【正文】 n could accurate operate according to operate rules after training。IX. Establish pharmaceutical goods’ recall system, and ensure any batch delivered and sold products could be recalled。IV. Inspect methods shall be confirmed and validated。 except the finished product with too large package container, the reserved samples’ package shall be the same with the final package of the finished product.Section 4 Quality Risk ManagementArticle 13 Quality risk management is evaluate, control, municate, audit system process to quality risk during the whole product life period, via the manner of foresee or review.Article 14 Quality risk shall evaluate according to science knowledge and experience in order to ensure products’ quality.Article 15 The method, measure, form take during the quality risk management process and the documents formed in the said process shall acmodate to the level of the existent risk. Chapter 3 Organization and Personnel　　　　　　　　　　　　　　　　　　　 Section 1 PrincipleArticle 16 An enterprise shall establish management organization which acmodate to the pharmaceutical goods’ product and have its organization framework chart.The enterprise shall set up independent quality management department, which carries out the responsibilities of quality guarantee and quality control. The quality management department could set up quality guarantee department and quality control department respectively.Article 17 Quality management department shall take part in all activities relating to quality, and take responsibility to audit all documents relating to this Regulation. The personnel in quality management department shall not relegate his responsibility to the personnel in other department.Article 18 The enterprise shall be staffed by an appropriate number of management and technical personnel with appropriate qualification (including education background, training and practice experience), and the responsibilities of each department and each station shall be clarified. Station’s responsibility shall not be missed and cross responsibility shall be prescribed specifically. Responsibility taken by each person shall not be overfull.Every person shall clear and understand his own responsibilities, be familiar with the requirements related to his responsibilities, and accept necessary training, including prejob training and onjob training.Article 19 Generally, one shall not relegate his responsibility to other person. If the responsibilities do need to be relegated, the one should relegate his responsibility to the designated person who has equivalent qualification. Section 2 Important PersonArticle 20 The important person shall be the fulltime person of the enterprise, at least including the director of the enterprise, director of manufacturing management, director of quality management and authorized person of quality.Director of quality management and director of manufacturing management shall be independent of each other. Director of quality management and authorized person of quality shall not be independent of each other. Operation proceduress shall be established so that authorized person of quality could take his responsibility independently, with no interference from director of enterprise and other person. Article 21 Director of enterpriseDirector of enterprise is the main responsible person of pharmaceutical goods’ quality, who prehensive responsible to the daily management of the enterprise. In order to ensure the enterprise plete quality target and manufacture pharmaceutical goods according to this Regulation, the director of enterprise shall take responsible for providing necessary resources, reasonable plan, organize and correspond to ensure the quality management department could take its responsibility independently.Article 22 Director of manufacturing managementI. Qualification:Director of manufacturing management shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least three years’ pharmaceutical goods’ manufacturing and quality management experience, including at least one year’s pharmaceutical goods’ manufacturing management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1. Manufacture and storage the pharmaceutical goods according to approved technology procedure in order to ensure the quality of the pharmaceutical goods。5. Ensure all kind of necessary validation work is pleted。4. Approve quality standard, sampling method, inspection method and other operation proceduress of quality management。8. Supervise the maintenance of workshop and equipment in order to maintain its good working condition。12. Ensure all plaints related to product quality have been researched, and have been dealt with in time and accurately。II. Supervise the sanitation condition of factory。VI. Approve and supervise consigned manufacture。X. Monitor the factors influence the quality of the products.Article 25 Authorized person of qualityI. Qualification:Authorized person of quality shall at least have pharmacology or related specialty undergraduate education background (or secondary professional technical title or licensed pharmacist qualification), have at least five years’ pharmaceutical goods’ manufacturing and quality management experience, have the experience of manufacturing process control and quality check work. Authorized person of quality shall have necessary professional theory knowledge, have taken part in the train about product delivering, and could take his responsibility independently.II. Main responsibility:1. Take part in the establishment of enterprise quality system, interior selfcheck, exterior quality audit, validate and pharmaceutical goods’ bad reaction report, product re