Key Takeaways

• Multiple departments, including engineering and quality assurance, are responsible for evaluating GMP equipment and facilities.
• Regulatory inspectors require well-organized, preferably digital, maintenance documentation during GMP audits.
• A computerized maintenance management system (CMMS) is crucial for tracking maintenance activities and ensuring high performance.
• Common mistakes include neglecting criticality assessments, relying solely on time-based maintenance, and failing to consider maintainability during design.
• Adequate commissioning time is crucial for equipment lifespan and maintenance reliability.

Construction and maintenance of manufacturing buildings and equipment fall under good manufacturing practices (GMPs) regulations (1–5). Pharmaceutical manufacturers can comply with these rules in the form of risk-based maintenance programs. Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance.

PharmTech: Which department is responsible for evaluating GMP equipment and facilities?
Basile (Hovione): The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance.

Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency?
Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience.

Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance.

What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities?
Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly.

Another mistake might be failing to consider design for maintainability during upgrades and not during the design phase. Adequate space and access to equipment, standardized tools, having the right pickups on equipment for condition-based maintenance [are important considerations]. I can't tell you how many times I've seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it. Failing to consider design for maintainability and not bringing maintenance in during the design phase is one mistake that people often make.

Not carving out a role for a dedicated maintenance planner is also a misstep. At Hovione, we have a dedicated reliability engineer and maintenance planner that help in the evaluation. This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution. These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands on experience. In fact, the best planners are usually seasoned mechanics.

One final failure we see often is not building in enough time for commissioning. The lifespan of equipment can be greatly influenced during the commissioning phase. This is where maintenance reliability starts. Too often, commissioning is rushed through, and equipment and preventive maintenance plans and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis.

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