GMP 英文版 China_(revised_in_2010)(MOH_Decree_No[1]._79)-EN.doc

Good Manufacturing Practice for Pharmaceutical Products(Amended in 2010) SDA Order #79Order by Ministry of Health of the Peoples Republic of ChinaPublished on February 12, 2011 No. 79Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) has passed by Affairs Meeting on October 19, 2010. This Regulation is now published and shall be effective from March 1, 2011.Director Zhu CHEN January 17, 2011Chapter 1 General ProvisionsArticle 1In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the Peoples Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the Peoples Republic of China”. Article 2A pharmaceutical enterprise shall establish pharmaceutical goods quality control system. The system shall contain all factors which may affect the quality of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods quality in accordance with intending purpose. Article 3This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products. This Regulation aims to reduce the risks in pharmaceutical goods manufacturing process at its maximum, such as pollution, cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements.Article 4The enterprise shall obey this Regulation strictly, insist on honesty and keep faith, prohibit any ostensible and spurious activities.Chapter 2 Quality Control Section 1 PrincipleArticle 5The enterprise shall establish quality target in accordance with pharmaceutical goods quality control requirements, carry out all requirements related to safety, effective and quality control into the process of pharmaceutical goods manufacturing, control and products discharging, storage, delivering, ensure all pharmaceutical goods are produced in accordance with intending purpose and registered requirements. Article 6Senior administrator in enterprise shall ensure the achievement of intending quality target. Personnel in different levels and provider, dealer shall participate in and take each responsibility. Article 7The enterprise shall equip adequate personnel, workshop, establishment and equipment in accordance with requirements, and provide essential condition for achieving quality target.Section 2 Quality GuaranteeArticle 8Quality guarantee is a part of quality control system. The enterprise must establish quality guarantee system, and establish integrate document system at the same time, in order to ensure the systems effective running. Article 9Quality guarantee system shall ensure the following: I.Represent the requirements of this Regulation in pharmaceutical goods design and development.II.In accordance with the requirements of this Regulation in manufacturing management and quality control activities;III.Specific management responsibility;IV.Exact stocked and used raw material and wrapper;V.Effective control in semifinished product;VI.Implement of confirmation and validation;VII.Manufacture, examine, inspect and double examined according to rules strictly;VIII.Each batch of products shall only discharge after quality authorizing persons approval;IX.Applicable measures to ensure pharmaceutical goods quality during the process of storage, delivering and all succedent operation process;X.According to self-examine rules, examine and evaluate the validity and applicability of the quality guarantee system quality.Article 10Basic requirements of pharmaceutical goods manufacture quality management:I.Frame manufacturing technique, systemic review and demonstrate it could continuous stably manufacturing products in accordance with requirements;II.Manufacturing technique and its important changes shall be validated;III.Equip all required resources, include, but not limited the following:1.Hold applicable qualification and the eligible trained personnel;2.Adequate workshop and space;3.Applicable equipment and maintain guarantee;4.Accurate raw material, wrapper and label;5.Approved technique rules and operate rules;6.Applicable storage and freight condition.IV.Use accurate and easy understand language to frame operate rules;V.The operate person could accurate operate according to operate rules after training;VI.The whole manufacture process shall be recorded. The windage shall be researched and be recorded;VII.Batch record and delivering record shall be traced back to the whole history of the batch of products, and the records shall be saved appropriately and be easy consult;VIII.Reduce the quality risk during the pharmaceutical goods delivering process;IX.Establish pharmaceutical goods recall system, and ensure any batch delivered and sold products could be recalled;X.Survey the reasons leading to pharmaceutical goods complaints and quality objections, take measures to prevent similar quality objections.Section 3 Quality ControlArticle 11Quality control includes corresponding organization, document system and sampling, test and so on, to ensure material or products finish necessary examination before delivering, and to verify its quality is in accordance with the requirements.Article 12Basic requirements of quality control:I.Equip applicable establishment, equipment, instrument and trained personnel to effective and reliable finish all related quality control activities;II.Have approved operate rules, which used to sampling, examine, inspect raw material, wrapper, semifinished product, bulk product and finished product and products stability, monitor environment when necessary, to ensure the products is in accordance with the requirements of this Regulation;III.Authorized person shall sampling to raw material, wrapper, semifinished product, bulk product and finished product according to stated methods;IV.Inspect methods shall be confirmed and validated;V.Sampling, check, inspect shall be recorded, the windage shall be researched and be recorded;VI.Material, semifinished product, bulk product and finished product shall be checked and inspected according to quality standard and be recorded;VII.Material and packaged finished product shall have enough reserved samples so that necessary check or inspect shall be taken; 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 13Quality risk management is evaluate, control, communicate, audit system process to quality risk during the whole product life period, via the manner of foresee or review.Article 14Quality risk shall evaluate according to science knowledge and experience in order to ensure products quality.Article 15The method, measure, form take during the quality risk management process and the documents formed in the said process shall accommodate to the level of the existent risk. Chapter 3 Organization and Personnel Section 1 PrincipleArticle 16An enterprise shall establish management organization which accommodate 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 17Quality 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 18The 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. Stations 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 pre-job training and on-job training.Article 19Generally, 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 20The important person shall be the full-time 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 21Director of enterpriseDirector of enterprise is the main responsible person of pharmaceutical goods quality, who comprehensive responsible to the daily management of the enterprise. In order to ensure the enterprise complete 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 22Director 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 years 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;2.Ensure every operation proceduress related to manufacturing operation are performed strictly;3.Ensure batch production record and batch package record are audited by designated person and submitted to quality management department;4.Ensure the maintenance of workshop and equipment in order to preserve its good working condition;5.Ensure all kind of necessary validation work is completed;6.Ensure person related to manufacturing have been trained by pre-job training and on-job training, adjust training content according to actual demands.Article 23Director of quality managementI.Qualification:Director of quality management 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, including at least one years pharmaceutical goods quality management experience, have taken part in professional knowledge training related to manufacturing products.II. Main responsibility:1.Ensure the raw material, wrapper, semifinished product, bulk product and finished product are in accordance with the registered approved requirements and quality standard;2.Ensure the products are audited to batch record before delivering;3.Ensure necessary inspection is finished;4.Approve quality standard, sampling method, inspection method and other operation proceduress of quality management;5.Audit and approve all changes related to quality;6.Ensure all important windage and exceed criterion inspection results have been researched and been dealt with in time;7.Approve and supervise consigned inspection;8.Supervise the maintenance of workshop and equipment in order to maintain its good working condition;9.Ensure to finish every necessary confirmation and validation work, checking and approving confirmation or validation scheme and report;10.Ensure to finish self-check;11.Evaluate and approve material supplier;12.Ensure all complaints related to product quality have been researched, and have been dealt with in time and accurately;13.Ensure to finish products persistent stability review plan, provide the data of persistent stability review;14.Ensure to finish product quality review analysis;15.Ensure quality control and quality guarantee person have been trained by pre-job training and on-job training, adjust training content according to actual demands.Article 24Director of manufacturing management and director of quality management often have the following common responsibility:I.Audit and approve the documents of products technology procedure, operation proceduress;II.Supervise the sanitation condition of factory;III.Ensure the key equipment have been confirmed;IV.Ensure to finish the validation of production technology;V.Ensure all related person in enterprise been trained by pre-job training and on-job training, adjust training content according to actual demands;VI.Approve and supervise consigned manufacture;VII.Ensure and monitor the storage condition of material and goods;VIII.Save the record;IX.Supervise the implement condition of this Regulation;X.Monitor the factors influence the quality of the products.Article 25Authorized 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 self-check, exterior quality audit, validate and pharmaceutical goods bad reaction report, product recall and other quality management activities;2.Take the responsibility of product delivering, to ensure the manufacturing, checking of every batch of delivered products are all in accordance with corresponding code, pharmaceutical goods registered requirements and quality standard;3.Before delivering the products, authorized person of quality must issue product delivering audit record according to the said item 2 and bring it into batch record.Section 3 TrainingArticle 26The enterprise shall designate department or person to take responsible for training management work, and shall have the training scheme or plan audited or approved by director of manufacture management or director of quality management. The training record shall be preserved.Article 27All personnel related to pharmaceutical goods manufacturing, quality shall be trained, the training content shall accommodate to the post. Except the training of theory and practice of this Regulation, responsibility, skill training about the related code, relevant post shall also be trained, and actual effect shall be periodic evaluated.Article 28The working person in high risk operating area (such as: manufacture area of high activity, high toxic, infective, high sensitive material) shall take expert training.Section 4 Personnel SanitationArticle 29All personnel shall take sanitation requirements training, the enterprise shall establish personnel sanitation operation proceduress, so that to reduce the pollution risk to pharmaceutical goods taken by person at its maximum.Article 30Personnel sanitation operation procedures shall include the content related to health, sanitation practice and personnel dress. Personnel in manufacturing area and quality control area shall correctly understand related personnel sanitation operation procedures. The enterprise shall take measures to ensure the implement of personnel sanitation operation procedures.Article 31The enterprise shall manage personnels health and establish health file. The manufacture personnel contact pharmaceutical goods directly shall receive physical check, and take at least one physical check per year.Article 32The enterprise shall take appropriate measure to avoid the person have wound in body surface, have infection disease or other person may pollute pharmaceutical goods to take the manufacture work which directly contact pharmaceutical goods. Article 33Visiting person and untrained person shall not enter manufacture area and quality control area, if the persons need to enter in special conditions, the items of their individual sanitation, clothes changing and so on shall be instructed.A