Can Pharmaceutical Companies Turn Validation into a Competitive Advantage?


Many companies view validation as a cost of doing business. They see it as a necessary component of compliance. However, validation can be a way for your organization to develop a competitive advantage over the rest of the industry.


If you view validation, as more than a way to make sure that bare minimum requirements are met, and instead as a way to ensure that your systems are running at peak efficiency, you'll be able to dominate the competition.


Changing Validation Mindset


Validation is more than just the cost of operating in the pharmaceutical or biomedical industries. Your entire organization needs to begin seeing validation as not a cost, but an investment in your supply chain, manufacturing, and logistics.


Regulators want to ensure that all manufacturing processes produce a consistent and replicable result. Their goal is to prevent defective products from being introduced into the logistical chain at any point.


But, validation can also be used to make sure that you are eliminating waste and minimizing risks. Validation can be about modernizing every aspect of your business so that it runs smoother than any of your competitors. It is a way to make sure you are taking full advantage of AI and Automation.


Standard Validation Process


Traditionally, validation is viewed as having three components:


  1. You need to make sure that you are creating an evidence trail.

  2. That shows any action process or system.

  3. Leads to a consistent, replicable result each time.


While you can create a validation process internally, it is challenging to get an objective result. It is human nature to overlook our own mistakes.


The best way to create an effective validation process is to use outside experts. You need someone who understands not only the pharmaceutical manufacturing industry but who also is intimately familiar with the different regulatory requirements and best practices for the industry.


You can use a team of experts to not only make sure you meet the minimum requirements of regulators, but also to meet higher efficiency requirements. This will be a step ahead of your competitors.


Anyone you bring into to help with validation needs to be able to work on:


  • Computer and machine vision inspection

  • Packaging lines with serialization systems

  • Computer systems and equipment


You want this process to be simple and cost-effective. Before any inspections or validation begins, you need a master validation strategy. It takes time to create a validation plan and strategy. You will then need to work with a team to develop the validation protocols and the execution of validation.


Increasing Validation Efficiency


If you want the validation to be as efficient as possible, then you need to work with the experienced experts who spend the time familiarizing themselves with your manufacturing processes. They should already be familiar with regulatory validation requirements and industry best practices.


Most importantly, you need to work with validation experts who understand the importance of planning. The old cliché that every carpenter and seamstress lives by, “Measure twice, cut once,” is also excellent guidance for pharmaceutical validation.


The more thorough the planning and strategy stages are, the smoother the rest of the validation process will be.


When there are errors in the validation process, they can usually be traced back to a lack of proper preparations.


Looking at Validation Holistically


There are a lot of different components of a thorough validation.


Depending on your company, you may need to account for:


  • Pre-FAT

  • Factory Acceptance Test (FAT)

  • Pre-SAT

  • Site Acceptance Test (SAT)

  • Commissioning

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Verifications​ & Validation (V&V)

  • Computer Systems Validation (CSV)

  • Validation Experts Certified in Serialization


However, to get the most benefit out of the validation process, you also need to view those the validation process holistically. You have to see how each component works with all of the other components as part of a unified system with the goal of producing the best quality product in the most efficient manner, every time.


You are looking to make validation not just a step in your compliance process, but a competitive advantage.


This means you are looking to smooth out any communication, transportation, manufacturing, or inefficiencies from the system.


Vanguard Vision understands the complexity that goes into validation. We are committed to helping our clients not only comply with all relevant regulations, but to turn their entire machine vision inspection systems, packaging lines with serialization technology, computer systems, and equipment into a cohesive and efficient unit.

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