Basic Training Materials for QC Teams in the Pharmaceutical Industry

Author: China Association for Quality Management in Pharmaceutical Industry
Publisher:
Publish Date: 2003-08-01
Features: Unlike general teaching reference books, this book has unique professional characteristics:
① It integrates GMP, GSP, and QC small group activities into one system, systematically introducing the basic knowledge of QC small groups. The system described is derived from the practice of pharmaceutical enterprises, making it highly operational and suitable for enterprises to refer to when implementing GMP and related regulations;
② It specially includes chapters on "Innovative QC Small Groups," reflecting the evolving and innovative development trajectory of QC small groups;
③ It introduces process control and process diagnosis knowledge, GMP-related professional knowledge, and the international ISO standard series, enabling readers to understand and apply advanced technologies both domestically and internationally;
④ It presents typical cases of QC small group activities in the pharmaceutical industry, as well as comprehensive evaluation principles and methods for QC small group activities, which are beneficial for improving the level of QC small group activities and enhancing the operability of this textbook. This book serves as a basic training textbook for QC small groups in the pharmaceutical industry and can also be referenced by quality assurance leaders and technical personnel at all levels in the pharmaceutical industry.
To address the challenges of joining the WTO and aligning with international standards, the pharmaceutical industry in China must prioritize improving product quality. Therefore, it is essential to adopt a "big quality" perspective, vigorously advocate and promote the in-depth implementation of total quality management (TQM), and build a drug quality assurance system. TQM is an important component of modern management science, and QC small group activities are a fundamental task in enterprise management. The purpose of QC small group activities is to improve quality, reduce consumption, and enhance economic benefits, emphasizing quality control at all levels, throughout the entire process, and across the entire system. QC small group activities are one of the most effective ways for the pharmaceutical industry to implement GMP, GSP, and other regulations, and they form a crucial foundation for ensuring the safety of public medication.
With the advent of economic integration, new technologies and business concepts are constantly emerging, and the concept of quality has undergone profound changes, shifting from "conformance quality" to "fitness-for-purpose quality." China's GMP has evolved from post-event quality inspection to implementing the principle of prevention, utilizing the theories of statistical process control (SPC) and statistical process diagnosis (SPD) to monitor the entire production process and establish a comprehensive quality assurance system (QA) that encompasses GMP and quality control (QC).
To meet the demands of the times, improve the level of QC small group activities in the pharmaceutical industry, and further support the implementation of GMP, GSP, and other regulations, the China Association for Quality Management in Pharmaceutical Industry has organized experts to write this textbook.