How pharmaceutical companies carry out training

Author: Li Jun / Liu Li / Xu Jihai (editors)
Publisher:
Publishing Date: 2005-08-01
Features: How to improve the quality of human resources in pharmaceutical enterprises, how to strengthen employee training in pharmaceutical enterprises, especially enhancing GMP training centered on quality, how to genuinely transform concepts, establish scientific training concepts and mechanisms, and truly promote enterprise development—these have increasingly become hot topics of concern for China's various levels of drug regulatory authorities and pharmaceutical enterprises. Based on the theory of modern training and development, this book combines practical situations in China's pharmaceutical production enterprises, focusing on GMP training as the main thread to discuss the theoretical and practical aspects of how pharmaceutical enterprises can carry out training, and provides a GMP training question bank. This book can be used for training in pharmaceutical enterprises and also serves as a reference for drug regulatory personnel at all levels.
[Preface]
How to improve the quality of human resources in pharmaceutical enterprises, how to strengthen employee training in pharmaceutical enterprises, especially enhancing GMP training centered on quality management, how to genuinely transform concepts, establish scientific training concepts and mechanisms, and truly promote enterprise development—these have increasingly become hot topics of concern for China's various levels of drug regulatory authorities and pharmaceutical enterprises.
Within the larger system of human resources, talent is the primary strategic issue, as it relates to the entire strategic economic development. Research on talent strategy must not only focus on the design of education and training systems and mechanisms but also analyze the dynamics between knowledge economy production relations and productivity. The pharmaceutical industry is a high-tech industry (where science and technology are productivity), requiring scientific management methods such as GMP and TQM to ensure product quality. Not only does GMP stipulate that employees must undergo GMP and professional technical training, but corporate culture and the three major management system standards also emphasize that education and training for all members of the organization are indispensable for the success of this management approach.
After China's pharmaceutical enterprises have undergone rounds of mandatory GMP certification, looking back from the location of July 1, 2004, and forward to the future, there is indeed a strong sense of confidence, seeing the prospects and responsibilities of advancing toward a pharmaceutical powerhouse. Through GMP certification, the pharmaceutical industry has improved its overall level and achieved phased results, with initial adjustments in the structure of pharmaceutical enterprises and product structures, as well as some improvement in product quality and employee quality. However, it is far from accomplished, as there is still a certain distance to cover compared to advanced current GMP standards worldwide. Industry insiders believe that enhancing personnel quality awareness and strengthening GMP-centered training are the urgent priorities for China's pharmaceutical enterprises.
This book was written and published in this context to meet the training needs of China's pharmaceutical enterprises. How can pharmaceutical enterprises carry out training? This requires a deep understanding of the essence of GMP, implementing the three goals of GMP (preventing errors, preventing contamination, and strengthening quality management)—oriented toward customer satisfaction—as well as perfecting the three key elements of GMP (hardware, software, and "wet ware" or personnel)—with training in the three software elements (hygiene, validation, and documentationization) as a breakthrough. By putting people first, continuously improving employee quality, and continuously inspiring their sense of initiative, with a proactive and serious attitude, as well as rich and effective knowledge and proficient skills, pharmaceutical enterprises can strengthen quality management in drug production, perform their duties well, and exchange excellent work quality for superior product quality.
From a macro and micro perspective, as well as from the connotation and extension of GMP, it is also necessary to establish a "big quality" concept, vigorously promote total quality management (TQM), and strive to create learning organizations, continuously strengthening the pharmaceutical quality assurance system. This requires Chinese pharmaceutical enterprises to increase investment in intellect and training, ensuring employees have a solid knowledge base, skilled operational skills, and a conscientious work attitude. For this purpose, this book explores these aspects.
In terms of writing, this book strives to combine systematic and innovative content with theory and practice. To aid understanding, the content follows an ordered narration method, summarized as follows:
First, it emphasizes the central focus of pharmaceutical enterprise training—GMP training—as well as the importance of having a sound training management system.
Second, it recommends two training models for pharmaceutical enterprises in terms of content, which are essentially quality management models and should be localized based on the enterprise's actual situation. Pharmaceutical enterprises must not only value product quality but also value the quality of drug producers (employees), achieving a win-win situation through training.
Third, it emphasizes the three aspects of employee training (knowledge, skills, and attitudes), stresses training in China's current three major management system standards (QMS, EMS, OHSMS), and introduces the Deming Quality Management Trilogy.
Fourth, it elaborates on four levels of corporate culture that cannot be ignored in training content (material culture, behavioral culture, institutional culture, and spiritual culture), as well as the four pillars of TQM (customer satisfaction, systems/processes, human resources, and improvement tools), and the four components of the employee training system (training needs analysis, training design and procurement, training implementation, and training evaluation).
Fifth, it introduces five skills or disciplines for building learning organizations (self-transcendence, improving mental models, establishing a shared vision, team learning, and systems thinking), as well as recognizing the importance of improving quality through 5S management training (sort, set in order, shine, standardize, sustain).
Sixth, it introduces the training experience of 6Sigma management to inspire pharmaceutical enterprises to play a leadership role in training, recognize the importance of full participation, and emphasize the necessity of black belt training for middle-level managers.
Seventh, it emphasizes the foundational training for pharmaceutical enterprise quality management groups (QCC), which should master both the old and new seven statistical tools for improvement.
Eighth, it repeatedly stresses that training in the eight quality management principles is indispensable.
In the end, people come first; the ten principles must be applied well in training. As the saying goes: "Ten years to grow trees, a hundred years to raise people." For pharmaceutical enterprises, pursuing the perfection of quality is the goal and a long-term plan. Only by combining theory with practice can training be done well and GMP be perfected. For China's pharmaceutical enterprises, how to further accelerate the research and development of new products and create more attractive quality is a new challenge facing them at present. The charm of quality characteristics is a new concept and theory. Quality management experts, based on the relationship between different types of quality characteristics and customer satisfaction, classify major quality characteristics into two categories: must-be characteristics and charm characteristics.
Must-be characteristics refer to those that, even if fully provided, do not make customers feel particularly excited or satisfied, but once insufficiently provided, cause strong dissatisfaction. Charm characteristics refer to those that, if fully provided, bring satisfaction, but if insufficiently provided, do not cause dissatisfaction.
To pursue the perfection of product quality, pharmaceutical enterprises cannot do without training. In summary, this book, with scientific quality management (including GMP) training as the main thread and a combination of theory and practice, introduces some principles of training and development in human resource management to pharmaceutical enterprises. We sincerely hope that pharmaceutical enterprises, using GMP management and training as a means, can gradually strengthen quality-centered management, grow bigger, stronger, and more enduring, maintain their youthful charm, and make greater contributions to the cause of human health.
This book is written by absorbing and learning from modern training and development theory and combining it with the practice of GMP training in China's pharmaceutical enterprises. Due to the authors' limited expertise, omissions and errors in the book are inevitable. We sincerely appreciate the guidance of experts and readers.