A Comparative Study of the Lateral Work Activities of Three Production Managers in the UK Manufacturing Industry and the Implications for Training Production Managers

This article examines how intensifying inequality in the UK plays out at a local level, in order to bring out the varied ways polarisation takes place ‘on the ground’. It brings a community analysis buttressed by quantitative framing to the study of economic, spatial and relational polarisation in four towns in the UK. We distinguish differing dynamics of ‘elite-based’ polarisation (in Oxford and Tunbridge Wells) and ‘poverty-based’ polarisation (in Margate and Oldham). Yet there are also common features. Across the towns, marginalised communities express a sense of local belonging. But tensions between social groups also remain strong and all towns are marked by a weak or ‘squeezed middle’. We argue that the weakness of intermediary institutions, including but not limited to the ‘missing middle’, and capable of bridging gaps between various social groups, provides a major insight into both the obstacles to, and potential solutions for, re-politicising inequality today.

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Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors

Generics and Biosimilars Initiative Journal ◽

10.5639/gabij.2020.0904.028 ◽

2020 ◽

Vol 9 (4) ◽

pp. 171-182

Author(s):

Sia Chong Hock ◽

Vernon Tay ◽

Vimal Sachdeva ◽

Chan Lai Wah

Keyword(s):

Manufacturing Industry ◽

Management Practices ◽

Data Integrity ◽

Database Management System ◽

World Health ◽

Record Management ◽

Guidance Documents ◽

Health Organization ◽

Biopharmaceutical Manufacturing ◽

The Uk

Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of the pharmaceutical industry in recent years. With the growing use of computerized systems and rising prevalence of outsourcing manufacturing processes, ensuring data integrity is becoming more challenging in an increasingly complex pharmaceutical manufacturing industry. To address this issue, multiple legislation and guidance documents such as ‘Data Integrity and Compliance with CGMP Guidance for Industry’ from the US Food and Drug Administration (FDA), ‘GxP’ Data Integrity Guidance and Definitions from the UK Medicines & Healthcare products Regulatory Agency (MHRA), and ‘Guidance on Good Data and Record Management Practices’ from the World Health Organization (WHO), have been published in recent years. However, with rising data integrity issues observed by FDA, WHO, MHRA and other pharmaceutical inspectors even after these guidance documents have been published, their overall effectiveness is yet to be determined. This paper compares and evaluates the legislation and guidance currently in existence; and discusses some of the potential challenges pharmaceutical manufacturers face in maintaining data integrity with such legislation and guidance in place. It appears that these legislation and guidance are insufficient in maintaining data integrity in the industry when used alone. Last, but not least, this paper also reviews other solutions, such as the need for a company culture of integrity, a good database management system, education and training, robust quality agreements between contract givers and acceptors, and performance of effective audits and inspections, to aid in maintaining data integrity in the manufacturing industry. These proposed solutions, if successfully implemented, can address the issues associated with data integrity, and raise the standard of pharmaceutical and biopharmaceutical manufacturing worldwide.

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