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Obj tiObjectives

P id i f th HVAC� Provide an overview of the new HVAC GPG

S t t ti h t i d i ’t i th� Set expectations on what is and isn’t in the GPG

� Review some key concepts from the guide� Review some key concepts from the guide

� Provide selected examples from the guide.

� Discuss what’s in the 3 day HVAC class

� Bust some Myths

2

Bust some Myths

Q ti #1Question #1

� Who are you?

� Quality Control / Quality Assurance

� Manufacturing Operations

� Maintenance / Facilities /Utility

Operations

� Commissioning / Qualification/ Validation

� Engineering

� Project Management

3

Q ti #2Question #2

� Why are you here?

� Learn what’s unique to HVAC for GMP’s

� Better understand what engineers are doing

� Explore new resource for compliance

� Looking for sustainability ideas

� Boss ordered me to come

4

Q ti #3Question #3

� What do you know about HVAC?

� H, V… What?

� A little exposure, but not much

� Familiar, but not expert

� Experienced in HVAC, but not for

pharma

� My name is Willis Carrier, I invented

HVAC

5

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6

HVAC – Practical Guidance for GMP F ilitiFacilities

� What’s in the guide?

� Table of Contents

I t d ti d K C t� Introduction and Key Concepts

� Design process for HVAC

� Design Considerations (w/ Airflow Diagrams)� Design Considerations (w/ Airflow Diagrams)

� Design Review

� Equipment Spec, Install, Qualify and Operateq p p , , y p

� Documentation Requirements

� Appendices

7

Wh t’ i th id ?

A di

What’s in the guide?

� Appendices

� Fundamentals of HVAC

� HVAC Applications and Equipmentpp q p

� Psychometrics

� Science Based Risk Management

� Science and Risk Based Verification� Science and Risk Based Verification

� Economics and Sustainability

� Medical Devices

� Misc.

8

Wh t’ i th id ?What’s in the guide?

Th id tli t t d i h� The guide outlines structured, rigorous approach

to HVAC at all stages of it’s life

� Key to this approach is Understanding the ProductKey to this approach is Understanding the Product

and Process

� As is stressed in QBD, ICH Q9 and guides for

qualification the HVAC GPG highlights that processqualification, the HVAC GPG highlights that process

knowledge is paramount in cGMP.

� Rules of thumb – are given for conceptual use

M t d ff ti d i� May not produce an effective design.

� Will not produce an efficient design

� Are a way of going wrong with confidence

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Wh t’ NOT i th idWhat’s NOT in the guide

� Equipment Sizing

� Load Calculations

� Recommended Manufacturers

� Detailed Procedures and MOT

� Environmental Monitoring

� Offices and Vivariums

� Your Product Considerations

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