ABSTRACT
Nanomaterials appear to be promising for a number of applications in in-vitro diagnostics, mainly due to the biocompatibility, specific surface and conduction activity. The use of nanostructures as diagnostic tools has the advantage of very low limit of detection achievable, high sensitivity, strong selectivity and the possibility to fabricate point-of-care diagnostic devices. With the problems of nanotechnology solved, nanomaterials had already put a broad impact in the field of clinical medical examination.
Subject(s)
Nanostructures , NanotechnologyABSTRACT
OBJECTIVE:To provide references for the improvement of our country's current Good Manufacturing Practice(GMP).METHODS:In consideration of GMP standards and problems in its implementation,the system,customers,suppliers,business leaders and documentation etc.were analyzed.RESULTS&CONCLUSION:Problems in the GMP standards has influenced the practice of GMP.In order to improve and optimize the GMP standards,it was recommended that process system be integrated to make the design quality in conformity with the manufacturing quality,open quality management system be established,business leader's leading effect be emphasized and clear and universal documentation system be established.
ABSTRACT
OBJECTIVE:To provide approaches and avenues for the Chinese drugs preparations manufacturers in the GMP depuratory authentication.METHODS:The features and difficulties in the GMP depuratory authentication of the Chinese drugs preparations such as the optimizing of depuratory regulations,the determination of the acceptable standards,the choice of testing methods,clarification of expiration date and re-authentication were analyzed.RESULT&CONCLUSION:The depuratory regulations of the manufacturing facilities for the Chinese drugs preparations must be optimized.