TARRYTOWN, N.Y. -- Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., (NYSE NYSE
See: New York Stock Exchange :HIT) today announced that it is entering the market for pharmaceutical validation services through the acquisition of Validation Masters, Inc. (VMI VMI Virginia Military Institute
VMI Vendor Managed Inventory
VMI Vertical Motion Index
VMI Valtakunnan Metsien Inventointi (Finnish: National Forest Inventory)
VMI Video Module Interface
..... Click the link for more information.,) a premier validation services company. Terms were not disclosed. The acquisition of the company is designed to augment and enhance Hitachi's capabilities to provide total services to its clients in the pharmaceutical industry. The acquisition also makes the Hitachi Group Hitachi Group (Hitachi Gurupu) is a group of companies that uses the Hitachi name, which includes Hitachi Ltd. Hitachi Heavy Industries, etc. See also
* Hitachi
..... Click the link for more information. the first company to have active operations in both the U.S. and Japanese pharmaceutical services markets, enabling Hitachi to provide truly global services.
VMI will be incorporated into Hitachi America's Pharmaceutical Services Group and be known as Hitachi Validation Services. Paul Damurjian, president and founder of VMI will head the new unit and continue to execute current and future validation projects with proven and streamlined efficiency. He reports to Vito Cappello, P. E. director of the Pharmaceutical Services Group of Hitachi America. The new unit will be based at Hitachi offices in Basking Ridge, N.J.
In making the announcement, Masahide Tanigaki, executive vice president of Hitachi America said, "The acquisition of VMI is indicative of the strong synergy which exists between Hitachi and VMI. The company's experience and capabilities, dedication to quality, flexibility and client service are the paramount elements of our customers' requirements. VMI brings these key elements to our Pharmaceutical Services Group. We intend to maintain the local focus and competitiveness while providing our clients with the potential of utilizing the broad technical, process, engineering and manufacturing, and financial strength of Hitachi."
The company said that the validation scope of services will include Validation Master Plan Development along with Equipment, Facility and Computer Systems Qualification. Additionally, Environmental Monitoring, Cleaning Validation The introduction to this article provides insufficient context for those unfamiliar with the subject matter.
Please help [ improve the introduction] to meet Wikipedia's layout standards. You can discuss the issue on the talk page.
..... Click the link for more information., Vendor Auditing and Validation Project Management services will be offered.
Hitachi Pharmaceutical is a global total solutions provider. Hitachi is dedicated to working in partnership with its global clients in order to bring future market product requirements to successful fulfillment by offering a total project solution with integrated, seamless services and products that include pilot plant and process simulation software Simulation software is based on the process of imitating a real phenomenon with a set of mathematical formulas. It is, essentially, a program that allows the user to observe an operation through simulation without actually running the program.
..... Click the link for more information., conceptual/basic/detailed engineering, worldwide procurement, construction, validation and final acceptance, project financing Project financing
A form of asset-based financing in which a firm finances a discrete set of assets on a stand-alone basis. , process and utility equipment supply and fabrication fabrication (fab´rikā´shn),
n the construction or making of a restoration. and modularization facilities.
Hitachi has had a major presence in the Asian pharmaceutical industry since 1948. Hitachi has provided "total project solutions" to more than 200 bulk and bio-pharmaceutical projects including grassroots, revamp and expansion of commercial and research facilities related to mammalian cell culture, microbial microbial
pertaining to or emanating from a microbe.
microbial digestion
the breakdown of organic material, especially feedstuffs, by microbial organisms. culture, chemical synthesis In chemistry, chemical synthesis is purposeful execution of chemical reactions in order to get a product, or several products. This happens by physical and chemical manipulations usually involving one or more reactions.
..... Click the link for more information., fill and finishing, pilot plants and R&D. For further information on Hitachi's validation services, customers and prospects can call 908.605.2770 or visit www.validationmasters.com.
Hitachi America, Ltd., a subsidiary of Hitachi, Ltd., markets and manufactures a broad range of electronics, computer systems and products, and consumer electronics, and provides industrial equipment and services throughout North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere.
..... Click the link for more information.. For more information, visit http://www.hitachi.us.
Hitachi, Ltd., (NYSE:HIT) (TOKYO:6501), headquartered in Tokyo, Japan, is a leading global electronics company with approximately 347,000 employees worldwide. Fiscal 2004 (ended March 31, 2005) consolidated sales totaled 9,027.0 billion yen ($84.4 billion). The company offers a wide range of systems, products and services in market sectors including information systems, electronic devices, power and industrial systems, consumer products, materials and financial services The examples and perspective in this article or section may not represent a worldwide view of the subject.
Please [ improve this article] or discuss the issue on the talk page. . For more information on Hitachi, please visit the company's website at http://www.hitachi.com.
Wednesday, November 25, 2009
Redefining Pharmaceutical Process Validation
FDA's new process validation guidance spells out the new rules for process validation. In this webcast, industry experts discuss the guidance, what it means to manufacturers, how to apply a Six Sigma approach to validation and how to apply new principles to improve a legacy product.
For Jim Agalloco's presentation, "FDA’s Guidance for Industry Process Validation: Impact Assessment", click here.
For Bikash Chatterjee's presentation, "Building and Tailoring a Lean Six Sigma Approach for Validation Processes", click here.
For FDA/CDER's Joseph C. Famulare's presentation, "Process Validation – Key Areas Leading to 483’s", click here.
For NNE Pharmaplan's Line Lundsberg-Nielsen's presentation, "The Impact of FDA’s Proposed Process Validation Guidance on Quality by Design for Legacy Products", click here.
For additional information on our upcoming webcast series, click here.
Pharmaceutical Process Validation: An International Edition
Book Description
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Book Info
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Book Info
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more.
Validation Standard Operating Procedures
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
Book Description
Ideal for pharmaceutical, medical device, and biotechnology industries, Validation Standard Operating Procedures guides design engineers, manufacturing personnel, researchers, and quality control professionals in validating processes needed for non-aseptic and aseptic pharmaceutical production. This second edition provides 131 ready-to-use master validation procedures, template protocols, and reports. With 14 exclusive environmental performance evaluations, it features 57 new protocols on such topics as sterility assurance, media fill guidelines, and environmental control. It also includes a CD-ROM with a template of customizable validation standard operating procedures.
Book Info
(St. Lucie Press) Outline provides information managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines. Includes directions for translating GMP requirements into action and describes how to establish test functions and prevent defects. CD contains 74 template procedures.
Book Description
Ideal for pharmaceutical, medical device, and biotechnology industries, Validation Standard Operating Procedures guides design engineers, manufacturing personnel, researchers, and quality control professionals in validating processes needed for non-aseptic and aseptic pharmaceutical production. This second edition provides 131 ready-to-use master validation procedures, template protocols, and reports. With 14 exclusive environmental performance evaluations, it features 57 new protocols on such topics as sterility assurance, media fill guidelines, and environmental control. It also includes a CD-ROM with a template of customizable validation standard operating procedures.
Book Info
(St. Lucie Press) Outline provides information managers need to establish functions, acceptance criteria, and validation procedures in compliance with FDA guidelines. Includes directions for translating GMP requirements into action and describes how to establish test functions and prevent defects. CD contains 74 template procedures.
Pharmaceutical Master Validation Plan
Book Description
This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.
Book Info
(St. Lucie Press) Provides a generic format for a Master Validation Plan using a pharmaceutical manufacturing site with sterile and non-sterile operations as the case facility. Provides a road map for validation to establish FDA requirements/procedures, validation programs, protocols, and resource planning and scheduling. DNLM: Drug Industry--standards.
This book provides the tools to more easily achieve satisfactory inspections, new medical product approval, minimize non-conformance, reduce rework and rejected lots, and avoid recall lots by developing and managing a Master Validation Plan. The accompanying CD provides a template that can be customized to incorporate additional regulatory requirements specific to individual companies worldwide. Together, the book and CD contain everything required to develop and execute a successful Master Validation Plan based on FDA guidelines for the pharmaceutical industry, and allows the templates to be extended to diagnostic products, medical device, medical equipment, and biotech industry products.
Book Info
(St. Lucie Press) Provides a generic format for a Master Validation Plan using a pharmaceutical manufacturing site with sterile and non-sterile operations as the case facility. Provides a road map for validation to establish FDA requirements/procedures, validation programs, protocols, and resource planning and scheduling. DNLM: Drug Industry--standards.
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