Chapter 26 Pharmaceutical Manufacturing

2016 ◽  
pp. 359-374
Keyword(s):  
Pharmaceutical Manufacturing

Technology Transfer in Pharmaceutical Manufacturing - A Review

2018 ◽  
Vol 9 (3) ◽  
Author(s):  
Amit B Patil ◽  
Bharath Kumar B ◽  
Ajay P Karnalli
Keyword(s):  
Technology Transfer ◽  
Drug Development ◽  
Research And Development ◽  
Product Quality ◽  
Pharmaceutical Product ◽  
Pharmaceutical Manufacturing ◽  
Shop Floor ◽  
R And D ◽  
Production Shop ◽  
Execution Procedures

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.

FAKTOR DETERMINAN PEMBENTUK STRUKTUR MODAL PADA PERUSAHAAN SEKTOR FARMASI PERIODE 2012 - 2016

2017 ◽  
Vol 2 ◽  
pp. 241-250
Author(s):  
Neng Ria Kanita ◽  
Hendryadi Hendryadi
Keyword(s):  
Panel Data ◽  
Capital Structure ◽  
Firm Size ◽  
Stock Exchange ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Companies ◽  
Purposive Sampling ◽  
Panel Data Regression ◽  
Data Regression ◽  
Partial Effects

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

Modeling and Control of Roller Compaction for Pharmaceutical Manufacturing

2010 ◽  
Vol 5 (1-2) ◽  
pp. 24-36 ◽  
Author(s):  
Shuo-Huan Hsu ◽  
Gintaras V. Reklaitis ◽  
Venkat Venkatasubramania
Keyword(s):  
Pharmaceutical Manufacturing ◽  
Roller Compaction ◽  
Modeling And Control ◽  
And Control

A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer
Keyword(s):  
Control Strategy ◽  
Control Strategies ◽  
Pharmaceutical Manufacturing ◽  
Production Facility ◽  
Vaccine Production ◽  
Contamination Control

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

Benchmarking of TQM practices in the Jordanian pharmaceutical industry (a comparative study)

2018 ◽  
Vol 25 (9) ◽  
pp. 4058-4083 ◽  
Author(s):  
Maysoon Mohammed Yaseen ◽  
Rateb J. Sweis ◽  
Ayman Bahjat Abdallah ◽  
Bader Yousef Obeidat ◽  
Nadia J. Sweis
Keyword(s):  
Quality Management ◽  
Comparative Studies ◽  
Pharmaceutical Manufacturing ◽  
Current Status ◽  
Pharmaceutical Companies ◽  
Manufacturing Companies ◽  
Total Quality ◽  
Critical Factors ◽  
Content Type ◽  
Manufacturing Company

Purpose The purpose of this paper is to establish practical guidelines for benchmarking eight total quality management (TQM) practices vital to pharmaceutical companies’ performance. The paper also proposes the use of an analytic total quality index (TQI) as a benchmarking tool and illustrates the importance and effectiveness of this benchmarking methodology by applying it in two comparative studies of three Jordanian pharmaceutical companies. Design/methodology/approach In order to achieve the above-mentioned purpose, the data were gathered through a questionnaire that was used to evaluate the gap between the ideal and current status of the quality management system and distributed to the quality units from three companies: pharmaceutical manufacturing company, a pharmaceutical manufacturing company working in the same field and a pharmaceutical service providing research services to a pharmaceutical manufacturing companies. And the mean differences between the current and ideal states for the eight critical TQM practices were compared for these two comparative studies using the t-test. Findings Each of the two comparisons reveals statistically significant differences regarding the perceptions of actual and ideal scores for manufacturing and service companies on five out of eight critical factors and, on two out of eight critical factors for manufacturing and manufacturing companies. Practical implications The pharmaceutical companies, regardless of whether they are manufacturing or service company, can adopt benchmarking techniques which were applied in this case study to improve their performance and their product/service quality. Originality/value The consequences of this research can support organization managers and policy makers in effectively benchmarking the identified TQM practices in their organizations using the proposed TQI benchmarking tool.

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