The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

The purpose of this study was to investigate the warming temperature and exposed time on the post-thaw survival rate and viability of bovine blastocyst cryopreserved by GMP vitrification. Groups of three bovine IVP blastocysts were sequentially placed into vitrification solution before being loaded into the GMP straws and immersed into LNwithin 20 to 25 sec. The warming rate was increased 2 times of warming temperature for improvement of post-thaw survival rates. The frozen embryos were warmed either at 35 or 70 for 1 or 2 sec and then diluted in sucrose solution. Post-thaw blastocysts were serially washed in 0.25 and 0.15 M sucrose in holding medium (HM: TCM199 supplemented with 10% FCS) and TCM-199 for each 5 min, respectively, and then cultured in TCM199 for 24 h. The rate of re-expanded blastocyst was significantly different fer 35 and 70 warming temporature (76.4 vs. 89.3%; P<0.05). The rate of re-expanded blastocyst at 70 for 1 sec was significantly higher than that for 2 sec (91.1 vs. 70.9%; P<0.05). The number of nuclei counted were significantly different among control, 35 and 70 (1218.5 vs. 10411.7 vs. 11410.3; P<0.05). These results indicated that the increasing of warming rate can provide high survival rates of bovine IVP blastocysts. Especially, the best viability of post-thaw blastocyst could be thaw at 70 for 1 sec. The warming temperature and exposed time far warming was considered to be limiting factors to the viability of bovine IVP embryos. he purpose of this study was to investigate the warming temperature and expose.

In recent years, safety recalls have occurred frequently in the biopharmaceutical industry, which affects the health of consumers. This article attempts to use the fsQCA method to draw a conclusion through the study of ESG and its quantification system, as well as the study of data samples related to MES and GMP processes, that is, MES-DPT has a positive impact on process safety management, and GMP-DPT has a positive impact on process safety. Management has a positive and positive impact, and ESG-DPT has a positive and positive impact on process safety management. Finally, this article puts forward suggestions for improving ESG-DPT, MES-DPT, GMP-DPT and the biomedical ESG-DPT model. Future research hopes to further study ESG -DPT model and ESG biomedical industry indicators.

Intact germinal vesicle (GV) arrest and release are essential for maintaining the fertility of mammals inducing human. Intact germinal vesicle release, maturation of oocytes is maintained by very complex procedures along with folliculogenesis and is a critical step for embryonic development. Cyclic guanosine monophosphate (cGMP) has been suggested a key factor for meiotic arrest but so far its mechanisms are controversy. In this study we examine the effects of cGMP on germinal vesicle breakdown in cumulus-enclosed oocytes and denuded oocytes. Spontaneous maturation was inhibited by a cGMP agonist, 8-Br-cGMP with concentration dependent manners both in cumulus-enclosed oocytes and denuded oocytes. The inhibitory effect was more severe in denuded oocytes than cumulus-enclosed oocytes. The Rp-8-Br-cGMP and Rp-pCPT- 8-Br-cGMP did not severely block GVB compared to 8-Br-cGMP. The spontaneous GVB inhibitory effects were different by the existence of cumulus. Based on them it is suggested that the cumulus modulates the role of cGMP in GV arrest.