GMP-Compliant Maintenance: A Pillar of Process Control
In Good Manufacturing Practice (GMP), the third phase of process validation—continued process verification—ensures that your process remains in a state of control. However, maintaining this state is not static; it requires proactive management throughout the lifecycle of your facility.
From the initial equipment qualification and process validation, many changes will inevitably occur. Equipment ages, once-new systems become outdated, and regulatory requirements evolve. Additionally, sustainability initiatives or technological advancements may necessitate equipment revamping, whether due to obsolescence in HMIs and computerized systems or a need for improved efficiency.
Regulatory Expectations for Maintenance
Both the FDA and EMA emphasize the importance of equipment maintenance and documentation as part of ensuring compliance and product quality:
- FDA 21 CFR 211.67 mandates a written maintenance schedule and requires that equipment be kept clean and functional to prevent contamination or malfunctions.
- FDA 21 CFR 211.68 stresses the need for routine calibration and maintenance of computerized systems.
- EMA EudraLex Volume 4, Chapter 3 (Section 3.2, 3.34 & 3.35) states that premises and equipment should be maintained in a way that prevents hazards to product quality, ensuring their suitability for intended use.
- EMA Annex 15 (Section 3.9 & 3.11) highlights the importance of maintenance, calibration, and qualification of equipment, reinforcing that proper upkeep is necessary to sustain compliance and operational efficiency.
The Role of Good Engineering Practices (GEP) in Maintenance
Managing equipment ageing and upgrades could impacts your facility’s compliance and operational reliability. Good Engineering Practices (GEP) in maintenance ensure that all modifications, replacements, and upgrades align with GMP expectations. A structured maintenance strategy not only helps sustain process control but also minimizes deviations, unplanned downtime, and compliance risks.
By integrating preventive and predictive maintenance, along with robust change management procedures, pharmaceutical manufacturers can uphold data integrity, product quality, and regulatory compliance—ensuring that their facility continues to operate within a validated state.
Do you want to learn more about GMP-Compliant Maintenance?
Join The Pharmaceutical Maintenance Symposium 2025 and start driving industry best practices.
Recognising the critical role of maintenance in ensuring GMP compliance, operational efficiency, and process reliability, No deviation launched the Pharma Maintenance Symposium—a unique platform where equipment, compliance, and process experts come together to share best practices and innovative approaches.
The symposium serves as a networking hub for the industry to discuss current challenges, regulatory expectations, and technological advancements in pharmaceutical maintenance.
By bringing together engineers, maintenance managers, validation experts, and regulatory professionals, the Pharma Maintenance Symposium reinforces the importance of structured maintenance programs, ensuring that the industry continues to meet GMP standards while optimizing performance and compliance.
