Reduce Validation Cost

The traditional pharmaceutical validation process in the pharmaceutical industry is time-consuming and not very cost-effective. There are various factors that can lead to increased costs and unnecessary delays in validation. Some of these factors include inefficient analytical testing procedures, excessive number of approvals and personnel required to verify documents, repetition and rework.

All national and international standards of FDA (Food and Drug Administration) and EMA (European Medicines Agency) must be strictly followed in the validation process. Product validation and integrated verification processes also ensure that Good Manufacturing Practice-GMP standards are met.

While it is important that these practices conform to GMP requirements, there are ways in which this tedious process can be bypassed without compromising safety or quality. Some common factors that are overlooked and increase costs during the validation process.

1. Approval Number:
The first and foremost step that can be taken to reduce costs and reduce time delays is to limit the number of staff involved in document approval. The required number of approvers is not expressly stated anywhere in the regulatory requirements and thus may be limited to a minimum number of document reviewers. This ensures that work is completed much faster, reduces capital costs and provides a consistent, reliable end result.

2. Repetitive Activity:
Certain activities are often repeated during qualification. Duplication of such operations occurs during commissioning to ensure safety and quality. But in reality, it only adds cost and time without any added benefit. Thus, procedures that are often repetitive in nature can be carefully analyzed and avoided by integrating these interconnected processes and ensuring a proper communication channel between the concerned authorities.

3. Avoid paper work:
With the development of technology, it is now possible to avoid paper validation and provide quick results. Through the use of technology, it will also be possible to run electronic protocols with global collaboration between sites. It also eliminates the need for manual verification and the process can easily be automated and prove to be more efficient. Therefore, instead of going through the cumbersome task of creating and managing paper documents, its soft copies can act as a boon in the management sector besides cost reduction. This reduces the risk of errors and provides reliability.

4. Risk assessment:
Risk assessment is a primary factor influencing the cost of pharma validation. Risk assessment must be done for systems and procedures that may have direct or indirect impact on product quality. Some firms have an informal process for such evaluations and spend a lot of time in meetings and discussions, which increases the cost of validation. To avoid these inefficiencies, it is necessary to have a precise, organized procedure to follow. Standardized assessment methods may be a possible solution to this problem.

We can make the validation process more efficient and cost effective by following some techniques. Traditional validation processes have some room for improvement in terms of efficiency and cost reduction. The integration of different processes which implies repetition can be efficiently avoided thereby reducing validation costs and time in the pharmaceutical industry.

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