HAND SANITIZER GMP (Good Manufacturing Practice)
Hand Sanitizer manufacturers should comply with GMP regulations. GMP (Good Manufacturing Practice) is a set of regulations covering the manufacturing, processing, packaging facilities and controls for manufacturing enforced by the United States Food and Drug Administration (FDA) to ensure the quality of products such as hand sanitizers. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for intended human use.
The FDA regulates antiseptic hand sanitizer as an over the counter (OTC) monograph drug (TFM Part 333 A) and Hand Sanitizer GMP (Good Manufacturing Practice) is applicable to any facilities engaged in dealing with Hand Sanitizers. Hand Sanitizer manufacturers must comply with all the OTC drug regulations, which includes FDA GMP. These are the Quality Management System practices required in order to conform to the guidelines recommended by the FDA that control the authorization and licensing of the manufacture and sale of hand sanitzers.