sanitation and hygiene - asean

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


OUTLINE

• Principle

• Personnel:

–Practice of Good Personal Hygiene

– Training of Good Personal Hygiene

• Premises

• Equipment and Utensils

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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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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


Hygienic control on manufacturing processes,including personnel, premises, equipment andhandling of materials [from starting materials tofinished products].

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SANITATION


Conditions and practices that help to maintainhealth and prevent the spread of disease

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HYGIENE


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MODULE CHAPTER 4 – Sanitation and Hygiene

PERSONNEL

MODULE CHAPTER 4 – Sanitation and Hygiene 10


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


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


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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


Personal HygieneRefers to cleanliness of a person’s body against

• Disease causing microorganisms

• Filth/dirt

• Extraneous materials

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PERSONNEL


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


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


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


Hand Washing

Ensure that the hands arewashed properly beforeentering the production areasand rewashed or have thegloves changed whencontaminated

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PERSONNEL


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


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PERSONNEL

How to wash your hand


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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


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


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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.


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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PERSONNEL


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Bouffant Cap/ Hair Net

GlovesShoe CoverProduction Coverall

Appropriate protective garment (uniform)

PERSONNEL


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


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


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


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


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Hand washing and well ventilated toilet facilities and changingrooms shall be provided for personnel at suitable locations.

PREMISES


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Suitable locker facilities shall be provided at appropriate locationsfor the storage of employees clothing and personal property.

PREMISES


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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


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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


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


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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


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

5

1

2 3

4

= electric insect eradicators = Mechanical traps

Layout of pest and insect control in Warehouse

PREMISES

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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


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Pets are not allowed within the vicinity of themanufacturing plant.

PREMISES


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


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



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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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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A separate room maybe needed for storingclean, idle equipmentwhich should be keptdry at all times.


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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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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Records of cleaning, includingthe appropriate sanitising andinspection conducted prior touse shall be maintained.

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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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THANK YOU!

ONE VISION, ONE IDENTITY, ONE COMMUNITY

sanitation and hygiene - asean

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