3. Pharmaceutical Industry - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory
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    Pharmaceutical Manufacturing Processes

    The Pharmaceutical industry is one of the important wing of health care sector throughout the world. Pharmaceutical processing is the systematic way of manufacturing pharmaceutical drugs. Pharmaceutical industry is dependent upon the research based work of drugs, diseases and disorders. Generally, the molecular biologists, medical chemists and pharmacists handled the pharmaceutical manufacturing.

    In Pharmaceutical processes of drug manufacturing includes blending, compression, filtration, heating, encapsulation, shearing, tableting, granulation, coating, tablet pressing, filling are the key steps of manufacturing the pharmaceutical drugs. Critical Process Parameter (CPP) is the standard level for manufacturing pharmaceutical drugs and have the direct impact on the Critical Quality Attribute (CQA) of drugs. In India, CPP covers the FDA (Food and Drug Administration) for maintaining the drug regulation framework. Besides, GMP (Good Manufacturing Standards) also applied on the manufacturing of the pharmaceutical drugs.

    EFRAC is NABL accredited research and analysis centre with 11 Regulatory Accreditations and 3 International Recognitions and has been offering World-Class Analytical Facility for the drug testing. EFRAC is known for Quickest Turn Around Time (TAT) in the industry for providing pharmaceutical drug testing. EFRAC’s facilities include different branches of research and analysis like drugs and pharmaceutical services.

    Critical Process Parameters (CPP)

    • Dissolved oxygen
    • Dissolved Carbon Dioxide
    • Exhaust O2 and Co2-off gas
    • Nutrients and Metabolites
    • Temperature control
    • Chemical and Physical pressure
    • Oxidation Reduction Potential
    • pH

    Instruments

    • GC-MS/HS • GC-MS/P&T • Ion-Chromatography • TOC Analyser • ICP-MS

    Methods

    • FDA lab manuals
    • IS
    • Indian Pharmacopeia