Personal hygiene Source of Contamination and control GMP Requirement /Guideline Procedures & Records Protective Clothing & gowning Health Examination Hand wash – How and when Training & Practice by Dr. A. Amsavel

1. Personal Hygiene In
Pharmaceutical Industry
Dr. A. Amsavel, M.Sc., B.Ed., Ph.D.,

2. An Over View
 Personal hygiene
 Source of Contamination and control
 GMP Requirement /Guideline
 Procedures & Records
 Protective Clothing & gowning
 Health Examination
 Hand wash – How and when
 Training & Practice

3. Hygiene meaning
 Collins Dictionary:
Hygiene is the practice of keeping yourself and your
surroundings clean, especially in order
to prevent illness or the spread of diseases.
 Cambridge Dictionary:
The degree to which people keep themselves
or their environment clean, especially to prevent
disease
What will causes the disease??

4. Definition
Contamination:
 The undesired introduction of impurities of a
chemical or microbiological nature, or of foreign
matter, into or onto a raw material, intermediate, or
API during production, sampling, packaging or
repackaging, storage or transport.
Cross-Contamination
 Contamination of a material or product with another
material or product.

5. Contamination Control
API as well as drug product manufacturing area, specifically clean room has
to be designed and maintained to prevent or minimize the contamination
from microorganisms , particulates etc
Objective is
 To ensue the Patient safety (contamination = risk to the patients)
 To ensure quality, purity, safety and efficacy of the product
 To comply GMP and Regulatory Requirement
 Minimize the product defective / failure
 Quality of product should be built into design and systems during manufacturing,
NOT BY TESTING
Set the systems, practices and procedures to eliminate or minimise the introduction
of contaminant into a product / process.
Microorganism: Bacteria, Yeast, Fungi, mold, pathogens etc
Particulates: Particles other than product, ie. Fiber, filth, fragments, hair, metal, plastics etc.

6. Sources & Control of Contamination
# Source Possibility of
contamination
Reduce / Elimination of
contamination
1 Personnel Improper gowning, not washing
hands properly,
Lack of cleanliness, Working
with illness, etc
Hygiene procedure, Gowning,
hand washing, use of PPEs,
Training, Practice,
2 Environ-
ment
Lack of design, control &
monitoring. Open and access to
bird and vermin
Facility , HVAC design, Clean
room, Air filtration, Cleaning,
Operation and Maintenance
3 Equipment Unsuitable equipment, Lack of
cleaning/not easy to clean
Cleaning, Maintenance
4 Material Improper control of material.
Receipt, storage and transfer,
etc
Restriction, de-dust/ de-
contamination

7. Good Manufacturing Practice
Q7 Good Manufacturing Practice emphasis the requirements
to prevent contamination and cross-contamination by
practicing Good personnel hygiene and sanitization.
 It is mandatory and to ensure the compliance
 To ensue Product quality and avoid rejection
 To employee safety
 To avoid recall and complaints
 To avoid warning letter / import alert
 To avoid loss of business

8. GMP Requirements

9. ICH Q7: 3.2. Personnel Hygiene
 3.20 Personnel should practice good sanitation and health habits.
 3.21 Personnel should wear clean clothing suitable for the
manufacturing activity with which they are involved and this
clothing should be changed when appropriate. Additional
protective apparel, such as head, face, hand, and arm coverings,
should be worn when necessary, to protect intermediates and APIs
from contamination.
 3.22 Personnel should avoid direct contact with intermediates or
APIs.
 3.23 Smoking, eating, drinking, chewing and the storage of
food should be restricted to certain designated areas separate
from the manufacturing areas.

10. ICH Q7: 3.2. Personel Hygiene
 3.24 Personnel suffering from an infectious disease or having
open lesions on the exposed surface of the body should not
engage in activities that could result in compromising the quality
of APIs.
 Any person shown at any time (either by medical examination or
supervisory observation) to have an apparent illness or open
lesions should be excluded from activities where the health
condition could adversely affect the quality of the APIs until the
condition is corrected or qualified medical personnel determine
that the person's inclusion would not jeopardize the safety or
quality of the APIs.

11. 21CFR§ 211.28 Requirement
Personnel responsibilities.
a) Personnel engaged in the manufacture, processing, packing,
or holding of a drug product shall wear clean clothing
appropriate for the duties they perform. Protective apparel,
such as head, face, hand, and arm coverings, shall be
worn as necessary to protect drug products from
contamination.
b) Personnel shall practice good sanitation and health habits.
c) Only personnel authorized by supervisory personnel shall
enter those areas of the buildings and facilities designated
as limited-access areas.

12. 21CFR§ 211.28 Requirement
Personnel responsibilities.
d) Any person shown at any time (either by medical examination or
supervisory observation) to have an apparent illness or open
lesions that may adversely affect the safety or quality of drug
products shall be excluded from direct contact with
components, drug product containers, closures, in-process
materials, and drug products until the condition is corrected or
determined by competent medical personnel not to jeopardize
the safety or quality of drug products.
All personnel shall be instructed to report to supervisory
personnel any health conditions that may have an adverse effect
on drug products.

13. 21CFR§ 211.52 Requirement
 § 211.52 Washing and toilet facilities.
Adequate washing facilities shall be provided, including
hot and cold water, soap or detergent, air driers or
single-service towels, and clean toilet facilities easily
accessible to working areas.

14. Possibility of Contamination
 Personnel are both reservoirs and natural carrier of microorganisms.
 Contaminate the product while direct contact or unprotected.
 Contaminated clothing, touching other body parts or poor toilet
hygiene.
 Exposed skin sheds particles which have millions of microorganisms.
 Hair falling into the product, contaminate the product
 Finger nails and hands have germs
 Nose and mouth are natural reservoir of germs. Trap particles or
droplets from the nose and mouth by covering
 Street clothes that contain contaminants, organisms .
 Street shoes contain germs from the soil and dirt

15. Policy & Procedure
 Establish Policy or procedure for Practice good sanitation,
personal hygiene, health habits to cover all the aspect of
GMP requirement.
 Ensure SOP is followed strictly
 SOP for Entry and Exit of the clean rooms. Display the SOP
and picture for entry & exit at entrance
 Instruction to follow cleanliness and use of clean clothing,
use of disinfectant.
 Gowning, change over and clean room practices
 Cover hand wash how &when, bathing, nail cut, and etc.

16. Procedure & Records
 Smoking, Eating , Drinking and Chewing should NOT be allowed in
Production areas, laboratories and storage areas
 Personnel suffering from an infectious disease or having open lesions on
the exposed surface of the body should not engaged
 Visitors, other than production personal are also trained / instructed and
ensure that follows the procedures
 Supervisor has to ensure that employees are adhering to the personal hygiene policy
during all the times.
 Monitor daily or at appropriate interval that all are following the SOP
 Maintain relevant records; Eg.Training, Medical examination ,
periodic verification, illness record etc.

17. Instruction
 Use of PPEs, covers for head, face, hands and arms, proper
gowning to reduce the exposure and contamination. Eg dead
skin cells , hair fall, sweat, etc .
 Take daily bath , Cut nails and comb hair neatly
 Avoid direct contact with products
 Report the illness or open wound or symptoms
 Dot use Ornaments, Cosmetic, Watches, and other Chemicals
 Followed always; even no one is watching…
Procedure, Practice & Training

18. Protective Clothing
Protective Clothing for Product and personal safety
 Personnel should check the Cloth is clean, free from stain, soil, holes, loose
fibers before wear
 Wear always clean and covered clothing to prevent exposure
 Check for sterilizing and storing of clothing for use in sterile area
 Clothing should be changed in each shift /when appropriate.
 Avoid attachments to clothing or held in pockets (above the waist).
 Take precaution while transfer and storage of clean clothing ( covered /closed
bags or container)
 Store dirty cloths in closed containers separately until taken for laundry
 Laundry the cloths as per SOP in an appropriate facility.

19. Gowning Procedure
 Entry to the clean room should be via a system of
airlocks and a change room where operators are
required to don suitable clean-room garments.
 Eg .A one-piece jumpsuit, gathered at the wrists and
with a high neck.
 The headgear should be tucked into the neck of the suit.
 Trouser-bottoms should be tucked inside the footwear
and garment
 Alternately wear protective apparel to cover head
(gear), face, beard, hand, and arm coverings.
 Use dedicated shoe or cover with appropriate shoe
cover (booty), ensure it is clean
 Adjust as required by viewing the mirror.

20. Gowning Procedure
 Disinfect the hand before and after wearing gloves
with disinfectant solution
 Wrist-watches, and jewellery should not be worn in
clean areas or cover properly.
 Excessive make-up, perfumes, colognes, fake
fingernails, and hair extensions should be
prohibited.
 Use appropriate apparels in other areas chemical
process. Warehouse, and Laboratory

21. Illness and Lesion
 Personal with any infectious diseases or communicable
diseases shall not be allowed in the manufacturing.
 Report any flu-like symptoms, fever, diarrhea, sore throat,
constant sneezing, etc
 Personal with above symptoms will be sent back or re-
assigned to non-manufacturing area.
 Personal shall report open wound, any lesions on the hand,
wrist, or any exposed body part and should not be allowed to
handle materials are manufacturing area until the condition is
improved

22. Health Examinations
 All personnel including contract employees, directly involved
in handling of product / manufacturing shall be examined
their Health before joining.
 Perform health exam during employment periodically as per
requirement ie once in six months or yearly
 Eye check up for those, involve visual inspection and all QC
personal
 Perform health examination after long illness
 Instruction and encouragement to report to the Supervisors

23. Hand Wash
 Procedure / Clear Instruction for Hand wash.
 Pictorial display for Hand washing, and drying of hands
 Use Soap preferably antibacterial to clean the hands

24. Hand Wash
 When Hand Wash must be performed;
 Before commencing work.
 Before wearing disposable gloves.
 Between performing different task.
 After using the toilet and returning to work
 After smoking, eating or drinking.
 After handling contaminated item or working unsanitary activities like
removing garbage, wiping sink, utensils, etc.
 Specifically ascetic area - after touching face, nose, mouth, skin, hair
or other exposed body parts. After sneezing, coughing or nose
blowing , hand must be washed

25. Rest Room & Bathing
 Rest and refreshment areas should be separate from Manufacturing and
Control areas
 Rest (Toilet) area shall be away from clean room
 Toilet shall be maintained in hygiene condition ie cleaning periodically
 Facility for bathing / Shower with hot water based on the requirement and
nature of products handled
 Ensure the necessary arrangement like soap, hand drier or single use towel
or disposal paper napkin
 Endure decontaminate of garments as applicable

26. Cleaning & Waste Disposal
 High level of sanitation and hygiene practiced in every aspect
of manufacturing.
 Cleaning of Premises, Equipment and apparatus/ utensils
 Area / materials & potential sources of cross-contamination
 Production materials and containers
 Materials used for cleaning and disinfection
 Garbage / trash shall be kept in closed container and carefully
removed and disposed.

27. Training – Personnel Hygiene
 As per data, 70 % of the failure in sanitation and hygiene attributed to the lack
of orientation and inadequate Training.
 Personnel should be trained to minimizes the possibility of contamination and
contaminant being generated or transferred or deposited on or into the
product.
 Training on the following areas, but not limited to ;
 GMP, Procedure, Processes and Operation, cleaning of area & equipment
 Clean room practices , gowning, aseptic technique, health, Safety risk, and
relevant intervention procedures.
 Explain the causes and consequences due to poor personal Hygiene,
 Evaluate /Assess the effectiveness of training
 Validation /verification and monitoring as required. eg bio-burden In gown,
finger, area, equipment etc

28. Design the Facility
 Design Protection from insects, birds, vermin and weather
 Drains should prevent back flow
 Design the walls, floors, ceilings, ledges, drains, air supply, dust extraction
meets the GMP requirement and easy to clean and maintained.
 Prevention of build-up of dirt and dust to avoid unnecessary risks of
contamination
 Ventilation systems and airlocks appropriately designed
 Storage of cleaning equipment's and utensils separately after cleaning
 Ensure all the areas from receipt of raw materials, packaging material
storage , production, sampling and testing etc

29. References
 21 CFR Part 820 Quality System Regulation, US FDA – current
version.
 21 CFR Part 211 Current Good Manufacturing Practice for Finished
Pharmaceuticals, US FDA – current version.
 ICH Q7 Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients, ICH Harmonised Tripartite Guideline, 10
November 2000.
 ASEAN Guidelines on GMP for Traditional Medicines / Health
Supplements

30. Thank You