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  • Validation of Cleaning Processes (7 93) | FDA - U. S. Food and Drug . . .
    These Agency documents clearly establish the expectation that cleaning procedures (processes) be validated This guide is designed to establish inspection consistency and uniformity by
  • Scientific justification for monitoring indirect product contact surfaces
    The survey aimed to understand how indirect product contact surfaces are monitored: 35 European companies were canvassed; 57% of them non-sterile; 23% sterile; 11% vaccine; 3% medical device; and 6% hospital
  • Benchmark of Industry Practices: Surface Cleanliness Monitoring - GMP . . .
    For nonproduct contact surfaces, the regulatory requirements and guidance are typically geared towards preventing contamination of the clean rooms environment 10-14 For indirect product contact surfaces, however, the requirements regarding cleaning validation monitoring are not well developed 5
  • Challenges in Sterilizing Indirect Product-Contact Surfaces
    Practice of first cleaning nonproduct-contact areas or low-risk areas, followed by high-risk areas like the stopper bowl in the cleaning procedure As a critical indirect-surface area, the cleaning of the stopper bowl needs to be validated using visual inspection and both analytical and sampling methods
  • CLEANING VALIDATION WITH RISK ASSESSMENT - usp-pqm. org
    Defined Cleaning Validation (CV) for APIs as “The Process of Providing Documented Evidence That the Cleaning Methods Employed Within a Facility Consistently Controls Potential Carryover of Product (Including Intermediates and Impurities), Cleaning Agents and Extraneous Material Into Subsequent Product To a Level Which is
  • Current Trends in Environmental Monitoring: Impact of Recent FDA and . . .
    Effective contamination control in multi-use facilities relies on comprehensive cleaning validation across direct and non-product contact surfaces The FDA and EMA require that these surfaces be cleaned and monitored according to stringent Good Manufacturing Practices (GMP) to ensure no cross-contamination between product batches
  • Pharmaceutical Cleaning Validation Guidance: A Global Regulatory . . .
    By summarizing the specific requirements of each authority and presenting a comparative analysis, this report aims to provide regulatory affairs professionals with a clear understanding of the current global landscape of cleaning validation regulations, thereby facilitating compliance and ensuring the prevention of cross-contamination in pharmac
  • Current FDA Requirements for Cleaning Validation
    In a current Warning Letter, the FDA specifies their requirements for cleaning validation What does the FDA require? In the Warning Letter, the medicinal product manufacturer is criticized for not having written instructions for cleaning and for not having carried out a cleaning validation
  • Sanitary Design and Construction of Food Equipment - Regulations. gov
    2 non-product contact surfaces A food product contact surface is defined as a surface in "direct contact with food residue, or where food residue can drip, drain, diffuse, or be drawn" (FDA, 2004b) Because these surfaces, if contaminated, can directly result in food product contamination, rigid sanitary design criteria must be met Non
  • Cleaning Validation for Biopharmaceutical Manufacturing at Genentech . . .
    Indirect-product-contact surfaces (such as buffer tanks), where there is a significant risk of residues on surfaces contaminating a subsequently manufactured product, also undergo cleaning validation To demonstrate the effectiveness of a cleaning process, the process is challenged





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