High-quality products are the most powerful pillar for an enterprise to gain a firm foothold in competition. Therefore, production quality management should be the most fundamental and important part of enterprise management. Pharmaceutical production quality management consists of five core elements, namely Personnel, Equipment, Materials, Processes, and Environment.
Personnel are the most crucial factor in production quality management. To effectively manage this element, the following two aspects must be well addressed:
Training is the most effective means for personnel to acquire and enhance operational skills, technical knowledge, and legal awareness. The purpose of training is to guide personnel toward positive development, enabling them to fully familiarize themselves with and master job-specific operational skills, and participate in the enterprise’s production activities better and more proactively.The main content of training should include relevant laws, regulations, and policies, corporate culture and philosophy, enterprise management systems, standard operating procedures (SOPs), and production process regulations. Training methods can take forms such as internal training, external training, and on-the-job skill drills.
Management is a key measure to curb personnel inertia and give play to their initiative, serving as a strong guarantee for completing production tasks with quality and quantity requirements on schedule. Therefore, to improve personnel management, enterprises should establish strict supervision and restraint systems as well as assessment, reward, and punishment mechanisms, and implement and assess them rigorously.
The integrity of equipment is the focus of equipment management, which means ensuring the equipment’s completeness, accuracy, stability, reliability, and original advantages through systematic management. Equipment management should be carried out in the following two ways:
To achieve proper and rational use of equipment, first, qualified operators must be assigned. Operators should not only fully understand and master the equipment’s structure, performance, and maintenance knowledge but also abide by the management principle of "who uses, who manages, who is responsible."Second, it is necessary to ensure that the equipment operates under safe operating conditions. Each piece of equipment has its safe operating parameters; exceeding these parameters will not only easily lead to accidents but also reduce the equipment’s operational accuracy, affecting product quality.
To do this well, managers must conduct daily maintenance and regular inspection in strict accordance with equipment maintenance and upkeep procedures to identify potential safety hazards in equipment operation. In addition, each piece of equipment has its own safe operation cycle, which the management department must strictly control and monitor. For equipment that has reached its safe operation cycle, the department should promptly issue a shutdown and maintenance order. The maintenance department must conduct a comprehensive and thorough inspection and maintenance of the equipment on schedule, and replace worn parts in a timely manner to eliminate potential accidents.
The management of materials directly affects the progress, quality, and cost of pharmaceutical production and is a core content of GMP (Good Manufacturing Practice). Material management should focus on the following three aspects:
Pharmaceutical production is of a special nature: it is carried out in accordance with the variety, quality, and quantity specified in national pharmaceutical standards. Any carelessness may lead to product quality problems—at best, the product may be ineffective when taken by patients, and at worst, it may be toxic to the human body. Therefore, accurate feeding is the key to material management.During feeding, workshop material dispensers, quality inspectors, process engineers, section chiefs, and operators must conduct strict inspection and verification. If any feeding error is found, it must be reported and handled promptly to ensure the safety and efficacy of the produced pharmaceuticals.
In the pharmaceutical production process, material consumption always exists, which can be divided into three types:
- Effective consumption: With a fixed total input in production, the higher the effective consumption, the higher the product yield.
- Process-related consumption: Determined by the level of production technology, it can be gradually reduced to a minimum with the advancement of process technology.
- Non-process-related consumption: Unnormal consumption caused by poor management or improper operation, whose ideal state is zero consumption.
To address this, enterprises should establish reasonable material consumption quota indicators and conduct strict assessment; strictly control process technology to continuously improve the technological level; strengthen production scheduling management, formulate a reasonable production cycle, store materials and intermediate products in accordance with regulations, and prevent materials from being affected by moisture, mildew, leakage, etc.
Production processes are the key technologies that guide pharmaceutical production and ensure product quality. Failure to implement them correctly will make it impossible to produce qualified pharmaceuticals.
The main content of production process management is to strictly enforce process systems, conduct process inspections, and implement process supervision. Pharmaceuticals must be produced in strict accordance with the approved process regulations. All process parameters—such as feeding ratio and quantity, extraction time and frequency, and production temperature and pressure—must be strictly implemented. Workshop section chiefs, process engineers, and quality inspectors must ensure that all process parameters are implemented during production and remain under control at all times. The indicating or measuring instruments for all process parameters must be used within the specified validity period.
Another content of process management is the improvement and enhancement of processes. Although production processes are approved by national pharmaceutical regulatory authorities, there are still many uncertainties that must be studied, verified, and improved in actual production. In addition, with the advancement of science and technology, production processes should also be continuously upgraded to achieve a more advanced, stable, reasonable, and applicable level.
The pharmaceutical production environment is divided into the outdoor environment and clean production areas. As long as the outdoor environment is free from dust and unpleasant odors, it can basically ensure that the clean production areas are not affected. Therefore, clean production areas should be the focus of environmental management.
During production, the static pressure difference between adjacent rooms with different air purification levels must be greater than 5 Pascals, and the static pressure difference between indoor and outdoor air must be greater than 10 Pascals. The number of dust particles and microorganisms in the production area must be monitored regularly to meet GMP requirements.
Personnel and materials must enter and exit the production area in accordance with the specified routes, methods, and requirements. When personnel enter the production area, they must change clothes, wash hands, and disinfect to avoid bringing contaminants into the area. When materials enter the production area, their outer packaging must be cleaned, disinfected, or removed to prevent pollution to the production area.
Floor drains in the production area must be equipped with water-seal devices, and the water level pressure of the water seal must be sufficient to prevent the backflow of waste gas and wastewater. After the end of daily production, operators must clean the floor drains and seal them with disinfectant.
The inner surfaces of workshops, floors, equipment, tools, platforms, and guardrails in the production area must be cleaned regularly.
