Ampac Fine Chemicals automates regulatory compliance with Oracle(R) applications

June 20, 2007 — /PRNewswire-FirstCall/ — REDWOOD SHORES, CA — Oracle today announced that Sacramento, CA.-based Ampac Fine Chemicals (AFC), a wholly owned subsidiary of American Pacific Corporation that manufactures active pharmaceutical ingredients and registered intermediates, has deployed Oracle(R) E-Business Suite financial, procurement, and manufacturing capabilities to help facilitate regulatory compliance, improve operational efficiency, and ensure scalability to support company growth. AFC selected Business & Decision, a Certified Advantage Partner in the Oracle PartnerNetwork, to implement and host the solution.

As a supplier to the pharmaceutical industry, AFC must operate in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP). The company is automating many aspects of its quality system with Oracle Process Manufacturing, which allows it to standardize and control its end-to-end manufacturing processes. As important, AFC uses Oracle Process Manufacturing and Oracle E-Records to help ensure an audit trail of materials, as well as manufacturing and distribution processes, by providing a framework for securely capturing, storing, and printing 21 CFR Part 11-compliant electronic records and signatures.

“Oracle E Business Suite is a critical element of our strategy to maintain operational excellence in all aspects of our business,” states Dr. Aslam Malik, president of AFC.

“We looked at several enterprise application vendors, including SAP and Ross,” says Paul Kane, AFC’s chief financial officer. “Only Oracle offered a solution that could meet our unique needs as a process manufacturer in the life sciences industry. In fact, Oracle Process Manufacturing is so well suited to our industry and business that we completed implementation and validation of our new system in just six months — enabling faster return on our technology investment.”

Beyond automating its quality system, AFC is using Oracle Process Manufacturing to drive greater operational efficiency and productivity in its manufacturing operations. With Oracle, the company is automating core manufacturing management processes and building a single source of information that enables visibility across the entire manufacturing lifecycle — from scheduling and work-in-progress through distribution, release to customer and invoice payment. The Oracle Applications have also been integrated with the company’s materials requirements planning (MRP) process to improve scheduling and help ensure that the correct raw materials are at the appropriate manufacturing facility when needed — enabling the company to reduce the risk and expense involved with storing excess inventory of raw materials.

AFC selected Business & Decision, an international consulting company, to guide it through its implementation and host its Oracle E-Business Suite solution. Business & Decision was involved with the initiative at every stage of the process — from identifying the best solution for AFC’s needs to completing documentation and managing the training process.

Mapping and analyzing key business processes were important components of Business & Decision’s work with AFC as the company wanted to minimize customization to reduce implementation costs and accelerate deployment. The process design component, therefore, was critical because the company had committed to adapting its business processes to fit the best-practices supported by the software.

“We are delighted to contribute to the success of the implementation of Oracle E-Business Suite for AFC. We are genuinely proud to have helped select, design, deploy and now host these critical applications for a regulated environment,” said Robin Kearon, chief executive officer of Business & Decision, North America.

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