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cdsco.gov.in and www.cdscoonline.gov.in The Central Drugs Standard Control Organisation ( CDSCO ) is India 's national regulatory body for cosmetics , pharmaceuticals and medical devices . It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union .
Risk-based inspection (RBI) is an optimal maintenance business process used to examine equipment such as pressure vessels, quick-opening closure - doors, heat exchangers, and piping in industrial plants. RBI is a decision-making methodology for optimizing inspection plans.
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s. [2] India set up its program in the 1980s. [2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010. [2]
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Corrosion loop(s) are systematized analysis "loops" used during Risk-based inspection analysis. Both terms “RBI Corrosion loops” or “RBI corrosion circuits” are generic terms used to indicate the systematization of piping systems into usable and understandable parts associated with corrosion.
Impact of ICFR risk on timing, nature and extent of testing. Extent (sample size): The sample size increases proportionally to ICFR risk. Nature of evidence: Inquiry, observation, inspection and re-performance are the four evidence types, listed in order of sufficiency.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
The central government have established 6 zonal offices of CDSCO (Central Drugs Standard Control Organisation) at Mumbai, Kolkata, Chennai, and Ghaziabad, Hyderabad, Ahmedabad, [5] various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniform enforcement ...
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