1、1Good 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 1
2、9, 2010. This Regulation is now published and shall be effective from March 1, 2011.Director Zhu CHENJanuary 17, 2011Chapter 1 General ProvisionsArticle 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration La
3、w of the Peoples Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the Peoples Republic of China”. Article 2 A pharmaceutical enterprise shall establish pharmaceutical goods quality control system. The system shall contain all factors which may affect the qua
4、lity of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods quality in accordance with intending purpose. Article 3 This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products.
5、 This Regulation aims to reduce the risks in pharmaceutical goods manufacturing process at its maximum, such as pollution, 2cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements.Article
6、 4 The enterprise shall obey this Regulation strictly, insist on honesty and keep faith, prohibit any ostensible and spurious activities.Chapter 2 Quality ControlSection 1 PrincipleArticle 5 The enterprise shall establish quality target in accordance with pharmaceutical goods quality control require
7、ments, 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 requireme
8、nts. Article 6 Senior 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 7 The enterprise shall equip adequate personnel, workshop, establishment and equip
9、ment in accordance with requirements, and provide essential condition for achieving quality target.Section 2 Quality GuaranteeArticle 8 Quality guarantee is a part of quality control system. The enterprise must establish quality guarantee system, and establish integrate document system at the same t
10、ime, in order to ensure the systems effective running. 3Article 9 Quality 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 managemen
11、t 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;VI
12、II. 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 validit
13、y and applicability of the quality guarantee system quality.Article 10 Basic 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. Man
14、ufacturing 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 ra
15、w 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;4VI. The whole manufactu
16、re 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 pharmace
17、utical 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
18、Quality ControlArticle 11 Quality 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 12 Basic requirements o
19、f 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
20、 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 stat
21、ed 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 rec
22、orded;5VII. 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
23、 4 Quality Risk ManagementArticle 13 Quality 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 14 Quality risk shall evaluate according to science knowledge and experience in order
24、 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 accommodate to the level of the existent risk.Chapter 3 Organization and PersonnelSection 1 PrincipleArticle 16 An enterprise shall esta
25、blish 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
26、 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 6quality mana
27、gement 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), an
28、d 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 responsibili
29、ties, be familiar with the requirements related to his responsibilities, and accept necessary training, including pre-job training and on-job training.Article 19 Generally, one shall not relegate his responsibility to other person. If the responsibilities do need to be relegated, the one should rele
30、gate his responsibility to the designated person who has equivalent qualification. Section 2 Important PersonArticle 20 The 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 m
31、anagement 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
32、 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 comprehensive responsible to
33、the daily management of the enterprise. In order to ensure the 7enterprise 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 ensur
34、e 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 tec
35、hnical 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 man
36、ufacturing 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. Ens
37、ure 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. Ens
38、ure person related to manufacturing have been trained by pre-job training and on-job training, adjust training content according to actual demands.Article 23 Director of quality managementI. Qualification:Director of quality management shall at least have pharmacology or related specialty undergradu
39、ate education background (or secondary professional technical title or licensed 8pharmacist 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
40、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 audite
41、d 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 criterio
42、n 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 an
43、d 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 stab
44、ility 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.9Article 24 D
45、irector 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 c
46、onfirmed;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 stora
47、ge 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 25 Authorized person of qualityI. Qualification:Authorized person of quality shall at least have pharmacology or rela
48、ted 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 wor
49、k. 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;102. Take the responsibility of product delivering, to ensure the manufacturing, checking of every batch of delivered products are all
