API Manufacturing & Management Practices

APIs and advanced intermediates manufacturing solutions

Active Pharmaceutical Ingredient Manufacturing

Active pharmaceutical ingredients (API) and intermediates manufactures are faced with the tasks of  managing risk, improving process reliability and improving manufacturing efficiency in order to realize  production as soon as possible, reduce costs and improve compliance. Whether you are a contract  manufacturer or manufacture for internal use, profitability depends on managing manufacturing costs,  improving cycle times, reducing working capital, shortening the release process, improving asset utilization  and reducing waste. This all needs to be done while maintaining and improving your regulatory compliance  position.  Honeywell products and services can improve control  of your manufacturing processes, manage your  assetsto improve uptime, improve regulatory  compliance while managing the cost of compliance,  provide material traceability, and provide an electronic  batch record documenting operations. Taj skilled  professionals provide project execution, validation and  calibration services that result in timely  project execution, minimized time to compliance and effective  maintenance of validated systems.  Taj understanding of the pharmaceutical and biotech industries comes from successfully  implementing projects with many major suppliers. From the Experion Process Knowledge System® (PKS) to  the POMSnet MES application, Taj solutions are built with features specifically designed to meet  rigidregulator requirements.

• Taj distributed system architecture allows seamless integration of multiple Experion systems with minimum effort. Share history, alarms, real-time data, messages and more with no data duplication minimizing validation requirements.

• Qualification and Version Control System (QVCS) eases system configuration management and management of change by providing a means to electronically maintain the lifecycle and change history of Experion control modules.

• 21 CFR Part 11 compliance features help to ensure compliance.

• Honeywell solutions are designed to be consistent with the ISA S88 batch standard.

• Controller-based batch unit operations optimize cycle times and take advantage of the robustness of Experion controllers.

• Taj portfolio of security tools includes cyber security options, biometric access points and video control units, all of which are integrated into the Experion system.

• All components, whether hardware or software, are designed to integrate with the whole system without unnecessary implementation and maintenance effort.

• The Honeywell system is easily modified to accommodate needed process changes. This flexibility reduces time to market for new products and makes process improvements easy to implement.

• The Honeywell solution provides a step change in the quantity of process data available to a user. This is stored and made available in compliance with 21 CFR Part 11.

• Taj Procedure Analyst and Uniformance® PHD process historian provide powerful reporting capabilities. Electronic batch reports can be produced which meet regulatory requirements
  
  In the regulated pharmaceutical environment, the integrity and reliability of your automation system is particularly important for maintaining a view of the process and recording data for reporting and quality assurance. The Honeywell solution is designed for high availability in terms of both process control and data acquisition. When required, it can be fully redundant from transmitter or valve to HMI. Extensive diagnostics ensure that any problems are quickly identified.