Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOQuality controlQuality Control is one or more organisational unit(s) with defined responsibilities forcontrolling, through checking or testing, that specifications are met.Quality criticalA material (e.g. raw material, packaging material, process aid, intermediate), process step orprocess condition, test requirement or any other relevant parameter is considered to be criticalwhen non-compliance with predetermined criteria directly influences the quality attributes ofthe API in a detrimental manner.Quality functionSum total of activities from Quality Assurance and Quality Control.Quality manualKey document stating the quality policy and briefly describing the quality system of anorganisation.Quality planDocument setting out the specific quality practices, resources, responsibilities and sequence ofactivities relevant to a particular product, project or contract.Quality systemOrganisational structure, procedures, processes and resources needed to implement qualitymanagement.QuarantineThe status of materials isolated physically or by other effective means while awaiting a decisionon their subsequent use.Raw materialAny ingredient intended for use in the production of API.10