What is Validation for Pharmaceutical Manufacturers?

Published June 15 2021

When considering pharmaceutical validation, it’s easy to get wrapped up in technical speak and legal jargon. You can think about validation the way you think about making a cake. You want to be certain that you’re following the recipe exactly, making sure that every step in the cake-making process is done exactly the same every time, so that each finished cake has the same look, taste and quality.

What is Pharmaceutical Validation?

In pharmaceutical manufacturing, it’s critical to meet government regulatory guidelines and produce safe, quality products in the most cost-efficient way possible. The validation process ultimately provides documentation that the processes in place function according to your pre-set manufacturing specifications to produce the correct drug every time. Validation provides proof that you tested your process, how you tested it, and what happened during the testing. This helps to make sure the outcome meets the desired requirements. Sticking to requirements ensures consistency, safety and quality throughout the manufacturing process. Everything must be done the same way, repeatedly to ensure batch consistency.

Boost efficiency, reduce waste

Validation also gives manufacturers the opportunity to optimize the manufacturing process for efficiency, and minimize waste throughout the process. Lean validation uses automation to ensure repeatable processes and sustained compliance. Aim to eliminate manual processes. Take a long look at existing processes, thinking about KPIs and overall goals, and consider how each step contributes to that goal. Eliminate steps in the manufacturing process that do not add value.

Data First

In September 2019, the FDA released its Technology Modernization Action Plan, which puts an emphasis on data, infrastructure and collaboration, not stacks of documents. Health Canada is also planning ways to modernize the regulation of clinical trials. For pharmaceutical manufacturers, managing the validation process digitally can automatically keep a detailed paper trail for regulatory purposes. Today’s systems grow more demanding and complex from a compliance perspective

Data integrity is important, and having a modern, validated system can help with tracking and traceability in the event of a recall.

Moving to the Cloud

Can you be secure in the cloud? Yes! The process for validating cloud systems is different, but the basic principles still apply. Microsoft’s Azure cloud is secure, redundant, and used by 90% of Fortune 500 companies. Having a system that’s in the cloud can also support remote access and data sharing while remaining secure. Although a manufacturer cannot completely eliminate the potential for a cyber-attack, organizations can minimize the probability through their validation strategy.

Would you like to learn more? Download our guide to Validating Microsoft Dynamics 365 and Azure to get an in-depth look at ways to validate your system in the cloud.