Supply Chain Validation
Qualification of the Supply Chain from origin to destination.
Supply Chain Validation

Validation is the process of checking if something satisfies a certain criterion. Examples would be: checking if a statement is true (validity) or if an appliance works as intended. Validation implies one is able to testify that a solution or process is correct or compliant with set standards or rules.

Validation should not be confused with verification. Validation can sometimes be measured by applying procedural objectivity, but verification is usually subjective - a judgment call. An easy way of recalling the difference between validation and verification is that validation is ensuring "you built the right product" and verification is ensuring "you built the product right."

In the pharmaceutical and biotechnology industry, validation (drug manufacture) refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. Regulatory bodies in the European Union, U.S., and Japan (amongst many others) require validation causing it to become its own sub-industry supporting the pharmaceutical, biotechnology, and medical device industries.

Validation is important because it disallows data that cannot possibly be either true or real to be entered into a database or system.

Macaw Supply Chain Validation
Regulations that govern the manufacture of drugs and medical devices are constantly becoming more complex. At the same time regulations governing the controlled movement of manufactured product, whether in an ambient or refrigerated environment, are set to increase at a rapid rate.

At Macaw we work closely with our customers adhering to regulatory requirements and establishing quality standards that can be consistently achieved throughout their supply chain on a global basis.
Through the development, practical execution and results analysis of written protocol documentation we achieve validated supply chain routes that incorporate protective temperature sensitive measures. The protocol containing defined acceptance criteria represents a researched and approved written plan to be tested and made secure with documented results.

By establishing a robust methodology ensuring product integrity from origin to destination Macaw validation provides documented evidence that a specific process will consistently conform to its predetermined specification and quality attributes.

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