Regulatory Expectations for Evaluating GMP Facilities and Equipment

Good manufacturing practices (GMPs) set by regulators in the United States (1), Europe (2), and other areas of the world (3) govern pharmaceutical manufacturing. Building and maintenance of manufacturing buildings and equipment fall under these regulations (4,5) and usually must comply with these rules in the form of risk-based maintenance programs.

Pharmaceutical Technology® spoke with David Basile, VP Technical Operations, Americas, Hovione, about the regulatory requirements for GMP facilities and equipment and how often these facilities should be evaluated for potential upgrade to ensure they meet standards.

PharmTech: GMP facilities have certain regulatory requirements. What do regulators say about the maintenance of these facilities?

Basile (Hovione): Maintenance is instrumental to what we do as a CDMO (contract development and manufacturing organization). Our ability to deliver products to our customers, and ultimately to patients, is vital. We count on having our assets available when we need them. So, at a very basic level, regulators expect us to maintain our facilities at a high level of cleanliness and in a good state of repair to prevent contamination and mix ups.

Maintenance programs in our industry require documented schedules and procedures for preventative maintenance and cleaning to ensure sustained compliance. The most recent agency guidelines emphasize the use of risk-based approaches to maintenance in order to drive focus on the most critical assets that are closest to the product. At Hovione, we take a comprehensive cradle-to-grave approach to facilities management that starts with proper specification, design, and installation through retirement, using a modular, scalable process that accelerates deployment of our critical facility and equipment assets.

How often should GMP facilities be evaluated for potential refurbishing or updating in accordance with GMP regulations?

There's no set frequency in the regulations. We use a risk-based and lifecycle approach, following industry guidance and best practices. Regular GMP walk throughs and internal audits help us proactively uncover deficiencies. We also use our annual shutdown planning cycle as an opportunity to identify and prioritize these updates. Over the long term, our capital planning cycle covers more substantial, strategic facility upgrades. Other factors that can also drive this evaluation include changes in client needs or market demands or new product introductions. For example, we might have a client that has a pipeline of potent products, in which case we would evaluate the implementation of, say, air locks or isolators or misting stations in those relevant areas. At Hovione, we know it's also critical that we continually modernize our equipment and manufacturing systems to stay ahead of the curve. So, we're continuing to upgrade our facilities by investing in the latest advanced technologies and spray drying and continuous tableting platforms and expanding our capacity here in New Jersey, strengthening the reliability of our supply in the United States.

How often should equipment that is used in GMP facilities be evaluated to ensure it still meets standards?

This is usually governed by the site's validation master plan, which covers requalification or periodic assessment of GMP equipment. The time period for each type of equipment will vary based on risk assessment, but three to five years is a typical timeframe. This entails a comprehensive review of historical changes to the equipment, failure trend analysis, and CAPA [corrective and preventive actions] effectiveness to confirm that the equipment continues to meet its original performance specifications. GMP manufacturing and lab equipment also require that regular calibration be performed more frequently with critical instrumentation. Again, we take a lifecycle approach to maintaining equipment, where the equipment master serves as a birth certificate when a machine comes in, all the way through to decommissioning. This is a fundamental part of good asset management.

References

1. FDA. Current Good Manufacturing Practice (CGMP) Regulations. FDA.gov. Jan. 21, 2025. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations (accessed Oct. 27, 2025).
2. EMA. Good Manufacturing Practice. ema.europa.eu. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice (accessed Oct. 27, 2025).
3. WHO. Health Products Policy and Standards. WHO.int. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/gmp (accessed Oct. 27, 2025).
4. ICH. Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (ICH, 2000).
5. ICH. Q8(R2) Pharmaceutical Development (ICH, 2009).

About David Basile

David Basile joined Hovione as VP Technical Operations–Americas in 2021. David has 25 years of experience as a global pharma manufacturing executive with special focus on operational excellence and engineering. During this time, he held several positions including Global Director of Engineering, Automation & Reliability at Catalent Pharma Solutions where he oversaw strategic capital expansions for several business units in the Americas. Prior to this David spent fifteen years with Teva/Actavis in a variety of technical leadership roles over the northeast US region. He holds a Master of Science Degree in Systems Engineering from NJ Institute of Technology, a Bachelor of Science degree in Mechanical Engineering from the University of Notre Dame and is a trained Lean Six Sigma Black Belt.