Facilities and Equipment

Facilities and Equipment are critical to ensuring an operation meets cGMP expectations and they provide the Quality Unit the confidence that the site or company is operating within the regulatory framework.

This highly interactive course, is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

On completion of this course delegates will know and understand:

• The principles of design of a drug product facility
• cGMP as it relates to engineering activities, such as calibration and maintenance
• The modern concept of facility/utility/equipment qualification and process validation and introduced regulatory expectations
  
• How to gain process understanding and how this links to effective process validation
• The key components expected for effective facility/utility/equipment qualification and process validation:
  • Facility design and qualification of equipment and utilities
  • Process performance qualification
  • Change management

The high-level principles of design of drug product manufacturing facilities, including utilities

The Concept of Process Validation

Current Regulatory Expectations

• The impact of ICH Q8, 9, 10, 11 and Q12
• The FDA guidance on process validation
• The practical expectations for a three-stage approach involving process design, equipment and process qualification and ongoing process verification

How to Gain Process Understanding (FDA Stage 1)

• Identification of critical quality attributes (CQAs) and critical process parameters (CPPs)
• Developing and applying a control strategy for process validation

Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1)

• Writing and documenting a user requirements specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)

Process Validation/Process Performance Qualification (PV/PPQ) (FDA Stage 2.2)

• The importance and content of protocols
• Setting of acceptance criteria
• When to begin to commercialize (how many batches?)
• Understanding residual risk

Continued/Ongoing Process Verification (FDA Stage 3)

• How to maintain a state of control over the product lifecycle
• Implications of changes on supply chain

Tools That Enable Effective and Efficient Validation

• Quality risk management and risk register
• Statistical tools, e.g. control charts, process capability, DoE, multi-variate analysis

Change Management

This course is ideal for technical, engineering, and managerial personnel responsible for facility/utility/equipment qualification and process validation, quality unit staff, and regulators.

Course tutors will be selected from the following:

• Nick Martin
• Chester French
• Matt Peplowski