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  • SCHEDULE M - ipapharma. org
    [SCHEDULE M] [See Rules 71, 74, 76 and 78] GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS Note: - To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for
  • Update on Drugs Cosmetics Act and Revised Schedule M: 28 June 2024.
    dated 05 10 2018regarding amendment in Schedule M of Drugs and Cosmetics Rules, 1945 Objections suggestions were received from stakeholders on the draft notification G S R 999 (E) dated 05 10 2018 was deliberated and considered accordingly The central Government has finalized the draft notification vide G S R 922(E) dated 28 12 2023 after consultation with Drugs Technical Advisory Board
  • Govt notifies revised schedule M guidelines for pharma manufacturing . . .
    The Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production Till now there was no provision for informing the licensing authority about drug recall Schedule M part of Drugs and Cosmetics Act 1940 deals with 'Good Manufacturing Practices' to be followed by pharmaceutical manufacturing units in the country
  • Revised Schedule M- GMP (using Infographics) - Pharmaguddu
    Schedule M for GMP covers all aspects of pharmaceutical manufacturing, including facilities, equipment, personnel, documentation, and quality control Objectives of Schedule M The objective of Schedule M for GMP is to ensure that pharmaceutical manufactured products are safe, effective, and of high quality It achieves this objective by setting minimum standards for GMP and requiring pharmaceutical manufacturers to comply with these standards
  • Revised Schedule M Deadline Extension: Latest Notification Draft G. S. R . . .
    However, the revised schedule M has various specifications and requirements Extensive knowledge of the guidelines will be required to properly implement the guidelines Thus, taking the help of a consultant for revised schedule M implementation, will be beneficial G S R 10 (E) draft notification: Revised schedule M deadline extension
  • Revised GMP Guidelines and requirements under Schedule M - PMDA
    •GMP and the Requirements under Schedule M have been revised vide G S R 922(E) dated 28 12 2023 to make it harmonized with WHO Guidelines •Manufacturing premises should be exclusively used for production of drugs •It will come into force for implementation as under:— Category of manufacturers Time line for implementation Large
  • Revised Schedule M under Drugs Rules, 1945 notified
    New Delhi, 6 Jan 2024: The Union Health Ministry has notified the Revised Schedule M guidelines under which pharmaceutical companies will have to intimate the licensing authority about recalling a drug and also report product defects, deterioration or faulty production
  • Press Release:Press Information Bureau
    Central Government has amended the Drugs Rules 1945 vide G S R 922 (E) dated 28 12 2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products In order to ensure the quality of drugs and to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers (SDCs) have conducted risk-based inspections of 275 premises
  • New Schedule M - sidvim
    Indian Regulatory Authority CDSCO has published a draft version of revised “Schedule M” The objective behind the revision of Schedule M is the harmonisation of quality standards with current global regulatory requirements The harmonisation is similar to the requirements of PIC s standards This will help many small and medium companies to compete in export markets, regulated markets
  • Revised Schedule M: A Game Changer for Pharmaceutical Marketing
    Key changes in the Revised Schedule M Schedule M, incorporated as a part of the Drugs and Cosmetics Act in 1988, helped to set foundational standards for the manufacturing quality of pharmaceutical products The revised Schedule M includes five more categories to ensure compliance with global standards, as follows: Pharmaceutical quality





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