Module 1: Introduction
Chapter 1: Overview of Drug Operation Quality Management
Section 1: Drug Quality and Drug Quality Supervision and Administration
I. The Special Characteristics of Drugs
II. Quality and Drug Quality
III. Legislation on Drug Quality Management
Section 2: Overview of Good Practice in Pharmaceutical Business
I. The formation process of GSP
II. The significance and role of the implementation of GSP
III. The main content of GSP
IV. The guiding ideology of GSP
V. The basic principles of GSP
Section III: Implementation of GSP
I. Implementation of GSP
II. Matters
Chapter II: Laws and regulations related to quality management of drug business
Section I: The Law of the People's Republic of China on Drug Administration and its Implementing Regulations
I: General Provisions of the Law of the People's Republic of China on Drug Administration
II: Management of Drug Business Enterprises
III: Management of Pharmaceuticals in Medical Institutions
IV: Management of Drug Prices and Advertisements
V. Drug Pricing and Advertisement Management
V. Supervision and Administration of Drugs
Section 2: Other Relevant Laws and Regulations on Quality Management of Drug Business
Practical Training I: Visiting Drug Retail Enterprises
Practical Training II: Visiting Drug Wholesale Enterprises
Module II: Management of Drug Incoming Goods
Chapter III: Quality Management Personnel and Institutions of Drug Business
Section III: Quality Management Personnel and Institutions of Drug Business< /p>
Section 1: Requirements of GSP on personnel
I. Requirements of GSP on personnel of drug wholesalers
II. Requirements of GSP on personnel of drug retail chain enterprises
III. Requirements for Institutions
II. Requirements for Institutions of Drug Retail Chain Enterprises under GSP
III. Requirements for Institutions of Drug Retail Enterprises under GSP
Section III Training and Health Examination of Personnel
I. Training and Education
II. Health Examination
Practical Training III Simulation of Recruitment
Practical Training IV. Quality Leadership Organization
Chapter 4: Management of Drug Purchase
Section I: Principles and Procedures of Drug Purchase
I. Principles of Drug Purchase
II. Basic Methods of Drug Purchase
III. Factors Affecting Drug Purchase
IV. Steps of Drug Purchase
Section II: Drug Purchase Plan Management
I. Principles of Preparation of Drug Purchasing Plan
II. Basis of Preparation of Commodity Purchasing Plan
III. Methods of Preparation of Commodity Purchasing Plan
Section III: Selection of Supplier
I. Requirements of Supplier
II. Principles of Selection of Supplier
III. Supplier Optimization and Elimination
I. Role of Economic Contracts
II. Principles and Requirements for Signing Economic Contracts
III. Negotiation of Drug Purchase Contracts
IV. Basic Contents of Purchase Contracts
V. Quality Clauses in the Contracts
VI. Contract Management and Enforcement
Section V: Drug Quality The division of responsibility and treatment of problems
I. The responsibility and treatment of the supply side
II. The responsibility and treatment of the purchasing side
Section VI: Operation of new varieties
I. Operation of new drugs
II. Incoming process operation
Module 3: Drug Storage and Maintenance
Chapter V Facilities and Equipment
Section 1: Warehouses and Warehouse Facilities and Equipment
I. Classification of Warehouses
II. Selection of Warehouses for Overall Environment
III. Layout of Warehouse Areas
IV. Section 2: Inspection and Maintenance Equipment
I. Facilities and Equipment of Acceptance and Maintenance Places
II. Facilities and Equipment of Inspection Places
III. Laboratory
IV. Acceptance and Maintenance Rooms
Section 3: Facilities and Equipment of Pharmaceutical Retail Enterprises
I. Warehouses
Third, facilities and equipment
Training VI Facilities and equipment to be provided and managed in warehouses
Chapter VI Acceptance and warehousing
Section 1 Acceptance and procedures
I. Acceptance
I. Acceptance
II. Contents of acceptance
II. Contents of acceptance of returned products
III. Contents of acceptance of imported medicines
Section III: Acceptance management
I. Management of acceptance records
II. Handling of acceptance-related issues
Section IV: Stocking of medicines
I. Stocking procedures
II.
Third, the acceptance of the acceptance of personnel refused to accept
Training VII Acceptance of packaging, labeling, instructions
Chapter VII Storage and Maintenance Management
Section 1: Drug Storage Management
I. Basic Requirements for Handling and Stacking of Drugs
II. Drugs Storage Color Coding Management
III. Fourth, the control of drug storage conditions
Section 2: Drug maintenance management
I. Drug maintenance content
II. Drug maintenance methods
III. Drug maintenance files and information
IV. Analysis and treatment of unqualified drugs
Section IV: The inspection and issuance of drugs
I. Principles and requirements of inspection and issuance of drugs
II. Basic procedures of inspection and issuance of drugs
Practical training VIII: Stacking of drugs
Practical training IX: The use of thermo-hygrometer and the recording of temperature and humidity in the storage room and the measures to be taken
Practical training X: Inspection of drugs in stock
The inspection of drugs in stock
It is a good idea to check the quality of drugs in the storage room. Inventory of medicines
Practical training XI Handling of medicines out of the warehouse
Module IV: Management of drug sales
Chapter VIII: Management of drug advertisements and publicity
Section 1: Examination of advertisements of medicines
I. Scope of examination of advertisements of medicines and examining authorities
II. Examination Procedures
Section 2: Advertising of Drugs
I. Supervisory and Regulatory Authorities for Advertising of Drugs
II. Media for Advertising of Drugs
III. Management of Advertising of Drugs
Chapter IX: Management of Special Drugs
Section 1: Management of Narcotic Drugs and Psychotropic Substances
I, Definition and Variety Scope of Narcotic Drugs and Psychotropic Substances
II. Management of Narcotic Drugs and Psychotropic Substances
III. Management of Storage and Transportation of Narcotic Drugs and Psychotropic Substances
Section II. Management of Toxic Substances for Medical Purposes
I. Definition and Classification of Toxic Substances for Medical Purposes
II. Management
Section 3: Management of Radiopharmaceuticals
I. Definition of Radiopharmaceuticals
II. Management of the Operation of Radiopharmaceuticals
III. Management of the Packaging and Transportation of Radiopharmaceuticals
Chapter 10: Sales and After-sales Service
Section 1: Sales Management
I. Management of the Sales of Pharmaceutical Wholesalers
II.
II. Sales Management of Pharmaceutical Retail Enterprises
Section 2: Transportation Management
I. Transportation Management of Pharmaceuticals
II. Pharmaceutical Distribution Management of Retail Chain Enterprises
Section 3: After-sales Service
I. Survey of Customers' Opinions
II. Adverse Reaction Monitoring System
I. National Regulations on Adverse Drug Reaction Monitoring
II. What is Adverse Drug Reaction
III. Adverse Drug Reaction Reporting System
Practical Training XII. Drug Sales Management Skills
Module 5: Comprehensive Quality Management
CHAPTER 11 COMPREHENSIVE QUALITY MANAGEMENT
The following is a brief introduction to the topic. Section I: Management of quality policy objectives
I. Formulation of quality policy objectives
II. Basic principles of quality policy objectives
III. Implementation of quality policy objectives
IV. Inspection and assessment of quality policy objectives
Section II: Quality management document system
I. Overview of quality management document system
II.
II. Principles of Establishing a Quality Management Documentation System
III. Types of Quality Management Documentation System
IV. Main Contents of the Quality Management Documentation System
V. Control of the Quality Management Documentation System
Section III: Inspection and Appraisal of the Quality Management Work
I. Specific Contents of the Appraisal
II, Procedures and methods of assessment
Third, measures and improvement
Practical Training XIII Preparation of Quality Management Documents
Appendix
References
Objective Testing Reference Answer
Pharmaceutical Quality Management Syllabus