checklists

GMP Gowning Regimen
Classification	Description	Examples	Gowning	Remarks
G 0	Street clothes	Mechanical Room Electrical Room Storage Rooms Process Grey Space	No requirements	Access to unclassified and non-controlled spaces only
G 1	Plant Uniform	Warehouse Loading Dock Storage Rooms	Safety Shoes
G 2	Process Gown	Wash areas Secondary Packaging	Hairnet/ Beard Cover Labcoat over Plant Uniform Booties over plant shoes	may use dedicated shoes in lieu of booties
G 4	Process Gown	Media/ Buffer Prep Primary Processing Fermentation	Hairnet/ Beard Cover Process Gown over Plant Uniform Tyvek shoecovers over plant shoes Gloves
G 5	Process Gown- Aseptic	Aseptic Filling	Hairnet/ Beard Cover Process Gown with full headcover over Plant Uniform Tyvek shoecovers over plant shoes Goggles or face mask Gloves	No exposed skin Sterile gowning protocol includes pre-gowning
G 6	Process Gown- Laboratory	Quality Control Labs Microbiology Labs	Lab Coat over street clothes or Plant Uniform	Classified lab areas may require G 2 gowning
G 7	Special	TBD	TBD	TBD

In conjunction with other Tools and Checklists, let's start with a classification of the basic
spaces that are found in a typical GMP process facility...

The basic breakdown provides for Process space and Non-process space with individual
classifications suitable for most functions within a facility. These classification mostly are tied
to type of function, the environment most appropriate for that function, and ultimately, the cost of
the various space classifications.

The table below outlines the basics of the space classification system:

GMP Process Space
Classification	Description	Examples	Finishes	Remarks
Class 1	Support/ Utility	Mechanical Room Electrical Room Storage Rooms Process Grey Space	Floor- Sealed Concrete Walls- Epoxy Paint over CMU/ GWM/ Ext Siding Base- none Ceiling- Exposed Structure Other-	Upgrade floors to epoxy paint/ seamless epoxy May be rated walls
Class 2	Material Handling	Warehouse Loading Dock Storage Rooms	Floor- Walls- Base- Ceiling- Other-	Same as Class 1 space noted above Upgrades same as Class 1 noted above
Class 3-CNC	Process- CNC	Secondary Packaging	Floor- Sheet vinyl Walls- GWB w/ epoxy paint Base- Vinyl cove base Ceiling- AC tile Other- n/a
Class 3-D	Process- Class D	Media/ Buffer Prep Solid Dosage	Floor- Seamless epoxy Walls- GWB w/ epoxy paint Base- Epoxy cove base Ceiling- CR AC tile Other- n/a
Class 3-C	Process- Class C	Primary Processing Fermentation	Floor- Seamless epoxy Walls- GWB w/ epoxy paint Base- Epoxy cove base Ceiling- GWB w/ epoxy paint Other- n/a
Class 3-B	Process- Class B	Primary Processing Purification	Floor- Seamless epoxy Walls- GWB w/ epoxy paint Base- Epoxy cove base Ceiling- GWB w/ epoxy paint Other- n/a	Pre-engineered ceiling system for laminar flow areas
Class 3-A	Process- Class A	Aseptic Processing Lyo Loading/ Unloading	Floor- Seamless epoxy Walls- GWB w/ high- build epoxy paint Base- Epoxy cove base Ceiling- GWB w/ epoxy paint Other- stainless steel/ acrylic doors at air walls	Pre-engineered ceiling system for laminar flow areas Maybe use pre-engineered modular wall system
Class 4	Laboratory	Quality Control Lab Microbiology Lab	Floor- Sheet vinyl Walls- GWB w/ epoxy paint Base- Vinyl cove base Ceiling- CR AC tile Other- n/a
Class 5	Environmental Chamber	Cold Room Freezer Room Warm Room	Floor- M panel/ Sheet vinyl Walls- M panel Base- none Ceiling- eggcrate/ M panel Other- n/aOther- n/a	Upgrade floor to seamless epoxy
Class 6	Other/ Specialty	TBD	Floor- Walls- Ceiling- Other-

GMP HVAC Classifications
FDA Classification	ISO Classification	EU Classification	Description	Remarks
Unclassified	N/A	N/A	General Access Unrestricted
Unclassified	N/A	N/A	Grey Space Mechanical Access
Controlled Non- Classified	N/A	Grade D	Return Corridor Equipment Wash
Class 100,000	Class 8	Grade C	Process Areas Material Prep Areas
Class 10,000	Class 7	Grade B	Inoculum Lab Final Processing
Class 100	Class 5	Grade A	Bulk Filling Open Process Steps
HEPA Filtered UnidirectionalAirflow	N/A	N/A	Equipment Cool-down

Non-process Space
Classification	Description	Examples	Finishes	Remarks