“Life is Time, and Time is Gold” (Part 2): OPEX in Pharmaceutical Manufacturing

Operational Excellence (OPEX) has at its core: Organization, Communication, Visibility, People, Process, and Equipment. It touches on all aspects of an organization, requiring strong commitment from higher management and business leaders. OPEX in a company has many subsystems: each subsystem is critical, with each element reinforcing the other.

Toyota, with its pioneering work on organizing production to obtain brilliance, employed technical toolkits such as Just In Time (JIT), Total Productive Maintenance (TPM), and Total Quality Management (TQM). Toyota found that success needed something deeper than a technical toolkit. TPS (Toyota Production System) embraces the social and cultural management of quality and work organization. Support, encourage, continually improve processes and people is its focus.

OPEX, therefore, is not a one-size-fits-all shopping trip. Sometimes the mission and focus of the manufacturing facility has to be on management practices rather than technical procedures.

In pharmaceutical manufacturing you can’t go very far without addressing regulation. Regulations do provide constraint, but there is more than enough room for life science manufacturing to improve on all four key business processes. Remember OPEX is about organization, visibility and communication. Ergonomics swings data around; focusing knowledge on specific driven needs.

zenon Analyzer is a gift to production agility, supplying much more than vision alone. From production, a single version of the truth is presented individually to different focus groups. Engineering needs information on plant running conditions, early indicators of equipment wear out, root cause analysis.

RBE Alarms and TrendsQuality needs real-time CQA (Critical Quality Attributes) to be communicated before violations are compromised, process variation analyzed, for fast and accurate automated batch analysis, and succinct post-production analysis, as for example, with Report By Exception (RBE) reports.

Operations need availability, batch reports, information focused on daily improvement. Dime and Dollar figures are the underlining motivation for higher Management to show processes on these terms. People need the confirmation that their actions are beneficial; live accurate information keeps a strong heartbeat running through the organization.

New Process Development and New Product Development have a hard time in regulated environments without Batch Control. Flexibility and agility require an ability to perform process changes quickly. Batch Control manages these processes and equipment structures through recipes, thus allowing for easy process flow modifications and equipment usage. A batch recipe cannot violate predefined equipment performance, therefore each recipe is deterministic, and with no change to the compliant production equipment new process flows can be validated efficiently.

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