Reduce Validation Cost in Pharmaceuticals

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 delay in the validation. Some of these factors include inefficient analytical testing methods, an excessive number of approvals and personnel required to validate documents, repetition and rework.

All national and international standards of FDA (Food and Drug Administration) and EMA (European Medicines Agency) must be strictly adhered to in the validation process. Validation of products and the integrated verification process also ensures that Good Manufacturing Practice -GMP standards are met.

Though it has the importance that these practices are in compliance with the GMP requirements, there are certain ways in which this tedious process can be bypassed without any compromise on safety or quality. Some of the most common factors which are overlooked and increase the cost during the validation process.

1. The Number of Approvals:
The first and foremost step that can be taken to cut down costs and also reduce time delay is by limiting the number of personnel in the approval of documents. The required number of approvers is not explicitly mentioned anywhere in the regulatory requirements and thus can be limited to a minimum number of document reviewers. This ensures that the work gets done much faster, reduces capital cost, and provides a consistent, trustworthy end result.

2. Repeated Activities:
Certain activities are often repeated during qualification. Such duplication of activities occurs during commissioning to ensure safety and quality. But in reality, it only adds to the cost and time taken without any added benefit. Thus, the procedures which are often repetitive in nature can be carefully analyzed and avoided by combining these interlinked processes, and by 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 faster results. Through the use of technology, it will also be possible to execute electronic protocols with global collaboration between sites. It also eliminates the need for manual validation and the process can be easily automated and prove to be more efficient as well. Therefore, rather than going through the inconvenient task of creation and control of paper documents, soft copies of the same can serve as a boon in terms of cost reduction as well as to the management sector. This also reduces the risk of errors and provides reliability.

4. Risk Assessment:
Risk assessment is one of the primary factors impacting the cost of validation in pharma. The risk assessment must be done for the systems and procedures that can have a direct or indirect impact on product quality. Some firms have an informal process for such assessment and a lot of time is spent in meetings and discussions that increase the validation cost. In order to avoid this inefficiency, it is necessary to have a well defined, organized set of procedures to be followed. Standardized assessment procedures can be a potential solution to this problem.

We can make the validation process more efficient and cost-effective by following some tricks. The traditional validation process has some space of improvements with regard to efficiency and cost reduction. The integration of various processes that indicate repetition can be skillfully avoided to ensure that validation cost and time are reduced in the pharmaceutical industry.

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