【正文】 V. Ventilation of air cleanse system in the above said item II, III, IV shall take cleanse management。II. Special and independent workshop, manufacturing establishment and equipment must be used when manufacturing special character pharmaceutical goods, such as high sensitive pharmaceutical goods (. ?Penicillin) or biologics goods (. bcg vaccine or other pharmaceutical goods prepared by active microorganism). The operating area with large quantity of dust for?penicillin species pharmaceutical goods shall keep paratively negative pressure, the exhaust gas discharged to outdoor shall carry cleanse management and make it be up to the mustard. Air outlet shall be away from air inlet of other air cleanse system。IX. Supervise the implement condition of this Regulation。V. Ensure all related person in enterprise been trained by prejob training and onjob training, adjust training content according to actual demands。15. Ensure quality control and quality guarantee person have been trained by prejob training and onjob training, adjust training content according to actual demands.Article 24 Director of manufacturing management and director of quality management often have the following mon responsibility:I. Audit and approve the documents of products’ technology procedure, operation proceduress。11. Evaluate and approve material supplier。7. Approve and supervise consigned inspection。3. Ensure necessary inspection is finished。4. Ensure the maintenance of workshop and equipment in order to preserve its good working condition。VII. Material and packaged finished product shall have enough reserved samples so that necessary check or inspect shall be taken。III. Authorized person shall sampling to raw material, wrapper, semifinished product, bulk product and finished product according to stated methods。VIII. Reduce the quality risk during the pharmaceutical goods’ delivering process。6. Applicable storage and freight condition.IV. Use accurate and easy understand language to frame operate rules。2. Adequate workshop and space。IX. Applicable measures to ensure pharmaceutical goods’ quality during the process of storage, delivering and all succedent operation process。V. Effective control in semifinished product。Good Manufacturing Practice for Pharmaceutical Products(Amended in 2010) SDA Order 79Order by Ministry of Health of the People’s Republic of China　　　　　　Published 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 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the People’s Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the People’s 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 quality 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. 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 4 The 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 5 The 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 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 equipment 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 time, in order to ensure the system’s effective running. Article 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 management and quality control activities。VI. Implement of confirmation and validation。X. According to selfexamine rules, examine and evaluate the validity 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。3. Applicable equipment and maintain guarantee。V. The operate perso