Discussion on Compliance of Complex Formulation Development Process
OBJECTIVE To provide suggestions for the compliance construction of complex formulation development processes,and promote the rationality and standardization of complex formulation development processes.METHODS Sorted out the charac-teristics and difficulties of the complex formulation development process,combined with the GMP technical requirements and verifica-tion focus,analyzed the common non-compliance situations in the complex formulation development process,and proposed compli-ance suggestions.RESULTS The development of complex formulations is often limited to excipients,instruments,pharmaceutical equipment,etc.,with high requirements for personnel quality.Innovative production processes are often adopted or new technologies are introduced into conventional production processes,and the preparation process is complex with multiple quality control parame-ters,often requiring commissioned production or inspection.Some holders of complex formulations are emerging high-tech enterprises that lack experience in full lifecycle quality management.Enterprises often experience deficiencies in key personnel training,auxilia-ry material use and changes,equipment validation,process changes,technology transfer,deviation management,commissioned re-search,and data reliability.CONCLUSION Based on the characteristics of the complex formulation product development process and the key points of registration verification,the applicant needs to strengthen quality management,ensure the scientific,reasona-ble,and standardized development process of complex formulations,and ensure the safety and quality controllability of complex for-mulations.
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