Validation considerations for serialization

As a rule of thumb, validation adds 25% to the cost of any changes required by serialization.

One way to get a leg up on validation is to rely on vendors that can provide the engineering resources to create the required validation documentation. Such documentation should include the serialization qualifications, operational qualifications, and acceptance test protocols. The vendor should have the ability to execute those protocols.

Another technique is to follow Good Automated Manufacturing Practice (GAMP) and develop a User Requirement Specification (URS) that may form the basis for future validation materials. 

The vendors, not the user companies, are the ones most knowledgeable around how their systems work. If the vendor does not provide validation documentation, then the pharmaceutical company must hire a third-party validation company that is not familiar with the technology. While those firms understand commodity technologies, they are unlikely to be familiar with specific serialization technologies, resulting in a cost exposure for the manufacturer.

Another potential problem exists for the many pharmaceutical companies that handle validation differently at the corporate level versus at the plant level. A plant-level validation change might require three signatures: the person initiating the change, one level up, and the plant manager.

A validation change at the corporate level—say for a change in a business process—may require 15 or 20 signatures. That’s two weeks versus two days. That two-week process simply won’t fly with all the changes that serialization requires. As a direct result of dealing with serialization, some companies are issuing revised internal procedures for how they handle validation changes at the corporate level, to streamline such validation changes.

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