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-valueadded 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 equipment, automated manufacturing systems, validation programming
information and validation status information) are detailed and mapped out from the start of the validation phase in a large
and intricate site validation master plan (VMP). This approach does not necessarily employ a validation team, which would
help ensure the planned project delivers the necessary evidence to support facility and process approval. Additionally, because
the VMP is used as a repository for all validation-impacting information, it is hard to compile, control and maintain, making
it difficult to complete projects. Critically, the VMP is not a flexible document and needs constant revisions as the construction
of the facility progresses, which can lead to delays in golive dates and product manufacture. There is usually little or no
link to process development and process understanding; because important validation decisions are not necessarily based on
the critical quality attributes of the product to be manufactured in the facility. This can result in non-valueadded validation
effort and missing required work.
A modular approach
Figure 1: Traditional facility validation programmes.
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The drawbacks of traditional facility validation methods result from a disparity between drug/process development, facility
validation and ongoing facility compliance management. A carefully planned modular approach, however, can avoid these issues
and increase the efficiency of achieving regulatory approval, thus improving the ability to complete projects on time, as
well as assisting cost containment and supporting the use of standardized methods for enhanced documentation accuracy. A modular
approach will also help minimize exposure to surplus information, while optimizing the level of control and ease of managing
the compliance inspection process; for existing facilities, it minimizes the impact of change.
Compliance
Implementing a modular validation platform results in a validation process that is compliant with all current regulations,
and provides a springboard for future-orientated regulatory initiatives. This includes standards and directives such as the
FDA's Pharmaceutical cGMPS for the 21st Century — A RiskBased Approach and the ICH Q8, Q9 and Q10 guidelines, which demonstrate regulators' desire to use risk-management strategies to support
all manufacturing and control activities.The ASTM E2500 guideline is already taking this a step further by steering validation
towards a continuous verification process that is inherently risk-based, underpinning all decisions with detailed process
and product knowledge.1
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