GB/T 44651.2-2025Implementation guidances for knowledge management — Part 2: Pharmaceutical industry (English PDF)

0.1 Overview

The pharmaceutical industry is a strategic industry that is related to the national economy and people's livelihood, economic development and national security, and is an important foundation for the construction of a healthy China.

R&D innovation is difficult, has a long cycle, high investment, and is knowledge-intensive. It is a typical high-tech industry. Knowledge management in the pharmaceutical industry runs through the pharmaceutical industry.

The pharmaceutical industry directly affects the development of life and health.

In order to promote the high-quality development of the pharmaceutical industry based on innovation, pharmaceutical companies It is necessary to implement knowledge management and plan and manage relevant knowledge resources and knowledge activities. ICHQ10 clearly states that pharmaceutical companies’ knowledge Knowledge management is one of the driving forces behind the development of an enterprise's quality system. As a special commodity, medicines are closely related to people's life and health.

The life cycle is long, including the process of drug research and development, registration evaluation, marketing, re-evaluation, and delisting.

The knowledge management level of production, operation, circulation and other links is closely related to the quality of drugs.

Develop and utilize the data and experience in the process, fully explore and discover knowledge, guide production and operation, assist decision-making, and promote organizational structure and business Optimize processes, improve management systems, and promote enterprise transformation, transformation and upgrading.

0.2 Process Approach

This document aims to promote technological innovation and value creation in the pharmaceutical industry.

Part 1: Under the guidance of the Guidelines, the ideas and methods for pharmaceutical companies to carry out knowledge management work are proposed, in product research and development, commercial production, market In each link of marketing, operation guarantee, etc., we plan and manage the activities of knowledge identification, creation, acquisition, storage, sharing, and application, and comprehensively Use emerging knowledge management technologies to spread the pursuit of continuous improvement and innovation awareness within the organization, and promote the organization's innovation capabilities and Improved competitiveness.

GB/T 44651 "Guidelines for the Implementation of Knowledge Management" aims to provide guidance for the implementation of knowledge management systems in different industries.

It consists of the following parts.

— Part 1: Equipment manufacturing industry. The purpose is to provide a general framework, methods and construction guidelines for knowledge management in the manufacturing industry.

— Part 2: Pharmaceuticals. Aims to provide a general framework, methods and construction guidelines for knowledge management in the pharmaceutical industry.

— Part 3: Electricity. The purpose is to provide a general framework, methods and construction guidelines for knowledge management in the power industry.

Knowledge Management Implementation Guide Part 2: Pharmaceuticals

3.1 knowledge

Knowledge, judgment or skills acquired through learning, practice or exploration.

[Source. GB/T 23703.2-2010, 2.1]

3.2 knowledge management

Activities for planning and managing knowledge, the knowledge creation process and the application of knowledge.

[Source. GB/T 23703.2-2010, 2.9]

3.3 knowledgebase/repository

The collection of domain knowledge required to solve the problem, expressed as basic facts, rules and patterns organized into procedures, used for the relevant domain knowledge Capture, store, and share.

[Source. GB/T 23703.2-2010, 4.6]

3.4 Industry expert subject matter expert; SME

An expert who is proficient in a particular field or subject.