The ability to track raw material sources before they hit the manufacturing line adds a critical layer of supply chain security. After all, no one wants saw dust turning up in baby powder.

What is the difference between validation and qualification?  Very often, the terms are intermingled.  To help clear the confusion, “things” are qualified, while the ways they are “used” (processes) are validated. Validation aims to solve a single problem:  accelerating approval from regulatory bodies in order to bring a product to market.

Validation by definition is the action of proving — in accordance with the principles of GMP — that any procedure, process, or activity will consistently produce a product that meets specifications within set quality guidelines.

Read: A Comparative Framework Between New Product and Legacy Product Process Validation

Qualification is an inherent part of validation and is the action of proving — in accordance with the principles of GMP — that any equipment, material, facility or system is able to achieve the expected results.

As an example, the FDA defines process validation as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process with the goal of identifying potential hazards, failures and contamination.

In short, validation is an integral part of quality assurance.  However, it doesn’t necessarily secure the supply chain by collecting the necessary data points that provide visibility from the origination of raw materials to their final destination.

Systech sees the future of validation going far beyond this finite definition as it relates to quality assurance.  As we migrate toward a better, more effective means of validation, manufacturers will seek documentation to help ensure that systems, facilities and processes deliver uniform batches, which will meet required specifications and subsequent approvals.

In addition, it is Systech’s view that it is becoming ever more important to focus on the origins of raw materials so they can be traced back through the supply chain prior to manufacture –including being able to validate authenticity to address questions like: Is this a real shipment?  Was our supply chain contaminated or infiltrated?

The risks
In order to bring a drug to market, procedures for each step in a drug’s creation and how it will be consistently, repetitively produced — backed by scientific evidence — is validated. However, as the product moves and scales into the manufacturing cycle, the risks associated with producing multiple batches in a variety of locations introduce a myriad of pitfalls, specifically around contamination.

This is becoming more apparent with the steady growth of counterfeiting, which is fueled by the general trend demand on firms to do more with less (increase profits).  The use of lower cost materials combined with an increase in outsourced manufacturing in a rush to meet evolving compliance guidelines can be a recipe for disaster.

At this point, the risks start to scale exponentially as contaminants begin to enter the supply chain at various stages in the process, from the sourcing of raw materials all the way to packaging, before they even enter the distribution chain. The consequences often lead to:

• Inferior quality products.
• Bulk recalls.
• Quarantined product.
• Loss of revenue and market valuation.
• Brand and reputation damage.

The way quality control for validation is handled today is typically through the manual sampling of raw materials. However, most QC departments simply don’t have adequate manpower to do this. Moreover, even if they did, it doesn’t necessarily provide enough data to identify the actual source issue or the specific goods impacted. This leads to large recalls as only the batch can be identified, which can potentially be millions of units.

What needs to be done
The supply chain needs to be secured from end to end. Serialization has gone a long way to provide a form of identification for packaged items; typically at a batch level, enabling manufactures to issue recalls on a wide scale. Combined with track-and-trace technologies, the post-production supply chain can potentially be secured when all partners in the process leverage a common automated system. 

Unfortunately, when it comes to raw materials, serialization is not currently applied, nor is it legislated. However, due to the issues previously discussed, it’s no doubt just a matter of time. If you look to non-pharma industries such as consumer electronics, most major brands have implemented process, procedures and systems to secure their supply chains to such an extent that it has become commonplace for them to be able to issue recalls against individual products for specific faulty components.

Pharma and life sciences can learn from the consumer product companies and reap critical benefits such as:

1. Ensuring consistent quality.
2. Reducing costs associated with recalls.
3. Continuously building brand trust.
4. Controlling counterfeiting.
5. Real-time authentication.
6. Developing consumer engagement channels (consumer/retailer).

How?
Take a page out of the anti-counterfeiting book and combine it with serialization and track-and-trace to create the ultimate secured supply chain.

1. Serialize the product and packaging lines (required for compliance).
2. Implement track-and-trace, extending it upstream to shipping and distribution utilizing Internet-enabled technologies.
3. Implement track-and-trace technologies with raw goods/material providers.
4. Integrate with QMS to support validation.
5. Deploy anti-counterfeiting and authentication solutions.

From the creation and packaging of raw materials, through shipping and into production and upwards through the supply chain, it now becomes possible to pinpoint a specific product at any point in its lifecycle, providing not only supply chain security, but also business intelligence and insight.

By building an ecosystem of suppliers, CMOs and CPOs that leverage these technologies to build a secured supply chain, manufacturers make validation simpler and quicker; while at the same time increase their flexibility.

This level of visibility allows manufactures to know, in real time, where the core ingredients originated and where those ingredients are, by product, location, stock levels, etc. This gives them a competitive advantage in controlling and reporting on supply chain diversion, infiltration and gray markets. 

Taking it one step further, this technology can enable consumer engagement by encouraging consumers to ‘scan’ their medication when they take it, providing a feedback loop to deliver drug information on interactions, etc. and enable automatic re-ordering. Most importantly, it can quickly and efficiently notify end-users of a recall!  The possibilities are endless and a game changer for the pharma industry as a whole.