Engineering design and delivery is pivotal to pharmaceutical manufacturing, by ensuring systems that are successful, safe and cost-efficient. Good Engineering Practice (GEP) is integral to Good Manufacturing Practice (GMP). Our Engineers work closely with Product Developers, Regulatory Specialists, Quality Assurance Professionals, equipment manufacturers and Validation Specialists to ensure that new drug manufacturing systems or upgrades meet all of the regulatory requirements and operate at the highest levels of efficiency and reliability.

Benchmark Quality Systems Engineers can bring the following skills and expertise to your project.

Project Management and Integration

• Multidisciplinary Coordination of project stakeholders, including the architects, specialist consultants, construction teams and equipment suppliers to ensure a smooth integration of all design elements.

• Timeline and Budget Management to ensure that the project is delivered on time and within cost constraints.

• Commissioning, Installation and Start-Up Support of new facilities or equipment and providing support to troubleshoot and resolve issues that may arise during these phases.

Facility Design and Layout

• Conceptual and Detailed Design by working closely with the architect/designers to develop facility masterplan that maximizes space utilization, workflow efficiency and compliance with Good Manufacturing Practice (GMP).

• Cleanroom Design: Coordinated cleanroom design for temperature, humidity and particulate levels to meet the required environmental control classification (inclusive of appropriate air handling systems, filtration systems and pressure differentials).

• HVAC System Design: Coordinated design of specialized heating, ventilation and air conditioning (HVAC) systems to maintain the required environmental conditions.

• Utilities and Infrastructure: Coordinated design of essential utility systems, e.g., purified water, clean steam and compressed air systems.

Process Design and Optimization

• Process Flow Diagrams (PFDs) and Piping & Instrumentation Diagrams (P&IDs) developed to outline the production processes, including equipment, piping and control systems.

• Process Optimization studies conducted to optimize efficiency, yield and cost-effectiveness, while ensuring compliance with quality and regulatory standards.

• Equipment Sizing and Selection of appropriate equipment based on process requirements, capacity and efficiency considerations.

Compliance

• GMP and Regulatory Compliance assured to guarantee product safety and efficacy.

• Validation and Qualification performed in conjunction with Validation colleagues to meet regulatory compliance.

• Risk Assessment and Mitigation performed, e.g., Hazard Analysis and Critical Control Points (HACCP) and Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential design risks.

Automation and Control Systems

• Data Integrity and Security of process control systems are secure, accurate and compliant with regulatory requirements for electronic records and signatures, e.g., 21 CFR Part 11.