GEN-034

Gowning Procedure
This product was funded by a grant awarded under the Presidents
High Growth Job Training Initiative as implemented by the U.S.
Department of Labors Employment & Training Administration. The
information contained in this product was created by a grantee
organization and does not necessarily reflect the official position of
the U.S. Department of Labor. All references to non-governmental
companies or organizations, their services, products, or resources
are offered for informational purposes and should not be construed
as an endorsement by the Department of Labor. This product is
copyrighted by the institution that created it and is intended for
individual organizational, non-commercial use only.
Learning Objectives
Establish gowning requirements for those
areas identified as GMP Zones (GMP
areas designated by gowning requirement,
environmental controls & frequency of
cleaning).
Additional personal protective equipment or
cleaning requirements may be required for
certain products.
Responsibilities
All employees to follow this procedure
Quality Assurance & Management
responsible to ensure personnel follow this
procedure.
Employees are to report to their supervisor
any need for uniform repair or
replacement.
Personnel hosting visitors must comply
with this procedure.

References
GEN-002 Personnel Responsibilities in
Plant Operations
SAF-008, Operation of the PAPR
(Powered Air Purifying Respiratory) Unit
SAF-001, General Safety
21 CFR 211.28 Personnel Responsibilities
Procedure
GMP Zones
Detail the dress/gowning requirements,
environmental controls and frequency of
cleaning.
Unidirectional flow to prevent contamination &
mix-ups.
Jewelry 7.2
In product processing areas
NO [w]Wrist bracelets, watches and
chains (necklaces)
NO loose fitting or long dangling
earrings (except one-piece earring fitting
under hairnets)
NO pins or other items
NO jewelry worn on uniform
One ring (band/small mounting) can
be worn under gloves.
Other Items 7.3
Not Permitted in Manufacturing &
Packaging areas
No heavy make-up
No false eyelashes
No artificial fingernails (unless covered by
gloves)
General Guidance 7.5
All special apparel must be worn properly
to ensure cleanliness & safety
No dress code for those wearing uniform
Non-uniformed employees dress to meet HR
dress requirements

Hygiene & Sanitation Practices
7.5.2
Always practice good practices
Wash hands with soap & warm water and dry
thoroughly after use of restroom or when
hands are soiled.
Avoid unsanitary practices/contamination
Scratching head
Wiping forehead
Fingers in nose, mouth, ears
Gowning Requirements 7.5.4
Applies to employees, visitors, &
contractors.
Hair Covering 7.5.5
Must be worn at all times in
manufacturing, packaging and warehouse.
Must cover as much hair as possible
Long hair tucked
Facial hair covered with beard covers
Applies to all employees and visitors
Safety Glasses 7.5.6
Must be worn by all employees &
visitors entering
Designated Laboratory Areas
Compression/Blending Manufacturing
Areas
Designated packaging areas
(Dispensing)
Equipment Washrooms
Note: Must also be worn while cleaning
agents/chemicals or work with
potential to cause eye injury
Uniform/Lab Coat 7.5.7
Adequate number issued to ensure
cleanliness
All buttons secured except collar
Shirts tucked in trousers and rolled down &
cuffs snapped.
Dedicated storage areas are provided
NOT worn outside facilities except
Emergency evacuation
Maintenance personnel traveling between
facilities

Uniform/Lab Coat 7.5.9
NOTE:
Office staff, management when traveling
between buildings Carry lab coats over
forearm. Don when enter classified areas.
Employees in plant uniforms must wear lab
coats when traveling between buildings.
Remove prior to entering classified area
Hair net, beard cover, lab coats and
gloves must be removed prior to leaving
GMP zones.
General Information 7.5.10
No personal clothing (including
shoes) in Manufacturing/Packaging
areas unless covered by lab coat
(shoe covers).
Applies to
personnel/visitors/contractors
Soiled uniforms placed in designated
areas for cleaning.
Employees report need for repair or
replacement of uniform
Shoes 7.15.13
All employees (Mfrg, Pkg, Whse, Lab) if not
wearing safety shoes must wear flat-heels,
closed toe (no sandals).
Keep clean, [l]Laced
Plant shoes not taken home
Shoe covers required on non-plant shoes
specified areas Liquid Capsule
Approved Safety Shoes- required by Whse/Mtrl
Hndlr/Maint/Custodial personnel
Gowning Requirements 7.6
Employees
Clock-in
Sanitize hands
Security Check point
No [f]Food in gowning areas or in GMP
zones.
Store food in refrigerators before going to
gowning areas
DO NOT CARRY FOOD IN WHSE

Gowning Area Requirements
7.6.4
Warehouse, 1, 2, WIP Areas
Uniform & Hair net
Remove and discard hair net when leaving to
unclassified area
Warehouse
Uniform, Hair net and beard cover
Remove and discard hair net/beard covers
when leaving to unclassified area
Gowning Area Requirements
7.6.4.4
Manufacturing 1
Uniform, hair net, plant shoes/shoe
covers and beard covers.
Lab coat if not wearing uniform
Clean gloves appropriate for tasks
Remove and discard gloves before
entering gowning area.
Remove lab coat, hair net and beard
cover (change uniform or de-dust)
Exception for Maintenance personnel
Gowning Area Requirements
7.6.4.5
Packaging 2 & 3
Uniform, hair net, and beard cover
(lab coat when no uniform)
Direct contact with product and
packaging components require
appropriate gloves.
Remove and discard gloves before
entering gowning area
Remove lab coat, hair net and beard
cover before leaving gowning area.
Uniforms changed or de-dusted.
Gowning Area Requirements
7.7
Special Gowning Areas (Hormones
Use Gowning airlock for controlled
manufacturing suite areas
NO Food or drink
Enter airlock, close door and confirm door to
manufacturing area is closed
Don protective suit (Tyvek) over uniform or loose
clothes
Belt mounted PAPR & head hood
PAPR Requirements 7.7.6
Complete respirator fit training and
documentation
Complete medical questionnaire
Treatment authorization, Pass exam for
respiratory clearance.
Two employees gowning (Buddy System)
Assist and confirm proper operation prior to
entering area
PAPR Requirements 7.7.7
Prior to leaving the manufacturing area
Employees brush off each other (or walk thru blow
down unit) to remove excess product material.
Remove and discard gloves before leaving gowning
airlocks
Confirm entrance & exit doors are closed
Remove PAPR system and tyvek suit
Shower, dispose of suit if end of shift
No visitors in controlled manufacturing areas without
approval and proper training