Pharmaceutical industry customers

A key aspect to a supplier s QMS for standard software products is its application to new product release. Without appropriate qualification of new developments, the quality attributes of the original system may be lost. Pharmaceutical industry customers are looking for consistent, if not improving, quality compliance, and this is especially so with product upgrades. 

The context of this work, at least superficially, is quality control in the chemical and pharmaceutical industries. The general principles apply to any form of (chemical) analysis, however, whether in an industrial setting or not. Other readers need only to replace some phrases, such as Health Authority with discriminating customer or official requirements with market expectations, to bridge the gap. The specifically chemical or pharmaceutical nomenclature is either explained or then sufficiently circumscribed so that the essentials can be understood by students of other disciplines. 

QA requires the efficient analysis of many samples to support routine production release and stability programs. Methods are typically established in the analytical development group. Efficiency and convenience issues, including the speed of media preparation and the relative convenience of data handling and documentation, are important here. While compliance is important in all aspects of the pharmaceutical industry, QA functions must approach compliance perfection. Depending upon the facility, the automated apparatus may be tailored to specific methods with fixed configurations. Dissolution methods may be routine enough that a custom system, optimized for productivity, may be justified. Compliance of USP and use of industry standard apparatus is important to maintain compatibility with other company laboratories or in the case contract laboratory services are required. 

For HCS to be fully accepted by academia, several conditions will need to be fulfilled. Current HCS instruments are closed black boxes and their expensive maintenance contracts do not allow any hardware or software modifications for adaptation to the diverse needs of academic research. Academic research is typically more diversified than pharmaceutical industry research and the instruments need to be more customizable than they are now. In addition, the image and data formats need to be accessible and open. In academia data is shared between collaborators and will be analyzed with various, partly custom-made software. Therefore the data needs to be accessible and open. Lastly, the yearly costs of maintenance contracts and licenses are particularly difficult to finance in academic research that relies heavily on grants. Grants typically do not cover licensing costs or if they do, when the grant runs out, new sources of funding must be found. In reality, those costs must generally be covered by institutional funds. 

Encouragement of the pharmaceutical industry to take a more active, direct, long-term responsibility for the safety of their products and customers, through reallocation of priorities and funds, as part of corporate social responsibility. 

Within the chemical universe, the fine-chemical industry is positioned between the commodity and specialty chemical industries. They are their suppliers and customers, respectively. Among the latter, the life sciences, especially the pharmaceutical industry, prevail (see Section 9.2). A large variety of enterprises, laboratories, and institutes in both the private and public sectors are providing contract research and manufacturing services along the drug supply chain (see Figure 2.1). 

For quantitative data, see Table 8.1. In the market, considerable risk exists because of the structure of the customer base, primarily the pharmaceutical industry ... 

Whereas for the pharmaceutical industry the patient, respectively the daily medical cost, is the driving force for establishing the target price for an API, it is the manufacturing cost for the fine-chemical/custom manufacturing company. 

Same customer category life science, especially pharmaceutical industry. 

ABC Pharmaceutical Industries is located (provide postal address). ABC Pharmaceutical Industries manufactures sterile pharmaceutical dosage forms in strict compliance to the cGMP, United States FDA guidelines. ABC Pharmaceutical Industries is supplying its products to its customers around the world. 

The information in this chapter applies specifically to the first element sample preparation. The sample preparation steps are usually the most tedious and labor-intensive part of an analysis. By automating the sample preparation, a significant improvement in efficiency can be achieved. It is important to make sure that (1) suitable instrument qualification has been concluded successfully before initiation of automated sample preparation validation [2], (2) the operational reliability of the automated workstation is acceptable, (3) the analyte measurement procedure has been optimized (e.g., LC run conditions), and (4) appropriate training in use of the instrument has been provided to the operator(s). The equipment used to perform automated sample preparation can be purchased as off-the-shelf units that are precustomized, or it can be built by the laboratory in conjunction with a vendor (custom-designed system). Off-the-shelf workstations for fully automated dissolution testing, automated assay, and content uniformity testing are available from a variety of suppliers, such as Zymark (www.zymark.com) and Sotax (www.sotax.com). These workstations are very well represented in the pharmaceutical industry and are all based on the same functional requirements and basic principles. 

Oh, you re just a distributor. If I had a nickel for every time I heard that when a prospective customer approached our booth at a trade show, let us just say I wouldn t have to be working. Many assume that the role of distributor can be relegated to that of middleman, reseller, or intermediary one who lacks the expertise of those who actually manufacture products— Oh So you just buy products and resell them to someone else. These gross oversimplifications do little to explain the scale, complexity, and critical role that a distributor plays in the movement of goods and services from manufacturer to end user (the supply chain), particularly in the pharmaceutical industry. 

In the pharmaceutical industry, the level of user need varies tremendously. Some large global pharmaceutical manufacturers have very efficient research and development (R D), sourcing, and purchasing units, but this is by no means representative of the industry as a whole. The level of expertise and experience of customers... 

First, a pharmaceutical excipient distributor should be committed to providing a very high level of service to their pharmaceutical customers. The pharmaceutical industry is highly detail focused, and the requirements of service can often surpass what a large-volume manufacturer or less specialized chemical distributor is willing or able to provide. 

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