cGMP Rules definition

cGMP Rules means the quality systems and current good manufacturing practices set forth in 21 C.F.R. (Parts 210 and 211 and Parts 600 and 610 (as applicable)), and applicable FDA rules and regulations, promulgated thereunder.

Related to cGMP Rules

  • PPB Rules means the rules of the Procurement Policy Board as set forth in Title 9 of the Rules of the City of New York (“RCNY”), § 1-01 et seq.

  • FCA Rules means the Rules included within the FCA Handbook issued by the FCA.

  • M&A Rules means the Provisions on Merging and Acquiring Domestic Enterprises by Foreign Investors, which was promulgated by six Governmental Agencies, namely, the Ministry of Commerce, the State-owned Assets Supervision and Administration Commission, the State Administration for Taxation, the State Administration for Industry and Commerce, the China Securities Regulatory Commission (the “CSRC”), and the State Administration of Foreign Exchange, on August 8, 2006 and became effective on September 8, 2006, as amended by the Ministry of Commerce on June 22, 2009.

  • HIPAA Rules means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.

  • DOE Rules means DOE’s energy conservation regulations found in Title 10, Parts 429, 430, and 431 of the Code of Federal Regulations.

  • Applicable Laws/ Rules means the laws/ Rules of Islamic Republic of Pakistan/Punjab, as they may be issued and enforced from time to time.

  • PRA Rules means the Rules included within the PRA handbook issued by the PRA.

  • ISO-NE Rules means all rules and procedures adopted by NEPOOL, ISO-NE, or the RTO, and governing wholesale power markets and transmission in New England, as such rules may be amended from time to time, including but not limited to, the ISO-NE Tariff, the ISO-NE Operating Procedures (as defined in the ISO-NE Tariff), the ISO-NE Planning Procedures (as defined in the ISO-NE Tariff), the Transmission Operating Agreement (as defined in the ISO-NE Tariff), the ISO-NE Participants Agreement, the manuals, procedures and business process documents published by ISO-NE via its web site and/or by its e-mail distribution to appropriate NEPOOL participants and/or NEPOOL committees, as amended, superseded or restated from time to time.

  • SIFT Rules means the provisions of the Tax Act, including those contained in sections 104, 122 and 122.1 of the Tax Act, which apply to the taxation of a “specified investment flow through trust” and its unitholders.

  • Site Rules means all rules, regulations, directives and policies notified by the Company from time to time which are intended to be of general application to persons at a Site controlled or managed by the Company.

  • FSA Rules meanss the rules, guidance, principles and codes comprised in the Handbook of Rules and Guidance issued by the FSA. The parties understand and agree that such categorisation is not intended to, and does not, affect the relationship between and among the parties under the 1940 Act or the Advisers Act.

  • AIM Rules means the rules published by the London Stock Exchange governing admission to AIM and the regulation of AIM companies as amended or re-issued from time to time;

  • NYSRC Reliability Rules means the rules applicable to the operation of the New York Transmission System. These rules are based on Reliability Standards adopted by NERC and NPCC, but also include more specific and more stringent rules to reflect the particular requirements of the New York Transmission System.

  • Regulatory Rules means all corporate and securities laws, regulations, rules, policies, notices, instruments and other orders of any kind whatsoever which may, from time to time, apply to the implementation, operation or amendment of this Plan or the Options granted from time to time hereunder including, without limitation, those of the applicable Regulatory Authorities.

  • ACH Rules means the NACHA Operating Rules and NACHA Operating Guidelines, as in effect from time to time.

  • House Rules means written and posted rules governing house activities in the AFH-DD. These rules may not conflict with the AFH Bill of Rights.

  • Relevant Rules means, at any time, the laws, regulations, requirements, guidelines and policies relating to capital adequacy (including, without limitation, as to leverage) then in effect in the United Kingdom including, without limitation to the generality of the foregoing, as may be required by CRD IV or BRRD or any applicable successor legislation or any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and applicable to the Issuer from time to time and any regulations, requirements, guidelines and policies relating to capital adequacy adopted by the Relevant Regulator from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer or to the Issuer and any of its holding or subsidiary companies or any subsidiary of any such holding company).

  • JAMS Rules has the meaning assigned thereto in Section 13 hereof.

  • CCASS Rules means the General Rules of CCASS and the CCASS Operational Procedures in effect from time to time;

  • Market Rules means the rules made under section 32 of the Electricity Act;

  • SAFE Rules and Regulations means collectively, the Circular 37 and any other applicable SAFE rules and regulations, as amended.

  • 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.

  • the Rules means the Insolvency Rules 1986 (as amended);

  • HKIAC Rules shall have the meaning ascribed to it in Section 10.13(a).

  • Hague Rules means the International Convention for the Unification of certain Rules of Law relating to Bills of Lading signed at Brussels on 25 August 1924.

  • Model Rules means the State of Oregon’s Attorney General’s model rules of procedure for Public Contracting, which are set forth in OAR Chapter 137, divisions 46, 47, 48, and 49, and required under ORS 279A.065.