Chapter I Overview of Quality Management of Pharmaceutical Trading

Section 1 Drug Quality and Drug Quality Supervision and Administration

First, the particularity of drugs.

Second, quality and drug quality

Three, drug quality management legislation

Part II: Overview of "Quality Management Standards for Pharmaceutical Trading"

First, the formation process of GSP

Second, the significance and role of implementing GSP

III. Main contents of GSP

Fourth, the guiding ideology of GSP.

Verb (abbreviation of verb) Basic principles of GSP.

Section III Implementation of GSP

I. Implementation of the GSP

Second, the implementation of the GSP key issues

Chapter II Relevant Laws and Regulations on Quality Management of Pharmaceutical Trading

Section 1 "Drug Administration Law of People's Republic of China (PRC)" and its implementing regulations

I. General Provisions of the Drug Administration Law of People's Republic of China (PRC)

Two. Management of pharmaceutical trading enterprises

Third, the drug management of medical institutions

Fourth, drug prices and advertising management.

Verb (abbreviation of verb) drug supervision and management

Section 2 Other relevant laws and regulations on the quality management of pharmaceutical trading

Practice 1 Visiting pharmaceutical retail enterprises.

Practice 2: Visiting pharmaceutical wholesale enterprises

Module 2: Drug Procurement Management

Chapter III Personnel and Institutions for Quality Management of Pharmaceutical Trading

Section 1 GSP Requirements for Personnel

First, GSP's requirements for personnel of pharmaceutical wholesale enterprises

Second, GSP's requirements for personnel of pharmaceutical retail chain enterprises

Third, GSP's requirements for personnel of pharmaceutical retail enterprises

Section 2 GSP's Requirements for Institutions

First, GsP requirements for pharmaceutical wholesale enterprises and institutions

Second, GSP requirements for pharmaceutical retail chain enterprises

Three, GSP requirements for pharmaceutical retail enterprises and institutions

Section 3 Personnel Training and Health Examination

I. Training and education

Second, the health examination

Training 3 Simulated Recruitment

Training of quality leading institutions in pharmaceutical wholesale enterprises Ⅳ

Chapter IV Drug Procurement Management

Section 1 Principles and Procedures of Drug Procurement

First, the principle of drug procurement

Second, the basic way of drug procurement

Third, the factors that affect drug procurement.

Fourth, the procurement steps of drugs

Section 2 Management of Drug Purchase Plan

First, the principle of drug procurement plan

Second, the basis of commodity procurement plan

Third, the preparation method of commodity procurement plan

Section III Selection of Suppliers

I. Supplier requirements

Second, the principle of supplier selection

Third, the optimization and elimination of suppliers

Section IV Negotiation and Signing of Contracts

First, the role of economic contracts

Two. Principles and requirements for signing economic contracts

Three. Negotiation of drug purchase contract

Four, the basic content of the purchase contract

Verb (abbreviation of verb) quality clause of the contract

Management and implementation of intransitive verb contract

Section 5 Division of responsibilities and handling methods for drug quality problems

I. Supplier's responsibilities and handling methods

Second, the buyer's responsibility and handling methods

Section 6 New Variety Management

I. Management of new drugs

Two, the new drug management should have the conditions

Three, the first camp variety audit and management

Practice five drug procurement process operation

Module 3: Drug Storage and Maintenance

Chapter V Facilities and Equipment

Section 1 Warehouse and Warehouse Facilities and Equipment

I. Classification of warehouses

Second, the choice of the overall environment of the warehouse

Third, the layout of the reservoir area

Four, warehouse facilities and equipment

V. Packaging of Chinese Herbal Pieces

Section 2 Inspection and Maintenance of Equipment

A, maintenance site facilities and equipment acceptance

Second, the inspection site facilities and equipment

Third, the laboratory.

Fourth, the acceptance of the maintenance room

Section 3 Facilities and Equipment of Pharmaceutical Retail Enterprises

The first is the warehouse.

Second, the business premises

Three. Facilities and equipment

Six, the training warehouse should be equipped with facilities, equipment and management personnel.

Chapter VI Acceptance and Storage

Section 1 Acceptance Methods and Procedures

First, the acceptance method

Second, the acceptance procedures

Section II Acceptance Contents

I. Contents of drug acceptance

Second, the content of the return acceptance

Three. Contents of acceptance of imported drugs

Section 3 Acceptance Management

I. Management of Acceptance Records

Second, the handling of acceptance related issues

Section 4 Drug Storage

I. Storage Procedures

Second, the warehousing procedure

Three. Acceptance personnel refused.

Practice 7 Acceptance of Packaging, Labels and Instructions

Chapter VII Storage and Maintenance Management

Section 1 Drug Storage Management

First, the basic requirements of drug handling and stacking

Second, the color management of drug storage

Third, the classified storage management of drugs

Four, drug storage conditions control

Section 2 Drug Maintenance Management

First, the content of drug maintenance

Second, the drug maintenance methods

Three, drug maintenance files and information

Four. Effective period management of drugs

Section 3 Management of Unqualified Drugs

First, control inferior drugs.

Second, the analysis and treatment of unqualified drugs

Section 4 Delivery Inspection of Drugs

I. Principles and Requirements for Ex-factory Inspection of Drugs

Two, the basic procedures of drug factory inspection business

Exercise 8 stacking of drugs

Exercise 9: Use of Thermohygrometer and Recording and Measurement of Temperature and Humidity in Warehouse

Zhou Shi Stone checks the drugs in stock.

Exercise 11: Handling drug delivery.

Module 4: Drug Sales Management

Chapter VIII Administration of Drug Advertising and Publicity

Section 1 Drug Advertisement Examination

First, the scope of examination of drug advertisements and the examination organ

Second, the review basis of drug advertisements

Three. Review procedure of drug advertisement

Section 2 Drug Advertising

I. Supervision and administration organs of drug advertisements

Second, the media of drug advertising

Third, the management of drug advertisements

Chapter IX Management of Special Drugs

Section 1 Management of Narcotic Drugs and Psychotropic Drugs

I. Definition and types of narcotic drugs and psychotropic substances

Two. Management of narcotic drugs and psychotropic drugs

Three, the storage and transportation management of narcotic drugs and psychotropic drugs

Section 2 Management of Toxic Drugs for Medical Use

First, the definition and classification of toxic drugs for medical use

Two, the management and use of toxic drugs for medical use

Section 3 Management of Radioactive Drugs

I definition of radiopharmaceuticals

Two. Management of radioactive drugs

Three. Packaging and transportation management of radioactive drugs

Chapter X Sales and After-sales Service

Section 1 Sales Management

First, the sales management of pharmaceutical wholesale enterprises

Second, the sales management of pharmaceutical retail enterprises

Section 2 Transportation Management

I. Drug Transportation Management

Two. Drug distribution management of retail chain enterprises

Section III After-sales Service

I. Customer Opinion Survey

Second, the user quality complaints and handling

Section 4 Adverse Drug Reaction Monitoring System

I. Provisions of the State on Monitoring Adverse Drug Reactions

Second, what are adverse drug reactions?

Third, the reporting system of adverse drug reactions

Practice twelve kinds of drug sales management skills

Module 5: Total Quality Management

Chapter III XI Total Quality Management

Section 1 Management of Enterprise Quality Policies and Objectives

First, the formulation of quality policy objectives

Second, formulate the basic principles of quality policy objectives

Third, the implementation of quality policy objectives

Four. Inspection and evaluation of quality policies and objectives

Section 2 Quality Management Document System

I. Overview of Quality Management Document System

Second, the principle of establishing a quality management document system

Three, the type of quality management document system

Four, the main content of the quality management document system

Verb (abbreviation of verb) Control of quality management file system

Section 3 Inspection and Evaluation of Quality Management

First, the specific content of the assessment

Second, the evaluation procedures and methods

Third, measures and improvements

Compilation of quality management documents for practical training XIII

appendix

refer to

Target detection reference answer

Teaching outline of quality management of drug business