cGMP guidelines/trends in HVAC Qualification/Validation for Pharmaceutical Sterile and non-Sterile Facilities/Projects

Engineering and Validation

Laboratory

Quality

Target Level

• Validation and Qualification scientists, Supervisor and Manager
• Infrastructure maintenance Technicians/Engineers who are working with the HVAC system, Design, Operation, Requalification, Monitoring, and Maintenance
• Process Engineers who are responsible for system innovation and monitoring
• Production supervisors or Manager
• Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
• Professionals from service organizations and vendors who serve pharmaceutical clients
• Quality Department (QA, QC (Microbiology), Regulatory Affairs and Compliance)
• Regulatory bodies involved in pharmaceutical industries.
• Internal/External Auditors and consultant

Description

Objectives and Expected Results

• Participants will understand all cGMP trends for the HVAC system installed in Pharmaceutical Sterile and non-Sterile Facilities.
• Participants will understand the reason behind your needs for different types of HVAC systems and recognize all the HVAC components and their purposes.
• Participants will have a good idea about prevention the contamination /cross-contamination concept between rooms/zones within their cross-functional activities
• Participants will understand how all HVAC components interact and Harmonized with other integrated systems.
• Participants will have a guideline to issue User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Execution in addition to developing HVAC system installed in different Sterile/Non-Sterile Pharmaceutical Facilities.
• Participants will get an in-depth understanding of the GMP key aspects of Heating Ventilation & Air Conditioning (HVAC) System Design (Designed in terms with the facility), construction, operation, and maintenance.
• Participants will have proper knowledge for the HVAC system component for each specific areas/use and its impact on the product quality
• Participants will have proper knowledge and considerations for all prerequisites that must be taken prior to the Qualification & Validation of the HVAC system.
• Participants will have a good idea about filters standard and classification which are used in the HVAC system itself and inside the classified facility, in addition, to have in deep ides about differences between each category and intended ideal use.
• Participants will understand how the Risk-Based approach for Qualification & Validation (Q&V) activities will be commenced and how this approach will let the team interact together within the same department or among different departments to achieve an ideal team-work spirit and integrity as well as deliver optimum qualification approach
• The participant will have an idea about the Pharmaceutical HVAC System lifecycle starting from setting User Requirement Specifications (URS’s) and up to Retirements (Complete Lifecycle approach)
• Participants will understand the regulatory and Guidelines requirements required for HVAC Qualification, in addition to relevant engineering requirements in both pharmaceutical/life-science industry fields that support product quality.
• Participants will be able to make an evaluation for the acceptable and the best practices of HVAC Qualification & Validation Activities within his/her firm.
• Participants will be familiar with room classifications/grades as addressed by regulatory and guidelines requirements.
• Participants will be familiar with cGMP design that comply with European, US FDA, and other international requirements & expectations, and how they are can be reflected and implemented on-site.
• Participants will be able to maintain the qualification status during the lifecycle of the HVAC system.
• Participants will be familiar with proper personnel behaviors/constraints to be considered during working inside a classified cleanroom
• The participant will take an idea of the cGMP related tests for cGMP critical areas which are served by the HVAC system

Others Training Materials

• Workshop, Sheets, and case studies paper will be conducted and implemented during training.
• Documentary Videos will be presented.

Target group