This study aims to explore and implement the construction of a pharmaceutical microbiology quality control laboratory compliant with World Health Organization (WHO) standards. By integrating WHO regulations, guidelines, and ISO/IEC 17025 quality management system requirements, the compliance construction focus on critical aspects such as personnel management, analytical procedure verification, validation, record, data integrity, change control, and deviation investigation. Practical implementation demonstrates significant improvements in the laboratory’s quality management system, data integrity, and international recognition, confirming the high operability and practicality of the proposed approach. This methodology provides a valuable reference for optimizing the quality management system in pharmaceutical microbiology testing laboratories and supports the international mutual recognition of drug testing results in China.

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