Pharmaceutical validation & beyond: Creating a trusted supply chainPublished on Pharmaceutical Processing (http://www.pharmpro.com)

Pharmaceutical validation & beyond: Creating atrusted supply chain Jim Lee, Vice President of Product Management, Systech

The ability totrack raw material sources before they hit the manufacturing line adds a criticallayer of supply chain security. After all, no one wants saw dust turning up in babypowder.

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

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

Page 1 of 4

Pharmaceutical validation & beyond: Creating a trusted supply chainPublished on Pharmaceutical Processing (http://www.pharmpro.com)

Read: A Comparative Framework Between New Product and LegacyProduct Process Validation [1]

Qualification is an inherent part of validation and is the action of proving -- inaccordance with the principles of GMP -- that any equipment, material, facility orsystem is able to achieve the expected results.

As an example, the FDA defines process validation as the collection and evaluationof data, from the process design stage through commercial production, whichestablishes scientific evidence that a process is capable of consistently deliveringquality product. Process validation involves a series of activities taking place overthe lifecycle of the product and process with the goal of identifying potentialhazards, failures and contamination.

In short, validation is an integral part of quality assurance. However, it doesn’tnecessarily secure the supply chain by collecting the necessary data points thatprovide visibility from the origination of raw materials to their final destination.

Systech sees the future of validation going far beyond this finite definition as itrelates to quality assurance. As we migrate toward a better, more effective meansof validation, manufacturers will seek documentation to help ensure thatsystems, facilities and processes deliver uniform batches, which will meet requiredspecifications and subsequent approvals.

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

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

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

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

Page 2 of 4

Pharmaceutical validation & beyond: Creating a trusted supply chainPublished on Pharmaceutical Processing (http://www.pharmpro.com)

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 themanual sampling of raw materials. However, most QC departments simply don’thave adequate manpower to do this. Moreover, even if they did, it doesn’tnecessarily provide enough data to identify the actual source issue or the specificgoods impacted. This leads to large recalls as only the batch can be identified,which can potentially be millions of units.

What needs to be doneThe supply chain needs to be secured from end to end. Serialization has gone along way to provide a form of identification for packaged items; typically at a batchlevel, enabling manufactures to issue recalls on a wide scale. Combined with track-and-trace technologies, the post-production supply chain can potentially be securedwhen 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 doubtjust a matter of time. If you look to non-pharma industries such as consumerelectronics, most major brands have implemented process, procedures and systemsto secure their supply chains to such an extent that it has become commonplace forthem to be able to issue recalls against individual products for specific faultycomponents.

Pharma and life sciences can learn from the consumer product companies and reapcritical 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 serializationand 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.

Page 3 of 4

Pharmaceutical validation & beyond: Creating a trusted supply chainPublished on Pharmaceutical Processing (http://www.pharmpro.com)

5. Deploy anti-counterfeiting and authentication solutions.

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

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

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

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

Source URL (retrieved on 07/24/2015 - 9:36am):http://www.pharmpro.com/articles/2015/07/pharmaceutical-validation-beyond-creating-trusted-supply-chain

Links:[1]http://whitepapers.pharmpro.com/20141027_pharmatech_comparative_framework/?

Page 4 of 4