AMPAC Fine Chemicals (AFC) is a technology-focused custom manufacturer of active pharmaceutical ingredients  (APIs) and registered intermediates.  They have capabilities in process development, scale-up and cGMP-compliant production from kilograms to multi-ton quantities. 

Their California based facilities specialize in the following state-of-the-art technology platforms:

• Commercial-scale production utilizing hazardous/energetic chemistries
• High-containment facilities for the production of high-potency APIs (HPAIPs) and intermediates
• Chromatographic separations using simulated moving bed (SMB) technology
• Continuous processing
• Specialized chemical capabilities

In order to support business growth and manage costs, AFC was in need of a supply chain management solution supporting commercial supplies as well as clinical trial supplies (CTS). The entire solution also needed to meet the compliance guidelines governed by the US FDA and other foreign agencies e.g. ICH Q7 for APIs

After a competitive selection process, AFC chose Oracle Process Manufacturing (OPM) as their preferred ERP solution, implemented by Business & Decision.

The choice was driven by the functionality provided by Oracle's Process Manufacturing solution and because of Business & Decision's long track record of cost effective implementation in the Life Sciences industry. AFC was impressed by Business & Decision's reputation for meeting aggressive time-lines and leveraging limited client resources through on-site consulting.

Business & Decision provided a complete line of services to support AFC's objectives, which included a full implementation of OPM including Financials, Purchasing, Order Management and the use of Electronic Records and Electronic Signatures (ERES).  Business & Decision also provided Compliance and Computer System Validation.

The overall goal of the Oracle implementation project was to facilitate a process of Supply Chain data integration required to help run the business and at the same time assist in increasing the speed at which data is made available. This allows AFC to make the right decisions faster and to provide improved Lot Traceability

A key advantage of the solution is the use of integrated, accurate and consistent data across all departments and the establishment an inventory structure to provide controls and visibility of AFC and Supplier inventory.

The Compliance and Computer System Validation services also provided AFC with a regulatory compliant business solution. The overall solution includes a significant amount of documentation to support the validation efforts; these documents include test scripts, protocols, traceability matrix, configuration manuals, validation plan and report, governance documentation, risk assessments, and training materials.

Business & Decision also host AFC's system in their qualified data center, managed and supported in accordance with regulatoty expectations for the control and compliance of operational systems.

As a result of the project AFC has acheived:

• Significant process improvements resulting in better accuracy, quality, and timeliness.
• A single system that allows them better visibility the Commercial Supply Chain.
• A compliant ERP system that provides AFC with full Lot Traceability capabilities.
• Additional controls over the release and movement of materials throughout the supply chain.

Ampac Fine Chemicals are running Oracle E-Business Suite with the following business processes / modules:

• Oracle Process Manufacturing (OPM) Inventory,
• Product Development,
• Production Execution,
• OPM Financials,
• Quality Management,
• Order Management,
• Procurement,
• Electronic Records and Electronic Signatures (ERES),
• Inventory,
• Financials and Process Planning.