Personal Hygien in Pharma industry

1. Personal Hygiene

2. Agenda
•Why Personal Hygiene?
•Things to do before you get to work
•Things to do when you start your work
•Hand washing procedure
•Use of Hand Sanitizer
•Use of protective items
•General Precautions
•Lunchroom/Cafeteria
•Expectation of FDA

3. Why Personal Hygiene?
•The manufacturing of medicinal
products relies upon people.
•All personnel should receive initial and
continuing training, including hygiene
instructions, relevant to their needs.

4. Before you get to work
•Take a shower
–Wash off dead skin and bacteria
•Put on clean clothes and footwear
–Clothes and footwear can carry
–bacteria into the plant
•Keep fingernails clean, trimmed and

5. Before you get to work (1)
•without polish / no artificial nails
–Polish or artificial nails can fall off
•Place outside clothes/ footwear in locker.
•Put lunches (food) in designated places.

6. Before you get to work(2)
•Put on clean plant uniforms and footwear for
use in plant only.
•Wash hands with soap/soap solution before entering to
the plant.
•Don’t wear watches or jewelry.
•They carry soil and bacteria.
•Use clean footwear.
•Footwear can bring in contamination from the outside.

7. Before you get to work(3)
•Empty pockets above waist
•Sew pockets Or Remove, if possible
•Pens and other objects can fall out when you bend over
•These items are often physical hazards
•They also carry bacteria

8. Before you get to work(4)
• You should wash your hands:
• Before beginning a work shift.
• After using restrooms.
• After eating, drinking or taking a break.
• After touching bare body parts (skin, hair).
• After coughing, sneezing, using a handkerchief or tissue.
• After handling toxic chemicals.
• After taking out trash.
• After handling dirty linens.
• At the end of task.

9. Hand washingprocedure

10. Hand Sanitizer
•Use approved hand sanitizer in
recommended quantity when leaving
washroom.

11. Why wear hairnets?
•HAIR NETS:
•Hair gets washed less frequently than other
parts of the body.
•Hair follicles produce oil
•The oil attracts dust containing bacteria
•Hair falls out periodically
•If the hair drops into product or onto product
contact surfaces, it will contaminate the drug
product.

12. Why wear hairnets/ beard mask?
•HAIR NETS AND BEARDNETS:
•Hair nets and beard nets protect drug
products from contamination
•All hair must be tucked in nets.

13. Why wear handgloves?
•HAND GLOVES:
•Gloves are used to protect drug product from
your hands
Cuts, etc. should be covered with an approved bandage
first.
Hands should be washed thoroughly before putting on
gloves
•Inspect gloves before wearing for pinhole leaks or
cuts.

14. General Precautions
• Don’t take food, personal medication or drink in
manufacturing, processing, storage, and packaging
areas.
• No use of gum or tobacco in product handling areas.
• Don’t taste the drug product.
• Injuries, infections, disease must be reported to
supervisor.
• Communicable disease: Pathogens transmitted by
one person to another – may be by touch / through
food / by aerosols

15. General Precautions (1)
•Don’t use plant uniform to clean hands.
•Never sneeze into air.
•Don’t chew gum/tobacco.
•Display signs, where appropriate.
•Change plant uniform at specified frequency
OR as and when it get dirty.
•Every staff must undergo for Health Check‐up at the
time of joining and thereafter once a year or as per
job requirement.

16. Lunchroom/Cafeteria
•Eat only in the lunchroom/Cafeteria
–Not in the processing area
•Store your lunch in designated area
–Not in lockers
•Don’t leave garbage lying around
–it attracts rodents and insects.

17. Visitors
•Entryof unauthorized persons must
be restricted.
•Visitors/Investigators/Auditors should always
be escorted.
•Explain entry and exist policies/SOPsto
visitors before they enter into the plant.

18. Expectation of Health Authorities

19. Personal Hygiene
•Establish detail hygiene program as per the
requirement including procedure relating to the
health, hygiene practices and clothing of
personnel.
•These procedure should be understood and
followed strictly by every person whose duties
take him into the production and control areas.
•Personnel should be instructed to use the hand‐
washing facilities.

20. Personal Hygiene (1)
• Personnel 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.
• Personnel shall practice good sanitization and health
habits.
• All Personnel should receive medical examination upon
recruitment.
• After the medical examination at the time of joining the
organization, re‐examination should be carried out Once a
Year OR as and when necessary as per work and personal
health requirement.

21. PersonnelHygiene (2)
• Only personnel authorized by supervisory personnel shall enter
those areas of the buildings and facilities designated as Limited‐
access areas.
• 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.

22. PersonalHygiene (3)
• As far as is practicable that no person affected by an
infectious disease, having an apparent illness, or having
open lesions on the exposed surface of the body that
may adversely affect the safety or quality of drug products
shall be excluded from direct contract 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.

23. PersonalHygiene (4)
•All personnel shall be instructed to report to
supervisory personnel any health conditions that
may have an adverse effect on drug products.
•Eating, drinking, chewing or smoking, or the storage
of food, drink, smoking materials or personal
medication in the production and storage areas
should be prohibited.

24. PersonnelHygiene (5)
• Visitors or Untrained personal should preferably,
not be taken into the production and quality control
areas. If this is unavoidable they should be given
information in advance, particularly about personal
hygiene and the prescribed protective clothing .
They should be closely supervised.

25. References
• 21 CFR Part 211 ‐ Current Good Manufacturing Practice For
Finished Pharmaceuticals.
• Rules and Guidance for Pharmaceuticals Manufacturers and
Distributors. MHRA. Chapter 2 EU Guidance for Good
Manufacturing Practice.
• World Health Organization, Technical Report Series, No. 908,
2003 Annex 4 Good Manufacturing Practices for
pharmaceutical products: main principles.
• Saudi Food & Drug Authority, Guide to Good Manufacturing
Practice for Medicinal Products, Version 2.1, Dt. 26.07.2011

26. Q & A