Green Chemistry and Sustainability Metrics in the Pharmaceutical Manufacturing Sector

Manufacturers of dietary supplements meet growing regulatory demands for control of the production process, with the main goal of launching a quality based product, by which they ensure user’s protection and contentment. Demand for cleaning validation represents a multidisciplinary activity that brings together experts from around the world with a common goal: to ensure the efficacy of the cleaning operation in pharmaceutical manufacturing. Main goal of this work is to describe cleaning validation process in the manufacturing sector of liquid pharmaceutical forms- that consists of syrup and spray manufacturing. Pursuant to all guidelines of the European and National regulations, cleaning validation was initiated by designing Validation plan and Risk assessment plan for the manufacturing line of liquid pharmaceutical forms. Specified processes of cleaning were used, while specific physical, chemical and microbiological parameters were followed, and the process was complimented by a Validation protocol that documented three consecutive washing c ycles; directed at three consecutive batches of the same products on that manufacturing line for sprays. Final report of the validation process is being coordinated, followed and improved by the Quality sector. This enabled validation and efficacy of the chosen cleaning processes, but certain parameters were still being followed and analysed in order to prove conformity and/or allow changes that might arise. A goal of the pharmaceutical company to produce quality and safe products is achieved by applying principles of cleaning validation, and by using and mproving established cleaning procedures.

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The relative importance of quality costs in Jordanian pharmaceutical manufacturing sector and their deficiencies

Journal of administrative and business studies ◽

10.20474/jabs-3.1.2 ◽

2017 ◽

Vol 3 (1) ◽

Keyword(s):

Manufacturing Sector ◽

Pharmaceutical Manufacturing ◽

Relative Importance ◽

Quality Costs

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A Quantitative Analysis of the Causes of Drug Shortages in Jordan: A Supply Chain Perspective

International Business Research ◽

10.5539/ibr.v9n6p53 ◽

2016 ◽

Vol 9 (6) ◽

pp. 53 ◽

Cited By ~ 10

Author(s):

Hala Awad ◽

Zu'bi M.F. Al-Zu'bi ◽

Ayman Bahjat Abdallah

Keyword(s):

Supply Chain ◽

Human Factors ◽

Manufacturing Sector ◽

Supply And Demand ◽

Decision Makers ◽

Pharmaceutical Manufacturing ◽

Drug Shortage ◽

Drug Shortages ◽

Study Results ◽

Legislative Processes

<p>This study investigates the causes of drug shortage in Jordan. Based on thorough literature review, five causes related to supply chain were identified, namely regulatory and legislative processes, manufacturing-related issues, distribution factors, supply and demand imbalance, and human factors.</p><p>Data were collected from 221 professionals selected from Jordan Food and Drug Administration (JFDA), pharmaceutical manufacturing sector, hospital professionals, and other nodes in the supply chain including distributors and wholesalers. Multiple-regression analysis was used to test the hypothesized relationships. The results indicate that four causes are significantly related to drug shortages in Jordan, regulatory and legislative processes, distribution factors, human factors, and supply and demand imbalance. Manufacturing-related issues are not significantly related to drug shortages. Implications and recommendations for the decision makers are proposed on the basis of the study results.</p>

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