The International Conference on Harmonization (ICH GUIDELINES) of Technical Requirement for Registration of Pharmaceuticals for Human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to…
Total Quality Management (TQM) refers to management methods used to enhance quality, based on the participation of all members & aiming all long term success through customer’s satisfaction & benefits…
Good Laboratory Practice is defined in the OECD Principles as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are…
VALIDATION: The validation of a test method is the process by which the relevance and reliability of the method are assessed for a particular purpose. CALIBRATION: Calibration is the activity…
Statistical quality control must be regarded as a package of gear which can also additionally have an impact on selections to the features of specification, manufacturing or inspection. CHARACTERISTICS OF…
Quality Variation: When the first-rate of any drug is given via way of means of industry, then it’s far accountable for any variant from the standard. Quality Variation might also…