‫لجنة ارتباط المهندسين األردنيين في المنطقة الغربية‬

cGMP Guidelines/trends for HVAC Qualification

&Validation for Pharmaceutical/life-science Sterile and
non-Sterile Facilities.

Jeddah-KSA
19th April until the 21th April 2016
 ‫لجنة ارتباط المهندسين األردنيين في المنطقة الغربية‬

COURSE OVERVIEW

Do you feel that you have a gap between HVAC system related engineering works compared with
their effects on system/product Quality?! Do you need to avoid these gaps with minimal efforts?!

Do you feel that Qualification & Validation for HVAC system alone is enough to achieve ideal
Environmental Monitoring inside clean areas?!

Can you judge minimum Qualification & Validation scope for the HVAC system to maintain optimal
Environmental Monitoring along with minimum risk?! Or you must make it all?!

Do you ask yourself? What are the fundamentals of HVAC and meaningful abbreviation?

Did you hear about filter standards and specifications?!Do you need to know how/why these
filter are selected and categorized?!

Do you have a misleading for cGMP design (in term of HVAC components configuration) for
different pharmaceutical dosage forms as well as design of other life science spaces and
applications?!

Do you have any idea about difference between contamination and cross contamination as
concept, in addition to measures adopted to prevent that?!

Do you feel that you still need to implement more Qualification & Validation efforts with HVAC
system in order to satisfy yourself, your manager, your quality team and your internal/external
inspector that you have performed a complete trustful job?!

Can you work "in your firm" with one environmental standard, or you need to obey all?! And can
you harmonize these standards in one approach as a rule of thumb?!

What is the best Impact Assessment approach do you think that should be implemented in order
to and achieve an ideal/satisfying Qualification & Validation scope that in turn will be
harmonized with your Total Quality Management System (TQM)?!

Do you ask yourself about room classifications/Grades as well as relevant with regulatory
requirements?

Can you utilize and get benefit from other team efforts in conducting Qualification & Validation
activities?! Or you should only depend on yourself or your department as independent party?!

Do you face problems for assigning the responsibilities between contractor/supplier,

commissioners and yourself also for the execution of ideal qualification works?
 ‫لجنة ارتباط المهندسين األردنيين في المنطقة الغربية‬

WHO SHOULD ATTEND?

Pharmaceutical Qualification & Validation technicians, engineers, or managers

Infrastructure and maintenance technicians/engineers who are working with HVAC system
design or maintenance.
Process/Project engineers or managers who are responsible for HVAC system Design or
renovation.
Engineering Quality Assurance Specialists.
HVAC Calibration technicians / engineers.
Compliance and pharmacists from regulatory affair.
Quality Assurance specialists/engineers.
Microbiology lab supervisor who are involved with Environmental Monitoring reports.
Professionals from Service Organizations, contractor, designer and vendors who serve
pharmaceutical clients.
Regulatory/governmental personnel involved with pharmaceutical industries.
Internal / External Quality Auditors.

COURSE OBJECTIVES

 Understand all cGMP trends for HVAC system in both Pharmaceutical/life-science industries
including Sterile and Non-Sterile Facilities.
 Get in-depth understanding for GMP key aspects which are related to Heating Ventilation & Air
Conditioning (HVAC) System Design (Design versus facility functions) as well as cGMP
construction, operation and maintenance requirements.
 Have good idea about prevention of contamination/cross contamination between rooms/zones
with different functional activities.
 Understand the reason why his/her facility needs different types of HVAC systems/components
and recognizes all HVAC components and configurations including discussing intended cGMP
design purpose for each specific areas/zone.
 Have proper knowledge and considerations for all prerequisites that must be taken prior
Qualification & Validation of HVAC system.
 ‫لجنة ارتباط المهندسين األردنيين في المنطقة الغربية‬

 Have a good idea about filters standard and classification which are used in HVAC system itself
and inside classified facility in addition to have in deep ideas about differences between each
category and intended ideal use.
 Understand how all Qualification & Validation (Q&V) activities will interact together within the
same department or among different departments to achieve an ideal team-work spirits and
integrity.
 Have an idea about HVAC System lifecycle (installed in pharmaceutical/life-science Sterile &Non
sterile facility) starting from setting Level System Impact Assessment (SLIA),User Requirement
Specifications (URS), handling Design Qualification (DQ) ,Installation Qualification (IQ), Operation
Qualification (OQ) ,Performance Qualification(PQ) including protocols execution
,implementation and system development ,in addition to implement Requalification, Change
Control system and finally System Retirements.
 Understand the regulatory basics for HVAC Validation & Qualification in addition to Engineering
Requirements in pharmaceutical/life-science industry fields.
 Make evaluation for the acceptable and the best practices of HVAC Qualification & Validation
Activities within his/her firm.
 Be familiar with cGMP design related topics for European, US FDA and other international
requirements expectations and how they are reflected and implemented on field.
 Be able to harmonize the international regulation versus field work.
 Make evaluation for the good and bad practices for HVAC Validation Activities within his/her
firm.
 Be able to maintain the qualification status during lifecycle of HVAC system.
 Be familiar with room Classifications/Grades as addressed by regulatory and guidelines
requirements.
 Be familiar with proper personnel behaviors/constrains to be considered during working inside
classified clean room.
 Take idea about the cGMP related tests for cGMP critical areas which are served by HVAC
system.
 Be able to discuss and handle HVAC related Engineering quality attributes with inspectors from
both Local and International authorities.
 ‫لجنة ارتباط المهندسين األردنيين في المنطقة الغربية‬

COURSE OUTLINES

1.1. GMP Fundamentals of HVAC

1.2. Setting the Design Criteria based on process application and classifications for

sterile/non sterile Facilities

1.3. HVAC Qualification Protocols/Reports and relevant preparation guidelines,

including:

 System Level Impact Assessment

 User Requirement Specifications "URS"

 Design Qualification "DQ"

 Installation Qualification "IQ"

 Operation Qualification "OQ"

 Performance Qualification "PQ"

 Change control (CC)

 and Requalification

New ASTM-2500 verification approach will be discussed.

1.4. HVAC Requalification Management

1.5. Regulatory and Guidelines for "HVAC in pharmaceutical applications"

1.6. FDA inspection case studies (warning letters).

1.7. Workshop for Impact Assessment

Videos will be presented during the course.