The other GMP: good manufacturing practice and its importance in the validation of constructed pharmaceutical facilities

The work reported is part of an ongoing PhD study prompted by the particular difficulties encountered when two very different quality cultures interact (in this case Pharmaceutical industry clients and Construction industry providers). Pharmaceutical facilities have particular needs for their production requirements. Stringent regulations are set by regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) (in the UK) and the Food and Drugs Administration (FDA) in the US. This creates special problems of quality when it comes to the commissioning, validation and hand-over of the building, as it appears to be at odds with the rather less demanding quality systems that are normally accepted in the construction sector. The aim of the research is to model an acceptable process for incorporating these stringent validation requirements into the design, procurement and construction processes. There is little or no specific academic literature on the subject, though the trades and professional press (particularly in the USA) provide some normative comment on the problem area. The main academic grounding of the research is in Systems Theory and empirical data is being collecting using a multiple case study approach. Research data was collected from a number of pharmaceutical facility construction case studies and was used to test and inform a best practice model of facility validation. The qualitative methods of participant and direct observation were used as the main information gathering tools. The paper reports on the regulatory expectations that influence the construction of projects of this type and the impact on the best practice model of validation

The Workforce Needs of New Jersey's Pharmaceutical and Medical Technology Industry

This report is based on an online survey conducted in spring 2006 of pharmaceutical and medical technology companies in New Jersey. It identifies the current and future workforce needs of the pharmaceutical and medical technology industry in New Jersey

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers

As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in pharmaceutical industries all over the world and are now developing capabilities in biosimilar production. This emergence of a new market dynamic is disruptive to current key players as it has potential challenge their current dominant hold over the market, while for firms from developing countries it creates a sea of opportunities. This rise of biosimilars and capabilities for cheap production in developing country firms has potential to transform patient care in developing countries as well as advanced countries. This paper reviews study data collected at Innogen and the most recent literature to understand how the sector for biosimilars is evolving and the opportunities and challenges faced by emerging suppliers. The aim of the paper is to identify the gaps in the current literature and opportunities for further study in this area

The drug logistics process: an innovation experience

Purpose - The purpose of this paper is to present the latest innovations in the drug distribution processes of hospital companies, which are currently dealing with high inventory and storage costs and fragmented organizational responsibilities. Design/methodology/approach - The literature review and the in-depth analysis of a case study support the understanding of the unit dose drug distribution system and the subsequent definition of the practical implications for hospital companies. Findings - Starting from the insights offered by the case study, the analysis shows that the unit dose system allows hospitals to improve the patient care quality and reduce costs. Research limitations/implications - The limitations of the research are those related to the theoretical and exploratory nature of the study, but from a practical point of view, the work provides important indications to the management of healthcare companies, which have to innovate their drug distribution systems. Originality/value - This paper analyzes a new and highly topical issue and provides several insights for the competitive development of a fundamental sector

Looking Ahead: Workforce Supply/Demand Analysis for New Jersey's Pharmaceutical and Medical Technology Industries

This analysis presents the results of a workforce supply and demand analysis of the pharmaceutical and medical technology industries in New Jersey

Deposition velocities of airborne microbe-carrying particles

The deposition velocity of airborne microbe-carrying particles (MCPs) falling towards surfaces was obtained experimentally in operating theatres and cleanrooms. The airborne concentrations of MCPs, and their deposition rate onto surfaces, are related by the deposition velocity, and measurements made by a microbial air sampler and settle plates allowed deposition velocities to be calculated. The deposition velocity of MCPs was found to vary with the airborne concentration, with higher deposition rates occurring at lower airborne concentrations. Knowledge of the deposition velocity allows the deposition on surfaces, such as product or settle plates, by a known airborne concentration of MCPs to be predicted, as well as the airborne concentration that should not be exceeded for a specified product contamination rate. The relationship of airborne concentration and settle plate counts of MCPs used in Annex 1 of the EU Guidelines to Good Manufacturing Practice to specify grades of pharmaceutical cleanrooms was reassessed, and improvements suggested

Inventory drivers in a pharmaceutical supply chain

In recent years, inventory reduction has been a key objective of pharmaceutical companies, especially within cost optimization initiatives. Pharmaceutical supply chains are characterized by volatile and unpredictable demands –especially in emergent markets-, high service levels, and complex, perishable finished-good portfolios, which makes keeping reasonable amounts of stock a true challenge. However, a one-way strategy towards zero-inventory is in reality inapplicable, due to the strategic nature and importance of the products being commercialised. Therefore, pharmaceutical supply chains are in need of new inventory strategies in order to remain competitive. Finished-goods inventory management in the pharmaceutical industry is closely related to the manufacturing systems and supply chain configurations that companies adopt. The factors considered in inventory management policies, however, do not always cover the full supply chain spectrum in which companies operate. This paper works under the pre-assumption that, in fact, there is a complex relationship between the inventory configurations that companies adopt and the factors behind them. The intention of this paper is to understand the factors driving high finished-goods inventory levels in pharmaceutical supply chains and assist supply chain managers in determining which of them can be influenced in order to reduce inventories to an optimal degree. Reasons for reducing inventory levels are found in high inventory holding and scrap related costs; in addition to lost sales for not being able to serve the customers with the adequate shelf life requirements. The thesis conducts a single case study research in a multi-national pharmaceutical company, which is used to examine typical inventory configurations and the factors affecting these configurations. This paper presents a framework that can assist supply chain managers in determining the most important inventory drivers in pharmaceutical supply chains. The findings in this study suggest that while external and downstream supply chain factors are recognized as being critical to pursue inventory optimization initiatives, pharmaceutical companies are oriented towards optimizing production processes and meeting regulatory requirements while still complying with high service levels, being internal factors the ones prevailing when making inventory management decisions. Furthermore, this paper investigates, through predictive modelling techniques, how various intrinsic and extrinsic factors influence the inventory configurations of the case study company. The study shows that inventory configurations are relatively unstable over time, especially in configurations that present high safety stock levels; and that production features and product characteristics are important explanatory factors behind high inventory levels. Regulatory requirements also play an important role in explaining the high strategic inventory levels that pharmaceutical companies hold

Opportunities for greater Lincolnshire's supply chains: full report

A study of the key sector supply chains across Greater Lincolnshire, and identification of barriers and opportuniteis for growth

Technologie en innovatie in Vlaanderen: Prioriteiten.

Vlaanderen;

The implications of WTO accession on the pharmaceutical industry in China

Given the limited capabilities of R&D and global distribution channels, and the virtual non-existence of patented drugs, the Chinese pharmaceutical industry has little chance to enter the global market of Western prescription drugs and compete with the established global giants head-on. The reality is that they are chasing a moving target and their competitors are becoming bigger and stronger day by day. The substantial reduction of import tariffs and the granting of comprehensive trading and distribution rights to foreign-financed firms following WTO accession, effectively tilted the level-playing field against the Chinese pharmaceutical industry. Given the short-term competitive advantages of the Chinese pharmaceutical industry on Chinese drugs, three development strategies are suggested: (1) consolidate the local market of herbal and generic drugs; (2) market Chinese drugs via the Internet; and (3) outsource R&D and collaborative marketing