Validation for Moxifloxacin Tablet
Keywords:
Quality Assurance, Validation, Good Manufacturing Practices & FDA.Abstract
Quality Assurance includes management of the quality of raw materials, assemblies, products and component,
management, production, validation and inspection processes. Validation is action of providing in accordance with
principle of GMP, that any procedure, process, equipment, materials activity or system actual leads to expected
results". At various stages in a validation/qualification exercise there is need for protocols, documentation,
procedure, equipment, specifications and acceptance criteria for test results. The FDA has the authority and
responsibility to inspect and evaluate process validation performed by manufactures. The cGMP for validated
formulations (drugs) manufacturing required that drug product be produced with a high degree of assurance meeting
all the attributes they are intended to process of meeting all the attributes they are intended to process. All the
physical parameters of all three batches were found well within the acceptable limits.
