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Growing and mid-sized pharmaceutical companies have never been under greater pressure from external market forces than they are today. From payer-driven cost management and heavily-scrutinized government healthcare budgets to increased competition and an increasingly complex regulatory landscape, external factors are forcing companies to modify their business models.

Companies need to gain agility and efficiency across critical business operations, including formulation management, traceability, production management, and quality control. Ideally, a single IT system of interconnected data and processes will support these four operational areas; at the very least, multiple systems that are seamlessly integrated to optimize speed, effectiveness, and efficiency should support them.

Without operational connectedness, companies can’t compete and thrive – an issue highlighted in a recent report by PWC that says:

This is an industry that has long operated through disparate components — silos that separated R&D, commercial, production, and supply chain. These silos can obstruct patient access and breed inefficiency and waste. They affect drug approval time and pricing, influence support for specific drugs by the medical community, and seriously hinder financial performance.

What must IT systems do in each area, and how can they interconnect?

 

Formulation Management

Formulation is the core of any pharmaceutical, which is why the underlying information system must capture all formula-related data as it evolves. This includes every version of a formula and its different packaging specifications, side-by-side spec comparisons, automated workflow approvals, and historical notations regarding formulation procedures.

Because formulation drives product material purchases, the information system should track the raw materials on hand as well as the quantity needed to satisfy sales forecasts. Through proper automation capabilities, the system should enable workflows that automatically initiate orders of raw materials in line with sales forecasts and anticipated production needs.

From an interconnectedness standpoint, the system should allow developers to incorporate QC test data and manufacturing personnel to attach specific manufacturing instructions to formula information. For traceability, the system should make changes easier by tracking raw inputs back to individual suppliers.

 

Traceability

Regulators around the world require track and trace of pharmaceuticals, from manufacture to administration. As such, the underlying information system must associate a wealth of data with every product batch, including:

  • Manufacturer identity
  • Manufacturer address
  • Name or designation of active pharmaceutical ingredient
  • Manufacturer's batch number
  • Customers receiving batch numbers
  • Transportation and distribution records
  • Certificates of analysis
  • Expiration date(s)

From a ‘one-up, one-down’ perspective, the system should also provide similar data about the raw materials received from suppliers.

From an interconnectedness standpoint, the traceability data should be automatically associated with product batch data, which would make tracing product more meaningful, as each traced batch could yield its QC data and raw material supply data. This makes isolating problems easier in the event of a product recall or defect, leading to faster resolutions.

 

Production Management

To manage production accurately and efficiently, the information system behind production management must gather valuable data inputs from across the organization – it’s the only way to make the connection between what a company sells and what it produces. Therefore, the system must integrate data from sales, demand forecasts, supplier restrictions, supplier incentives, lead-time forecasts, machine/production line availability and utilization, etc. Therefore, the system needs simple, flexible processes and workflow modeling.

Production management represents the ultimate need for interconnectedness among IT systems across key operational areas.

 

Quality Control

To perform quality control correctly, Pharma manufacturers need an underlying information system that unifies batch-related data, which includes results from sample testing, expiry dates, traceability data, and manufacturing QC data. As such, the IT system should allow for modeling of processes and automate them so QC data becomes tied to every batch produced. This begins with pulling data about raw material and raw material suppliers, moving through production, and ending with consumer-reported outcomes data.

How interconnected should QC information systems be with other critical operational areas? According to the FDA:

Quality should be the responsibility of all persons involved in manufacturing. Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. The system for managing quality should encompass the organizational structure, procedures, processes and resources, as well as activities to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented.

 

Conclusion

It’s time for pharmaceutical companies to make their operations more efficient by seamlessly integrating the critical operational areas of formulation management, traceability, production management, and quality control.

If your company lacks the IT infrastructure to do so, you should investigate modern ERP systems. No other system can connect people, processes, and data across the entire enterprise and extended Pharma supply chain as quickly and efficiently as modern ERP. For more information, contact us today.





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