Prepared by:
Approved by:ASEAN TMHS GMP Task Force
Endorsed by:ASEAN TMHS Product Working Group
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplements (TM/HS)
30 November 2016
CHAPTER 4 – SANITATION AND HYGIENE
Thailand
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
ACKNOWLEDGEMENTWe would like to thank the following review team for their
input to this training module.
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Muhammad Lukmani Ibrahim Chair of ASEAN GMP
TF
Quitevis, Ludivina FamaCo-Chair of ASEAN
GMP TF
Mega Valentine ASEAN Secretariat
Hasmilawaty Mohammad Taib Brunei Darussalam
Jamilah Metusin Brunei Darussalam
Hean Kimseat Cambodia
Som Samnang Cambodia
Kristiana Haryati Indonesia
Widiastuti Adiputra Indonesia
Bounleuane Douangdeuane Lao PDR
Solivanh Sengchanh Lao PDR
Sivong Sengaloundeth Lao PDR
Mohd Nasrul Mohamad Noor Malaysia
Sharifah Mastura Ahmad Fuad Malaysia
Thiri Kyaw Soe Myanmar
Wah Wah Aung Myanmar
Mary Angeline V. Francisco Philippines
Ms. Rochel Averion Francisco Philippines
Ong Hai Ann, Terrance Singapore
Pinpong Intarapanich Thailand
Thida Thaveerit Thailand
Lam Quoc Hung Vietnam
Luu Duc Du Vietnam
Mak Sum Shing, Andrew AAHSA
Tamotsu Iwai AAHSA
Robles, Frances Evelyn AATMI
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
OUTLINE
• Principle
• Personnel:
–Practice of Good Personal Hygiene
– Training of Good Personal Hygiene
• Premises
• Equipment and Utensils
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ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
PRINCIPLE
• A high level of sanitation and hygiene shall be practised inevery aspect of the manufacturing of TM/HS.
• The scope of sanitation and hygiene covers personnel,premises, equipment and utensils; in fact, anything thatcould become a source of contamination to the product.
• All employees shall be instructed and encouraged toreport to their immediate supervisor any conditions(plant, equipment or personnel) that they consider mayadversely affect the quality of products.
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ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Taking necessary precautions to protect components,TM/HS products and contact surfaces against the
contamination of:
• micro-organisms
• filth
• other extraneous materials
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PRINCIPLE
MODULE CHAPTER 4 – Sanitation and Hygiene 6
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Hygienic control on manufacturing processes,including personnel, premises, equipment andhandling of materials [from starting materials tofinished products].
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SANITATION
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Conditions and practices that help to maintainhealth and prevent the spread of disease
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HYGIENE
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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MODULE CHAPTER 4 – Sanitation and Hygiene
PERSONNEL
MODULE CHAPTER 4 – Sanitation and Hygiene 10
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
All personnel, prior to employment shall undergo healthexaminations. During the course of their employment theyshall also routinely undergo health examinations which shallinclude relevant examinations appropriate to the tasks thatthey are required to perform.
E.g. General health examination for all personnel
Eye examination for all personnel
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Procedure and record of personnel hygiene foremployees who perform manufacturing processesshould be available :
Annex 1 - SOP on Personal Hygiene
Annex 2 - Record Daily Inspection on Personal Hygiene
Annex 3 - General Health Examination
Annex 4 - Employee Illness Report Form
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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All personnel shall practice good personal hygiene.They shall be trained in the practices of personalhygiene. High level of personal hygiene shall beobserved by all those concerned with manufacturingprocesses.
Training
• Appropriate practices in personal hygiene
• Related written procedure and instructions
PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Personal HygieneRefers to cleanliness of a person’s body against
• Disease causing microorganisms
• Filth/dirt
• Extraneous materials
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Some examples to maintain Personal HygieneBath/Shower
Wash off dead skin cells and disease-causing microorganisms
Brush teethClear up the food residue which are source of microorganisms
Wear clean working clothes (uniform), gloves and footwearClothes, gloves and footwear can carry bacteria into the premises
Keep fingernails clean, trimmed and without polish No artificial nails (Polish or artificial nails can fall off)
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Any person shown at any time to have an apparent illness oropen lesions that may adversely affect the quality of productsshall not be allowed to handle raw materials, packagingmaterials, in-process materials, and finished products until thecondition is improved.
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Hand Washing
Direct contact shall be avoided between the operator's handsand , raw materials, intermediate or , bulk product.
Proper washing of hands and wearing of gloves shall be used ifcontact with hands is unavoidable.
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Hand Washing
Ensure that the hands arewashed properly beforeentering the production areasand rewashed or have thegloves changed whencontaminated
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Hand Washing• After using the toilet
• After touching bare body parts (skin)
• After coughing, sneezing, using a handkerchief or tissue
• After consuming food , drinking, smoking
• Before entering/returning to manufacturing areas
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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PERSONNEL
How to wash your hand
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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PERSONNEL
Use of GlovesGloves are used to protect materials andproducts from directly contacting barehands
Hands should be washed properlyand thoroughly before puttinggloves on
Minor cuts, scrapes, etc. should becovered with an approved bandageprior to putting on gloves
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Protective garmentsAssure protection of the product from contamination as well asthe safety of the personnel, appropriate protective garmentsshall be worn. Soiled uniforms shall be stored in closedcontainers until properly laundered.
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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PERSONNEL
Appropriate protective garment (uniform)
Ensure that clean uniform, footwear and hair covers are sufficiently provided to all production employees
Ensure that clean,dedicated uniform,footwear and haircovers are wornwhen entering themanufacturing area.
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Appropriate protective garment (uniform)To prevent hair from falling into materials, products andequipment, hair net and effective hair restraints must be worn.
– Hair net should be of appropriate quality to contain hair and be replacedwhen damaged or worn out
– All hair must be tucked inside the net
– The net should be sufficiently large to cover both ears
– Wear beard net (where applicable)
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MODULE CHAPTER 4 – Sanitation and Hygiene
PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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Bouffant Cap/ Hair Net
GlovesShoe CoverProduction Coverall
Appropriate protective garment (uniform)
PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Only authorised personnel shall beallowed to enter production areas.
Visitors or untrained personnel shall,preferably, not be taken into theproduction and quality control areas.
If this is unavoidable, they shall begiven information in advance,particularly about personal hygieneand the prescribed protectiveclothing. They shall be closelysupervised.
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Smoking, eating, drinking and chewing or keeping of plants, food,drink, smoking materials and personal medicines shall berestricted to specific areas and not permitted in production,laboratory, storage or other areas where they might adverselyinfluence product quality.
A separate dedicated area for eating shall be provided outside theproduction area.
Personnel medicines should be stored in the individual locker toavoid false and/or mixed up during production process
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
The wearing of makeup, wrist watches and jewelry shall beprohibited in the production area.
However for jewelry or objects that cannot be removed; it mustbe covered by material (e.g. gloves) that is maintained in anintact, clean and sanitary condition.
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PERSONNEL
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Sanitation of Premises
Premises used for themanufacturing of products shall beof suitable design and constructionso as to facilitate good sanitation.
Ensure that the premise is neat andclean and is free of puddled water.
Floorings of the equipmentwashing rooms could be sloped toallow draining of water
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PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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Hand washing and well ventilated toilet facilities and changingrooms shall be provided for personnel at suitable locations.
PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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Suitable locker facilities shall be provided at appropriate locationsfor the storage of employees clothing and personal property.
PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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The preparation, storage and consumption of food andbeverages shall be restricted to specific areas, such asmeal rooms and canteen.
Facilities in such rooms must meet sanitary standards.
Meal rooms and canteen rooms shall not have directaccess to controlled areas (e.g. production area andareas use to store materials used for production andfinished products).
PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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Waste material shall not be allowed to accumulate.It shall be collected in suitable receptacles forremoval to collection points outside the buildingsand disposed of safely and in a sanitary manner atregular and frequent intervals.
Ensure that there are no harborages and breedingareas for pests at the site
Ensure that properly closed areas are used forstorage of waste materials
PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Rodenticide, insecticides, fumigating agents and sanitizingmaterials used must not contaminate equipment, raw materials,packaging materials, in-process materials or finished products.There shall be a pest control programme, documents such aslayout, trending and expectations.
Contract agreements shall be established,
where applicable.
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PREMISES
Annex 5 - Sample of Pest Control Inspection RecordAnnex 6 - Sample of Pest Control Monitoring RecordAnnex 7 - Sample SOP on Pest Control
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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Equipment drying
Dirty equipment IN
Equipment
washing
Dry, clean
equipment
storage
Corridor
Step over
WFI Rinse
HPW
wash and
WFI Rinse
Potable water
HPW Wash
WFI RinsePotable
water
Potable
water Material
airlock
Dispensing
1st PAL
2nd
PAL
Change
room
Dispensed
material
storage
Dispensing tools wash
HPW, and WFI
Material
storage
Quarantine
TMHS Solid dosage
storage
Released Semi finished
TMHS Solid dosage
storage
TMHS
Semi finished
Product exit
FBD
Mill
Technical area
No filtered air
Granulation room
Potable water
HPW
wash
Film Coater
Coating solution
Potable water
HPW
Granulation Buffer roomCoating buffer
Compression buffer
Compression
PREMISES
1
2 3 4
5
= Bait stations First rotation
= Bait stations Second rotation
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2 3 4
= electric insect eradicators
Layout of pest and insect control in Processing Area
= Mechanical traps
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
sampling room
weighing roomEmergency Door
Emergency Door
Starting materials
Emergency Door
Packaging materials
Warehouse
finished products
Quarantine
Receiving area
MODULE CHAPTER 4 –Sanitation and Hygiene
1
2
3
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= Bait stations First rotation
= Bait stationsSecond rotation
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1
2 3
4
= electric insect eradicators = Mechanical traps
Layout of pest and insect control in Warehouse
PREMISES
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ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
There shall be written procedures assigning responsibility forsanitation and describing cleaning schedules, methods,equipment, materials to be used and facilities to be cleaned insufficient detail. Such written procedures shall be followed andthe result shall be documented.
Annex 8 - SOP on Cleaning of Equipment and Accessories
Annex 9 - Cleaning Schedule Form
Annex 10 - Cleaning Record Form
Annex 11 - Cleaning Inspection Record
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PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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MODULE CHAPTER 4 – Sanitation and Hygiene
Pets are not allowed within the vicinity of themanufacturing plant.
PREMISES
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Equipment and utensils shall be cleaned bothinside and outside after use according toestablished procedures. Cleaned equipmentshall be kept or stored in a clean conditionand identified with the status of cleaning, andchecked for cleanliness prior to each use.
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Vacuum or wet cleaning methods are preferred. Compressed airand brushes shall be used with care or avoided if possible, asthey increase the risk of product contamination
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Compressed air
EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Cleaning agents, washing and cleaning equipment shall notbe a source of contamination.
The choice of cleaning method and agents shall be carefullyconsidered and justified.
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Adequate space, preferably separated from processing areas,shall be provided for cleaning and storing mobile equipment andutensils including the storage of cleaning materials.
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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EQUIPMENT AND UTENSILS
A separate room maybe needed for storingclean, idle equipmentwhich should be keptdry at all times.
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Written procedures shall be established and followed forcleaning and sanitising of equipment, utensils andcontainers used in the manufacture of health supplements.
Please see Annex 9 on Cleaning Schedule
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
These procedures shall be prepared to prevent equipmentcontamination by cleaning or sanitising agents and shall at leastinclude the following:
1. Responsibility for cleaning
2. Cleaning schedule
3. Cleaning methods
4. Equipment and materials used in cleaning operations
5. Methods of disassembling and reassembling equipment
6. Removal of previous batch identification
7. Protection of clean equipment and utensils from contamination prior to use
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
Records of cleaning, includingthe appropriate sanitising andinspection conducted prior touse shall be maintained.
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EQUIPMENT AND UTENSILS
ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
REFERENCES
1. ASEAN Guidelines on Good Manufacturing Practice for Traditional Medicines.
2. ASEAN Guidelines on Good Manufacturing Practice for Health Supplements.
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ASEAN Guidelines on GMP for Traditional Medicines / Health Supplement 2015Chapter 4 - Sanitation and Hygiene
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THANK YOU!
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