Discuss About GMP, Validation, Regulatory, Quality and Compliance GXP4
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Rules of rounding numbers nearest to 10,100,1000etc Rule1:Numbers greater than the half way numbers are rounded to higher 10,100,1000etc Rule2:Numbers...
Motion:The change in position of an object is called motion. There are three laws of motion.
Numbers:All counting elements are called numbers. There are different types of numbers: Natural number Whole number Rational number Irrational number...
Key element of 21 CFR • Validation • Security • Audit trails • Check authority, location and operational • Assigning • Linking/binding of record • Security...
Closed systems are environment where the system access is controlled by the persons who are responsible for the controls of electronic records that are...
An electronic signature based upon cryptographic method or originator authentication, computed by using a set of rules and a set of parameter such that...
The selection of the components from the component list of the 41 products represented by the stimulated product for the purpose of the validation study...
Scope of the Audit: - To prepare an audit checklist for the Design and layout of a production area. To avoid the risk of errors, cross contamination,...
Substandard drugs are genuine products that do not conform to the pharmacopeias standards set for them. Substandard products are often made without complying...
Supply chain risk management is the systematic identification assessment and mitigation of potential disruption in supply chain network with the objective...
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