Commissioning Major Pharmaceutical Manufacturing Facilities

Author(s):  
ST Fay ◽  
TP Howard ◽  
WT Stevens
Author(s):  
Kiran Kumar Kumar Chereddy ◽  
Simon Cleveland

Pharmaceutical manufacturing facilities are complex entities that are heavily regulated by health authorities. Manufacturing sites are challenged by increased production costs, tight regulations, and heavy competition. Without a disciplined and organized management of initiatives, projects end up being terminated due to poor performance or misalignment with strategy. This study examines different types of project needs at regulated manufacturing facilities and determines how the project portfolio management processes aids the manufacturing facilities in screening and selecting projects that aid in achieving the organization's strategic goals. Moreover, the study finds not one set of criteria can fit all projects in pharmaceutical manufacturing facilities. As a result, segregation of projects into different categories and then applying funds allocation ratio and the pre-screening criteria is proposed. Finally, the study contributes new logic inputs to the screening process within the body of the program and portfolio management.


Author(s):  
Amit B Patil ◽  
Bharath Kumar B ◽  
Ajay P Karnalli

Technology Transfer (TT) is vital action from drug development in Research and Development (R and D) Department to commercial manufacturing till the product discontinuation. This review is an attempt to give an insight about the transfer of pharmaceutical product from R and D to production including necessary documents required to review the supporting documents and execution procedures in production shop floor. TT is considered effective, if there is a documented evidence that the process and its parameters, repeatedly results in desired product quality which was established upon during TT between the transferee and transferor. For the execution of TT process, expertise from different department such as Engineering, R and D, QA, process analyst and production are teamed. the transmission comprises of arrangements procured in these flows of improvement to achieve the quality as planned throughout manufacture.


Author(s):  
Neng Ria Kanita ◽  
Hendryadi Hendryadi

This study aims to examine the simultaneous and partial effects of profitability, liquidity, and firm size on capital structure. The sample is 10 pharmaceutical manufacturing companies listed in Indonesia Stock Exchange period 2012-2016, using purposive sampling. The technique of analysis used is panel data regression (pooled regression). The results showed that the selected model is the fixed effect. Simultaneously NPM, CR, and Firm Size have a significant effect on capital structure. Partially NPM has a negative and significant effect on capital structure. CR partially have a negative and not significant effect on capital structure. Partially Firm Size have a positive and significant effect on capital structure. Variables that have a significant effect on capital structure are NPM and Firm Size. While CR does not significantly affect the capital structure. Keywords: Capital Structure, Profitability, Liquidity, Firm Size


2021 ◽  
pp. 127891
Author(s):  
Miguel A. Peinado-Guerrero ◽  
Jesus R. Villalobos ◽  
Patrick E. Phelan ◽  
Nicolas A. Campbell

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