GE Healthcare's Victor Bornsztejn offers insight to help companies achieve more efficient validation, which ultimately leads to a wide range of benefits including cost containment, reduced approval times and assurance of traceability.
Q1: What are the main issues with how manufacturers are currently validating their facilities and what impact do they have?
Manufacturers must achieve regulatory compliance of facilities, laboratories and equipment more efficiently (i.e., faster, with standardized documentation, elimination of unnecessary work, reduction of errors, etc.). Current facility validation processes are based on traditional models where validation tends to start during or after facility design and ends with the handover of the facility. In our opinion, this validation effort begins too late and can lead to significant issues such as lack of transparency and standardization, and validation projects running over-budget and over-time. Many manufacturers start by putting together a very large and detailed site validation master plan (VMP) that contains a plethora of information such as:
Such a bulky VMP is difficult to write, review and maintain, making it difficult to control and, subsequently, close-out (complete) projects. Critically, this style of VMP is not a flexible document and usually needs constant revisions and rewrites. The impact can be incredibly significant as new facilities suffering delays in the go-live date can lead to delays in product manufacture, resulting in additional costs and loss of revenue.
Q2: What facility validation services do GE Healthcare offer?
We believe there is a disconnect between drug/process development, validation of facilities and ongoing facility compliance management. This is why we have launched a global service for complete facility validation for new or existing builds, including all facilities, utilities, equipment, computer systems etc.
We understand that many manufacturers work against a background of high activity with a proportional level of supporting documentation. Therefore, we have introduced a Modular Validation Platform (MPV) that allows manufacturers to benefit from the development of a workable and economic validation policy that is compliant with all current and foreseeable initiatives. It minimizes exposure of surplus information, while optimizing the level of control and ease of inspection. It also provides a springboard for future validation programmes.
Our approach is for planning to start before the facility has been designed. It involves thinking about validation holistically and not developing detailed documents too early invariably they will need modifying and adapting as the validation programme progresses. We start putting together a modularized document/master plan that begins with the high-level detail (e.g., setting out intent and broad observations) and then building in other details as the facility design and construction progresses (Figure 1). We use automated document generation software to make the process faster and more accurate, and all validation decisions are supported by a unique regulatory database; together these provide an efficient compliance status capability with full traceability.
Q3: What benefits are provided by using your Facility Validation approach?
There are a number of advantages to the MVP compared with traditional facility validation strategies, including:
As part of overall project management, we also apply operational excellence methodologies such as Lean and Six Sigma where appropriate.The main point to stress here is that our approach focuses on building long-term relationships with customers through sharing our experience and expertise across the entire product and facility life cycle. This can help reduce approval times, which means facilities can go on-line earlier and products can get onto the market quicker. It also enables customers to become more self sufficient for the future.
Q4: Do you believe your customers and potential customers have enough industry knowledge about facility validation?
We believe that industry knowledge is highly variable and dependent on one critical factor resources. Validating a facility is expensive in terms of costs, personnel and time. Many people in the industry do not understand how poorly validation can be managed, and how much time and money could be saved if facility validation was effectively planned during facility design, initiated BEFORE the facility is being built and efficiently executed during and after facility construction to ensure timely completion of validation reporting and, ultimately, facility approval by regulators.
Q5: What are the main issues faced by your customers?
The biggest issue is regulatory compliance. Poorly or incorrectly validated facilities, processes and life cycles cost manufacturers millions of dollars in lost product and time. Customers are regularly receiving citations and warnings that are linked to their validation, or lack thereof, usually for reasons that can be avoided by use of a holistic validation strategy.
Q6: At which point in the life cycle do you get involved?
For new facilities, we ideally need to be involved right from the start at least when customers are planning their new facility. We can start in an advisory capacity even before a decision has been made on a new facility, which allows an ideal risk-based approach to be built from the beginning. Otherwise, we can come in at any stage as we can also work with existing facilities that need to update/review their validation programmes.
Q7: How do you see facility validation developing in the future?
There is a lot of discussion regarding ‘risk-based’ validation and regulatory authorities are advocating the use of this type of approach. However, as an industry, we are still some way from fully realizing that. Inevitably, the industry will develop strategies to use risk-based approaches to manufacture and validation. We’re also going to see early process development become more important (e.g., improved process knowledge enabling PAT-driven processes) and more leveraging of automation to drive document generation and project management. The onus is on companies, such as ourselves, to help educate manufacturers in how to validate early and validate correctly which can ultimately make a huge difference to their business.