of the Covered Functions or in cGMP Activities, GSK shall notify OIG no later than five days after the date that the purchase or establishment of the new business unit or location is publicly disclosed by GSK.

  • The GMS Compliance Officer shall be responsible for overseeing the development and implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this Appendix relating to cGMP Activities, with applicable Federal health care program requirements and applicable FDA requirements.

  • Persons providing the training shall be knowledgeable about the subject area, including about FDA requirements relating to cGMP Activities.

  • GSK represents that it provides training on a regular basis concerning a variety of topics directly related to cGMP Activities.

  • The Board shall be responsible for the oversight of matters related to compliance with cGMP Activities, applicable Federal health care program requirements, applicable FDA requirements, and the obligations of this Appendix.

Related to cGMP Activities

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • Project Activities means the activities to be undertaken or Works to be delivered or Property to be contributed or provided by you, your approved Sub-Grantees or your approved sub- contractors as summarised in the Particulars and more particularly described in the Agreed Proposal for which Xxxxx is payable under this Agreement;

  • Economic activities shall in principle include activities of an industrial, commercial and professional character and activities of craftsmen;

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • licensed activities means things authorised to be done by the licence

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.

  • Activities has the meaning specified in Section 7.02(b).

  • Power production activities means any business operation that involves a project commissioned by the government of Iran whose purpose is to facilitate power generation and delivery, including, but not limited to, establishing power-generating plants or hydroelectric dams, selling or installing components for the project, providing service contracts related to the installation or maintenance of the project, as well as facilitating such activities, including by providing supplies or services in support of such activities.

  • High Risk Activities means uses such as the operation of nuclear facilities, air traffic control, or life support systems, where the use or failure of the Services could lead to death, personal injury, or environmental damage.

  • Motorsport Activities means any motorsport activities or Recreational Services which are permitted or approved which Motorsport Australia regulates or administers or otherwise are under the responsibility / control of Motorsport Australia;

  • Interscholastic Activities means athletic or non-athletic/academic activities where students compete on a school vs. school basis.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Permitted Activities The primary activities of the trust created pursuant to this Agreement which shall be:

  • Covered Activities means those land uses and conservation and other activities described in Chapter 2.3 of the HCP/NCCP to be carried out by the Conservancy or its agents that may result in Authorized Take of Covered Species during the term of the HCP/NCCP, and that are otherwise lawful.

  • Commercial Activities means activities conducted on a commercial basis.

  • Intrascholastic Activities means athletic or non-athletic/academic activities where students compete with students from within the same school.

  • Motor Sport Activities means any motor sport activities or Recreational Services which are permitted or approved which CAMS regulates or administers by CAMS or otherwise under the responsibility / control of CAMS;

  • Restricted Activities means and includes the following:

  • Commercial cannabis activity means the production, cultivation,

  • Competing Activities means the same or similar services as Xxxxxx Xxx Ltd is providing to the Restaurant under this Agreement or other activities having a similar purpose.

  • Development Work means the work of development to be performed on or with respect to the Land (including, without limitation, the installation of utilities, roads and all related on-site and off-site improvements) in connection with the development of the Land for the subsequent construction thereon of Homes, all of which work and construction shall be completed by or on behalf of the Borrower in accordance with the Plans and Specifications, but shall not include the Construction Improvements.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Funded Activities means the activities set out in Annex 2 of these Conditions; Funding Period means the period for which the Grant is awarded starting on the Commencement Date and ending on [INSERT PROJECT END DATE]; General Data Protection Regulations and GDPR means (Regulation (EU) 2016/679); Grant means the sum or sums the Authority will pay to the Grant Recipient in accordance with paragraph 4 of these Conditions and subject to the provisions set out at paragraph 26.

  • Service activities means activities in connection with the provision of personal, continuing services to shareholder accounts in the Shares; provided, however, that if the National Association of Securities Dealers, Inc. (“NASD”) adopts a definition of “service fee” for purposes of Section 2830(b)(9) of the NASD Conduct Rules or any successor provision that differs from the definition of “service activities” hereunder, or if the NASD adopts a related interpretive position intended to define the same concept, the definition of “service activities” in this paragraph shall be automatically amended, without further action of the parties, to conform to the then effective NASD definition. Overhead and other expenses related to “distribution activities” or “service activities,” including telephone and other communications expenses, may be included in the information regarding amounts expended for these activities.

  • Business Activities shall be deemed to include any activities which are included in the Company's Business now or during the effective period of this Agreement.

  • Construction Activities means the disturbance of soils associated with clearing, grading, excavation activities or other construction-related activities.