gmp口诀（GMP formula）.docVIP

gmp口诀（GMP formula） GMP formula: General quality, organization, plant, facilities, equipment, etc. Product identification and verification, documentation production to counterparts Quality assurance, when dedicated, production inspection commissioned clear Recall shipment has provisions, self-examination, self-examination is the core Chapter I General Provisions According to one law and one regulation, the quality management system is established Aims to ensure that four guarantees, honesty and trustworthiness, not self deception The second chapter is quality management Ten basic requirements, the formulation process and proved Process changes are verified, equipped with six items of resources A qualified person, with two allocation of space and plant Three, equipped with equipment and protection, four, with the original, auxiliary and packaging Five, process and operation, six storage and transportation conditions Easy to understand language, written procedures, operator training The whole process of production records should be kept clear of deviations Shipment record batch record for easy access and traceability Shipment risk should be lowered and recall system should be prevented Complaints, defects, reasons for investigation, prevention of recidivism measures The third chapter, organization and personnel Production management personnel, the main responsibilities of six thousand jin Ensure the quality according to the procedures, strict implementation of related operations The production record is handed in and checked, and the plant and equipment are running well Necessary to verify warranty completion, production training is fundamental Common responsibility, ten whole, influence factor all stare at. First, examination and approval procedures, and second supervise the factory sanitation Third the equipment has been confirmed and the fourth process should be verified Fifth, joint training, sixth commissioned approval Seven keep the storage condition, eighth keep