Core Viewpoint - The article emphasizes the importance of effective management in pharmaceutical production to minimize risks such as confusion, errors, contamination, and cross-contamination, while ensuring quality control throughout the production process [1]. Traceability Management - The revised "Pharmaceutical Administration Law of the People's Republic of China" mandates accurate, complete, and traceable information throughout the drug development, production, and usage processes [2]. - Traceability in pharmaceutical quality management is demonstrated through unique identification of materials, intermediate products, and finished products, allowing for effective tracking throughout the product lifecycle [2]. - Batch number management is a common method for establishing traceability, and the uniqueness of batch numbers is crucial for effective identification and management [2]. - Document and record traceability is essential, requiring companies to establish a quality system that encompasses all relevant documents and records related to production activities [3]. Production Process Control - Production process control strategies aim to ensure the stability of production processes and the controllability of product quality, promoting continuous improvement [4][5]. - Effective monitoring systems should be established to maintain controlled production processes, ensuring consistent quality and precise monitoring throughout the production [5]. - Quality risk management methods should be employed to develop process control strategies based on information obtained during product development and technology transfer [6]. Production Process Time Management - The "Pharmaceutical Production Quality Management Standards" specify time limits for various production processes, such as the preparation, filtration, and sterilization of liquid formulations [7]. - Management of time limits is critical, as exceeding these limits can significantly impact the quality attributes of the product [7]. Material and Product Management - Companies should establish written procedures for managing the use, distribution, and return of materials and intermediate products during production [8]. - Clear identification of materials and intermediate products is necessary to facilitate traceability and prevent the use of non-conforming products in production [8]. Contamination Control Strategies - Contamination control strategies are applicable to all drug forms and should be tailored to the specific processes and product types [9]. - Risk assessment for contamination should identify key factors affecting the production system, including facility layout, equipment, and environmental controls [9]. - A comprehensive analysis of all factors influencing the production process is essential for effective risk management and contamination control [9].