IQ OQ PQ & Validations in Serialization

Qualifications and Validations are the most vital process of the maintaining a healthy serialization readiness. Failure to achieve IQ/ OQ & PQs and Validations must be treated as a show stopper in serialization environment. The reason for this not just procedural or academic but very much operational.

If a Healthy Serialization environment is not maintained, it gives exposures to serious operational and integral risks, which can compromise a complete supply chain of the pharmaceutical business unit.

In order ensure satisfactory validation of the serialization environment, it is extremely important that periodic tests are run on the system. The periodic tests needs to be planned and executed both in In-process Control (IPC) operations or QC/ QA Ops, and running the system thought planned and gauged challenges in order to ensure the State of Validation.

Ensuring the State of Validation is only method to ensure that the Sterilization Environment is Healthy. Elements checked to ensure the State of Validation are mentioned below, however the list of tests/ challenges can be different according to different environment and scenarios and are not limited to the following elements:

• Software Validation; including but not limited to
  • IQ/ OQ & PQ of the Serialization Software
  • IQ/ OQ & PQ of the Serialization Hardware
  • IQ/ OQ and PQ of the Integration of Serialization Hardware and Software