State of Validation in Serialization

Maintaining Validation in a serialization operation is one of the most important tools to ensure Quality In-Process Operations. The goal of understanding and maintaining the State of Validation is to ensure a continued Process Validation. The overall verification the maintenance of the Validated State includes:

• Perform reviews, evaluations, actions and follows up on the manufacturing processes continuously
• Secure that all aspects with potential impact on the validated state are evaluated and documented
• Assess and evaluate impacts of changes (improvements and/or adjustments) to the process.

While the Drug Regulatory Authority of Pakistan remains mute on this; As per GMP standards, state of Validation of the manufacturing hardware should be conducted and maintained annually. However Serialization Operation demands a more rigorous approach towards maintain the state of Validation. Therefore the Validation checks are more frequent needed to be done on the Serialization Infrastructure. The reason to conduct frequent check are due to the nature of the operation. As Serialization is a mix of Data Management as well as Hardware, Corrective & Preventive Maintenance Actions (CAPA) is required to be more rigid.

In order to initiate and maintain the state of validation, the validation checks needs to more frequent. They need to be split to a frequency of timelines along with designing activities to challenge different scenarios at the manufacturing setup.

The timelines needs to be split into weekly, monthly, quarterly and annual checks. All the timelines need to have different levels of challenges built to verify the state of validation. The challenges are usually a combination of hardware and software tests, which ensure the stability, integrity, security and efficiency of the serialization infrastructure.

The activity just does not ends there. Along with putting the Serialization Infrastructure through a series of the tests and challenges, the State of Validation needs to be communicated to IPC Operations at the manufacturing facility for purposes of Quality Control as part of a Standard Operating Procedure. The Latest State of Validation is used as a reference to release the manufactured batch/ stock from Quarantine/ Commercial & Trade Release.

DRAP requires all pharmaceutical products to be compliant to SRO 470(i)/2017 by June 2019. While some companies have taken a head-start, many companies need to start urgently to meet the deadline to be able to distribute and sell their products in Pakistan.