In our industry, there exists an expectation for a facility to be purpose-built to our specifications. At the same time, regulators are keen to ensure companies demonstrate that their facilities are suitable. However, with mergers/acquisitions, as well as cost-cutting initiatives, facilities are being shut down and product lines consolidated into existing facilities—risking sub-optimal layout and design.
The professionals tasked with reconfiguring these facilities certainly do not mean to achieve suboptimal results that fail regulatory scrutiny, but it happens more often than you would think. Retrofitting needs to be assessed with the same discipline and green-field approach as a new facility – i.e, with precision. Too often, though, a “let’s see if we can make this work” daredevil approach creeps in when the task is “just a retrofit.”
The placement of products into facilities not initially built for purpose does not necessarily present an objectionable practice if we understand the product and process requirements, and more importantly, the impact of the proposed new product/process within the facility.
Contamination control for both microbial and chemical cross-contamination is an often-overlooked assessment that should occur each time we plan to bring a product into a facility. It must also be a standard part of our change control process for new product introduction. The European Union has already issued instructions requiring the use of Quality Risk Management (QRM) principles to assess and control the risk of cross-contamination. These requirements are contained in the EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Part 1, Chapter 3: Premises and Equipment, and Chapter 5: Production.
The risk assessment should start with understanding the new products’ vectors of contamination, and how these can impact existing products and processes in the facility. The risk assessment should consider the current design of the facility, and how this may be sufficient (or deficient) to exclude the introduction and transmission of organisms and chemicals. This stage presents the perfect opportunity to correct deficiencies as corrections made during this phase occur before there is an adverse impact on existing operations.
The best way to truly appreciate this is to see with your own eyes real-life examples of repurposed rooms that professionals tried to “make it work”, only in retrospect the missteps they made along the way. In Part 2 of this blog (just scroll to the next blog), I recount some of these examples in the hope that they help you avoid similar difficulties. Remember, the greatest risk in repurposing an area is lacking a full understanding of the original design.
QxP Vice President Bob Ferer is a 30-year veteran in pharma. Prior to joining QxP, Bob worked with Sanofi Pasteur on a building / process train renovation. His role for Sanofi was to support the team from a compliance and regulatory aspect for the testing, qualification, and validation for all critical utilities, equipment, systems, and processes. Bob’s experience and insights have been very valuable to QxP clients.