Life Sciences, Compliant Packaging

Competition is relentless. Supply chain performance demands are escalating. Coordination with customers necessitates immediate responsiveness. Change is constant. As overall supply chain performance becomes more dependent upon production execution, the need to tightly link enterprise-level supply chain planning and management with plant-level execution environments is essential. Without tight business integration between the enterprise and it's manufacturing resources (plants and contract manufacturers), manufacturers risk being left behind.

The Situation
Pharmaceutical manufacturing and packaging are challenging operating environments that are under constant pressure to deal with all of the traditional requirements of any production environment (demanding production schedules, ongoing initiatives to increase yield and efficiency, balancing production time with maintenance requirements, etc.), while also satisfying a demanding set of FDA requirements. These factors combine to make Life Science manufacturing and packaging uniquely challenging, particularly when dealing with change. As such, the operating metrics for Life Science manufacturing and packaging lag well behind general industry. The overall state of manufacturing in this industry can be described with the following operating metrics:

• Excessive Scrap and Rework
  • Rework and Discarded Product: 50%
• High Work-In-Process (On-Hold) and Finished Goods inventory Levels:
  • On-Hold Product Inventories: 40 – 60 days
• Low Capacity Utilization
  • Plant Utilization: 50%
• Protracted and Unpredictable Cycle Times:
  • Manufacturing Cycle Time: 30 – 60 days
  • Batch Release: 60 days
  • Cycle Times Double for Batches with Non-Conformances
  • Non-Value Adding Activities Account for 90% of the Overall Manufacturing Cycle Time

What's Needed
Improving overall performance in pharmaceutical packaging environments requires a comprehensive solution that systematically enforces compliance, while also enabling operational excellence. This challenge can be expressed in terms of the following general requirements:

• Error-proofing to the maximum extent practical
  • Physical / mechanical elements and sensors to prohibit / detect incorrect actions by operating personnel
  • Systems technology applied to enforce compliance, eliminate / reduce opportunities for human mistakes, and control / monitor the process
    • Automation of operational activities (information exchange between enterprise / supervisory-levels and the control-level)
    • Integrity checking of all data which is manually-entered
    • Enforcement of the qualified operating sequence
• Near-real-time responsiveness
  • To proactively monitor and manage the packaging environment in a manner that keeps pace with the actual shop floor packaging processes (packaging equipment and control systems)
  • To address enterprise-level changes which impact packaging activities in a flexible and efficient manner
• Decision making based on current, complete, and accurate information
  • To assure decision making which aligns with enterprise-level plans (schedule adjustments, manufacturing procedure changes, etc.)
  • To drive efficiency (regarding set-ups, changeovers, etc.)
  • To enable manage exceptions and error-conditions

System Solution Concepts
Satisfying the general requirements for compliant packaging will require the engagement of systems technology in a manner that provides:

• Seamless connectivity from the enterprise to the shop floor (to minimize integration and data transformations)
• Direct, timely access to current data at both the enterprise and shop floor levels
• Usability which supports and enables efficient and comprehensive decision making for both Shop

The Opportunity
Given that many Life Science organizations already use SAP for their business and enterprise-level processes, and that much of the data needed to drive enforced compliance resides within SAP, it's appropriate to consider whether SAP can adequately service the requirements for compliant packaging. SAP's capabilities regarding the general requirements are as follows:

• Error proofing: Standard SAP technology can be used to deliver the necessary information and business rules at the shop floor level to comprehensively support error proofing through:
  • Direct connectivity and automated interaction with shop floor systems (via PI-PCS)
  • Enforced workflow (via SAP Process Instruction Sheets) to drive the qualified sequence of operations of the packaging environment (materials, personnel, equipment, procedures / recipe, etc.) prior to initiating the packaging line
  • Access to master data and the application of focused business logic necessary to verify the integrity of manually entered data
• Near real-time responsiveness: Standard SAP technology (such as SAP-ODA) can be engaged for integration with OPC-compliant shop floor systems to facility the automated acquisition of shop floor data
• Decision making: Within typical packaging environments, SAP can effectively support the timing and work flow associate with operational or quality decisions without introducing any delays in to packaging operations
• Seamless connectivity: Standard SAP technology can be extended to the shop floor to deliver execution-level functional through both automated interaction with shop floor systems as well manual interaction
• Direct access to current data: Extending SAP to provide execution-level functionality leverages the master data resident within SAP while also avoiding additional data exchanges / transformations necessary for SAP to interact with separate MES / EBR systems and also positions SAP to directly access time-sensitive process or production data
• Usability: Standard SAP technology in the form of Process Instruction (PI) sheets and cockpits can be engaged to dramatically enhance the usability of SAP in shop floor environments. Specifically, PI sheets can be used to present detailed workflow instructions and related information to shop floor users in a manner which is significantly more efficient and convenient to interact with than traditional SAP transactions.

Additionally, SAP offers many unique advantages as the systems technology to drive compliant packaging, including the following:

• One version of the truth – since all data is resident in SAP, no other systems beyond the control systems are required. Using SAP as the system of record, eliminates the need for multiple data sets and the associated transformations between systems
• Reduced cost of integration – by eliminating the need for additional systems (such as MES / EBR) between the Enterprise and the packaging control system-levels, the costs associated with integrating and sustaining multiple systems (are dramatically reduced)
• Reduced cost of ownership: Without the need to implement and maintain systems and data sets between SAP and the shop floor, ownership costs can be dramatically reduced through the reduction of licensing, training, support, and staffing.

The Solution
Using standard SAP technology to achieve compliant packaging has already been successfully implemented. Leading Life Science manufacturers are leveraging their SAP investments to connect their enterprise and shop floor environments – including packaging - using EnteGreat's Compliant Manufacturing Framework. EnteGreat's Compliant Manufacturing Framework is a library of proven best practice accelerators for executing regulated manufacturing using SAP which includes:

• An extensive library of pre-configured SAP components including
  • PP-PI master recipes
  • Standard business processes
  • User interface enhancements
• Business processes (cGMP signature strategies, etc.)
• Proven templates for defining manufacturing objects and activities in a cGMP environment using industry standards (ISA-88 and ISA-95)
• Proven templates and examples for configuring and implementing cGMP manufacturing applications
• Proven content for US FDA / GAMP Computer Systems Validation documentation
• Proven content for training and systems documentation
• A robust baseline system for rapid prototyping
• SAP Powered By NetWeaver Certification

Proven Benefits
Establishing a compliant packaging environment using standard SAP technology yields substantial business benefits, which include the following:

• An "integral" solution which extends the same supply chain planning and management platform (SAP) directly to the supply chain execution-level (packaging line level)
• "Compliant First-Time"
  • By using current and accurate data during rigorous set-up and qualification procedures as well as during on-going monitoring of the packaging line during it's run cycle, the opportunity to produce non-compliant product is dramatically reduced – thus providing an environment which is designed to deliver compliant, saleable product from the first production unit of each batch
• Batch records in electronic form to:
  • Eliminate virtually all of the batch record errors associated with manual data entry
  • Enable exception-based QA batch record review
• Reduced packaging line staffing
  • Typically, fully-integrated packaging lines can be attended and managed with less Operating personnel and the need for line-level Quality personnel is eliminated
  • Many of the mundane, clerical activities previously performed by packaging team personnel (such as manually-performed calculations and hand-written batch record data entries) are automated, so that the packaging team personnel can focus on operating the line in an optimal manner and immediately addressing any line-level exceptions that arise
• Improved materials management
  • Since all materials are qualified before usage based on current and accurate information, waste and rework are reduced
• Reduced non-conformance events
  • By qualifying all aspects of the packaging line environment based on current and accurate data, many typical non-conformance events are dramatically reduced
• Improved responsiveness and flexibility to support product / SKU changes
  • By automating the information exchanges associated with changeovers (recipes, set-up parameters, SOPs, manufacturing production instructions, etc.), the time and effort associated with changeovers can be significantly reduced
• Improved asset utilization
  • Reducing the down-time between product / SKU changes and qualifying the packaging environment (equipment, materials, environment, procedures, and personnel)
• Access to current and accurate shop floor data to facilitate
  • Continuous improvement and process excellence initiatives
  • Accelerate excursions and investigations needed to resolve batch production / record anomalies
• Reduced total cost of ownership
  • By leveraging existing investments in SAP and extending that platform from the enterprise-level to the shop floor level offers considerable savings by avoiding the costs associated with the introduction of additional (non – SAP) systems for execution-level functionality as well as the implementation and sustainment of integration between SAP and third-part execution-level systems

Learn more about the solutions that EnteGreat's clients are using to achieve compliant packaging at the Pharmaceutical Packaging Forum on March 12, 2008 at the Rittenhouse Hotel-Philadelphia. EnteGreat's Mark Kovacs, along with Bob Streit and Moin Hussain, both of McNeil Consumer Healthcare (a unit of Johnson & Johnson), presented Achieving Compliant Packaging Through Shop Floor Integration at 3:30PM.