ज्ञान सरिता - Spreading the Fragrance of Knowledge - Pharma Regulatory / GMP Compliance Solution

Good Manufacturing Practices :  Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements. This article contains the list of GMP Guidelines applicable for the Production and Qualit...

What is a Regulatory Agency :  A regulatory agency  ( regulatory body ,  regulator ) or  independent agency  ( independent regulatory agency ) is a  government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity. Functions of Drug Regulatory Agencies :  The Food and Drug Administration and or Agencies are the part of Department of the Health and Human Services of the individual countries. For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health. These agencies are responsible for protecting and promoting public health through the control and supervision of: Food Safety; Tobacco Products; Dietary Supplements; Prescription and over-the-counter pharmaceutical drugs (medicines); Vaccines; Biopharmaceuticals; Blood transfusions, ...