Terms & Definitions • 345 quality control (QC) Sponsored by
Activities undertaken within the quality management system to verify that operational activities and derived data have been verified. Quality control (QC) is essential in the pharmaceutical industry to
ensure that drug products are safe and produced as labeled. QC is achieved through analytical means using a pre-existing or specially developed method that specifies the exact materials and standards against which samples should be measured. All drug products, whether generic or a new molecular entity, depends on this process. Method development is a major component of QC and can begin at
nearly any stage in drug discovery, from target identification and validation through to preclinical development, clinical development, manufacturing, and control of the final product. To ensure drug candidates move swiftly through the development process, contract research organizations and pharmaceutical companies often standardize and reduce the number of methods in use by ensuring their suitability for research as well as manufacturing. However, new methods are often necessary, especially if new raw materials are introduced to the drug as it progresses to clinical trial or is scaled for manufacturing. Like their counterparts in other industries, quality control chemists
often find themselves under distinct deadline pressure or control backlogs and must quickly but precisely process samples to keep the production pipeline moving. QC scientists must also stay up-to-date with regulatory guidelines that are subject to frequent change even in between full updates from pharmacopeia organizations. Merck collaborates, assists, and partners with QC scientists to provide
workflow solutions and scientifically informed choices at every stage of the QC process. We provide not only pharmacopeia-accredited products but also the assurance and support to effectively develop methods and stay apprised of industry changes. We actively facilitate lab-to-lab cross-validation through reliable data, more predictive workflows, and access to experts who understand increased regulatory demands. Our extensive experience in the industry and collaboration with an in-house pharma operation of our own put us in a position to uniquely understand our QC customers, make relevant assessments of their challenges, and allow them to feel better about QC. We offer solutions for method development scientists that have a positive effect overall on pharma labs and organizations.
future science group
www.future-science.com
S83
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136
