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Taking the modular approach for effective facility validation: when validating a new facility or revalidating an existing one, many pharmaceutical and biopharmaceutical companies use a traditional and complex model that is costly and time intensive, a modern strategy that uses a modular approach could avoid these issues and help manufacturers achieve effective and economical compliance.

Article Excerpt
Despite the fact that regulatory compliance is fundamental to the pharmaceutical industry, too many manufacturers lose millions of euro in revenue because of poorly or incorrectly validated facilities. With increasingly demanding global regulations and guidance, rising manufacturing costs and dwindling product portfolios, it is vital to achieve efficient and effective compliance of facilities, processes and equipment to retain market competitiveness.

Enhanced facility compliance (e.g., optimizing go-live dates, implementing standardized documentation, reducing errors and using risk-based strategies to minimize non-value-added work) can be achieved by switching from the traditional method of validation to a modern modular approach that helps complete projects on time, assists the containment of cost, and supports the use of standardized methods that improve the accuracy of documentation.

The traditional approach

Currently, traditional facility validation programmes are complex, and the planning and execution phases are often initiated too late in the process (Figure 1). If the validation strategy is not agreed early enough (a common issue), it can contribute to projects running over budget and over time, which means facilities do not go live as scheduled and product manufacture is delayed.

Under the traditional method, major facility components (e.g., process descriptions, documentation standards, protocols, standard operating procedures [SOPs], critical utilities, process...

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