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  2. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  3. Control chart - Wikipedia

    en.wikipedia.org/wiki/Control_chart

    Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. (ISO 7870-1) [1] The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line.

  4. Laboratory quality control - Wikipedia

    en.wikipedia.org/wiki/Laboratory_quality_control

    An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.

  5. Certificate of analysis - Wikipedia

    en.wikipedia.org/wiki/Certificate_of_analysis

    By extension, this often means regulations, standards, and/or guidelines are in place to better ensure analyses are approved and reported correctly. For example, regulations, standards, and/or guidelines affect COA use in agriculture, [2] [3] chemical, [4] [5] clinical research, [6] [7] food and beverage, [8] [9] and pharmaceutical [6] [7] [10 ...

  6. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).

  7. Acceptance sampling - Wikipedia

    en.wikipedia.org/wiki/Acceptance_sampling

    In general, acceptance sampling is employed when one or several of the following hold: [2] testing is destructive; the cost of 100% inspection is very high; and; 100% inspection takes too long. A wide variety of acceptance sampling plans is available. For example, multiple sampling plans use more than two samples to reach a conclusion.

  8. Lot quality assurance sampling - Wikipedia

    en.wikipedia.org/wiki/Lot_Quality_Assurance_Sampling

    Lot quality assurance sampling (LQAS) is a random sampling methodology, originally developed in the 1920s [1] as a method of quality control in industrial production. Compared to similar sampling techniques like stratified and cluster sampling , LQAS provides less information but often requires substantially smaller sample sizes.

  9. Preferred Reporting Items for Systematic Reviews and Meta ...

    en.wikipedia.org/wiki/Preferred_reporting_items...

    The PRISMA flow diagram, depicting the flow of information through the different phases of a systematic review. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is an evidence-based minimum set of items aimed at helping scientific authors to report a wide array of systematic reviews and meta-analyses, primarily used to assess the benefits and harms of a health care ...