GMP Guidelines Sample Clauses

GMP Guidelines. The principles detailed in the US Current Good Manufacturing Practices (21 CFR 210 and 211) that govern the standards of manufacture for active pharmaceutical ingredients, as well as the product Guidance for Industry “Q7A Good Manufacturing Practice, Guidance for Active Pharmaceutical Ingredients”, will govern (i) the standards of manufacture of the PRODUCT, (ii) the product specifications, (iii) any applicable product license, and (iv) the NDA/ANDA application, pharmacopoeia or formulatory requirements.
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GMP Guidelines. 5.3.1 The principles detailed in the US Current Good Manufacturing Practices (21 CFR 200, 211, and 600) and the Rules Governing Medicinal Product in The European Community—Volume IV Good Manufacturing Practice for Medicinal Products Guidelines will cover the standards of manufacture of the PRODUCTS, as well as, the product specifications and any applicable product license or pharmacopoeia or formulatory requirements.
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GMP Guidelines. The premises, equipment and systems used to manufacture and release the Product must be in compliance with all applicable GMP requirements for APIs, including the principles detailed in the US Code of Federal Regulations, Parts 11, 210, 211, and ICH Q7 GMP Guide for APIs, as accepted and implemented by the national and international regulations of the European Community, the United States of America, Japan and the member slates of the PIC scheme.
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GMP Guidelines. Any applicable product license or pharmacopoeia requirements applicable to the Manufacture of Product(s) shall be complied with in addition to cGMP and Specifications.
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GMP Guidelines. 5 5.4 Materials............................................. 5 5.5
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GMP Guidelines. The cGMP guidelines to be applied are the United States cGMPs listed in 21 Code of Federal Regulations (CFR) Parts 11 Electronic Records, 200, 210, and 211 and associated Compliance Guidances.
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GMP Guidelines. 3 5.4 MATERIALS...................................................3 5.5 MASTER PRODUCTION RECORDS...................................4
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GMP Guidelines. Any applicable API license or pharmacopoeia or formulatory requirements applicable to the Manufacture of APIs shall be complied with in addition to cGMP, Q7A, and Specifications.
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Related to GMP Guidelines

  • Guidelines The Office of State Procurement adheres to all guidelines set forth by the State and Federal Government concerning The Americans with Disabilities Act (ADA) as well as all mandated fire codes.

  • Trading Guidelines BNYMCM may, to the extent permitted under the Securities Act and the Exchange Act, purchase and sell Common Stock for its own account while this Agreement is in effect provided that (i) no such purchase or sale shall take place while an Issuance Notice is in effect (except to the extent BNYMCM may engage in sales of Issuance Shares purchased or deemed purchased from the Company as a “riskless principal” or in a similar capacity), (ii) in no circumstances shall BNYMCM have a short position in the Common Stock for its own account and (iii) the Company shall not be deemed to have authorized or consented to any such purchases or sales by BNYMCM. The Company hereby acknowledges and agrees that BNYMCM’s Affiliates may, subject to compliance with Regulation M under the Exchange Act and Section 5 of the Securities Act, if applicable, make markets in the Common Stock or other securities of the Company, in connection with which they may buy and sell, as agent or principal, for long or short account, shares of Common Stock or other securities of the Company, at the same time BNYMCM is acting as agent pursuant to this Agreement.

  • Investment Guidelines In addition to the information to be provided to the Sub-Advisor under Section 2 hereof, the Trust or the Advisor shall supply the Sub-Advisor with such other information as the Sub-Advisor shall reasonably request concerning the Fund’s investment policies, restrictions, limitations, tax position, liquidity requirements and other information useful in managing the Fund’s investments.

  • Collection Guidelines As long as it is the Servicer, CAC will comply in all material respects with the Collection Guidelines or otherwise as required by Applicable Law in regard to each Loan and Contract.

  • Stock Ownership Guidelines Executive will comply with all stock ownership and stock retention guidelines or policies established by the Board and the Committee, as in effect from time to time.

  • Policies and Procedures i) The policies and procedures of the designated employer apply to the employee while working at both sites.

  • Accounting Policies and Procedures Permit any change in the accounting policies and procedures of the Company or any Guarantor, including a change in fiscal year, provided, however, that any policy or procedure required to be changed by the Financial Accounting Standards Board (or other board or committee thereof) in order to comply with Generally Accepted Accounting Principles may be so changed.

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  • Underwriting Guidelines A true and correct copy of the Underwriting Guidelines certified by an officer of the Seller.

  • Compliance Policies and Procedures To assist the Fund in complying with Rule 38a-1 of the 1940 Act, BBH&Co. represents that it has adopted written policies and procedures reasonably designed to prevent violation of the federal securities laws in fulfilling its obligations under the Agreement and that it has in place a compliance program to monitor its compliance with those policies and procedures. BBH&Co will upon request provide the Fund with information about our compliance program as mutually agreed.

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