JAMES HARRIS ASSOCIATES INC.
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JAMES HARRIS ASSOCIATES INC.
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James Harris Associates provides a wide variety of services. Listed below are a selection of our offerings which are most frequently used. If you do not see your need expressed in this listing, please contact us. There is a very good chance that we can be of assistance. If we cannot help, we can probably refer you to a group that can provide what you need.
Good Manufacturing Practice regulations (GMPs) often seem to be a mysterious, ever-changing set of instructions written in some unknown language. Perhaps this is because virtually every major industrialized nation has written and rewritten their own pharmaceutical GMP regulations and continue to modify them on an ad hoc basis.
In the United States, the Food and Drug Administration (FDA) change their interpretation of GMPs as situations evolve. The changes made in these interpretations are not published in any single update, nor collected in any publication available to the general public. Therefore, it takes constant monitoring and a deep understanding of how FDA operates to understand and anticipate GMP requirements. Our consultants are devoted to training your organization to understand individual GMP regulations, performing GMP audits to determine the level of compliance, and helping a client comply with current GMP requirements.
Frequently, clients tell us that they know they need help, but can not give us a clear definition of that need. In this situation, it is often the best approach to start our relationship with a study which defines the current situation and outlines the overall objective. With this information at hand, we can then identify a method or pathway to take the client from their current situation to the one they want and need. This approach works equally well with strategic issues, organizational problems, process difficulties, scale-up, or facility design.
At some point in their life cycle, every pharmaceutical manufacturer needs a specialized process technology that they do not have within their current organization. The process may be so unique that the technology, as needed, may not exist within the industry, This uncharted territory is actually familiar ground to the process specialists from James Harris Associates. Our process specialists have many years of experience in the industry and have worked with a wide variety of unique situations in their consulting careers. This places them in a somewhat unique position of having direct experience in solving virtually any pharmaceutical processing problem. Their wealth of knowledge and understanding can give clients an effective, insightful solution in the shortest time possible. Clients receive the benefits of experience without incurring the cost of recruiting, training, or employee overhead.
Design and Engineering Specifications
Our consultants are experienced in new facility projects involving design, construction installation of process equipment, and facility start-up. We are not a construction engineering company and do not perform facility design work. We do work with the initial, conceptual design where the design concepts, general layout, and architectural finish specifications are determined. Of course, we also work extensively with the process design and equipment specification and procurement.
James Harris Associates has established full validation services, including training and validation consulting. We can take full responsibility for writing protocols and reports and performing or supervising all validation testing for any project.
Location Services
The old real estate cliche about the three most important considerations being location, location, and location is even more relevant when looking for a place to build a multi-million dollar manufacturing facility. The cost of the property, proximity to key suppliers, construction costs, accessibility, transportation, utilities and services, quality of life for employees, ability to attract key employees to the area, available work force, time required to obtain construction and occupancy permits, local taxes and incentives are but a few of the factors which must be considered. James Harris Associates has developed a methodology for assisting clients in understanding the alternatives and devising exactly what they hope to achieve with their new site. Wen then use this information to screen and evaluate potential locations. This process removes the emotional quotient from location decisions and helps focus the client on the factors which he has told us are most important to him. When desired, we keep our clients' identity confidential. This shields clients from developers and others who wish to influence the site selection decision. In many instances, we obtain options on land using a different corporate name in order to protect our client's identity.
Documentation
Many, many documents are required by today's modern manufacturer. JHA can not create the information that describes how you perform a specific task, but one of our technical writers can find out what you do and put it into words for you. Letting James Harris Associates take the drudgery out of writing reports and procedures frees your staff to concentrate on their regular jobs.
Project Management
Let James Harris Associates' professional managers run your projects. This not only allows your regular staff to continue with their normal workload, but normally results in more timely completion at a lower overall cost.
Quality
James Harris Associates can not only supplement your quality programs, they assist with program evaluations, implement new quality programs, provide training and help assure that your products maintain the quality level you desire.
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