Good Manufacturing Practices (GMP) Behavior

Requirements
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5

Purpose
In order to ensure that products are handled safely and effectively at all times
whilst within the company premises a Good Manufacturing Practices (GMP)
Behavior Requirements has been developed and implemented.
Scope
All employees and production processes in AcumeNexus.
Responsibility
All employees are responsible to ensure that Company Procedures are
followed correctly and that Good Manufacturing Practices (GMP) Behavior
Requirements is being complied with.
Definitions
N/A.
Procedure
5.1 Building and Facilities
5.1.1 Construction and Layout
5.1.1.1Buildings used in the manufacture or storage are of suitable
size, design and construction to permit unobstructed
placement of equipment, orderly storage of materials, sanitary
operation, and proper cleaning and maintenance.
5.1.1.2Floors, walls and ceilings are constructed of smooth, easily
cleanable surfaces and are kept clean and in good repair.
5.1.1.3All areas for storage of materials, packaging components; and
cleaning, manufacturing chemicals; and any flammable
materials are secured, properly enclosed and adequately
ventilated.
5.1.1.4All incoming service lines such as gas, electricity, hot and cold
water are adequately protected and clearly marked into
processing areas.
5.1.1.5Fixtures, ducts and pipes are installed in such a manner that
drip or condensate does not contaminate materials, utensils,
product contact surfaces of equipment, or finished products in
bulk.
5.1.1.6Lights are covered wherever they could shatter and impact on
product safety. Adequate lighting is provided for clear working
visibility.
5.1.1.7On site laboratories are segregated from production areas,
good laboratory practices are implemented in all on site
laboratories;
5.1.1.8The quality of water, air, compressed air that comes into
contact with product or packaging, that in itself does not
constitute an ingredient , is regularly monitored and presents
no risk to product safety or quality .
5.1.1.9Walls, floors and ceilings are impervious and easily cleaned.
5.1.1.10
Windows and doors linked to storage and production
areas are fitting and in good condition to control dust and
pest.
5.1.2 Environment
Site boundaries are to be clearly defined, fenced and secured if
considered appropriate, free of potential harborage for pests and
adequately drained.
5.1.3 Use of Signs
Appropriate signs will be placed throughout the premises wherever
it is considered to be advantageous to Product Safety or Staff
Safety. These signs should not be displayed in a manner that

creates a risk of product contamination.

5.1.4 Hand Washing
Detergent, sanitizer and hand drying facilities are available in
employee room and must be used in accordance with Procedure No
XXX.
5.1.5 Air Shower
Air shower is equipped to remove the foreign matters may stick on
the clothing between the entrance (employee or visitors) and the
production area.
5.1.6 Toilets
Toilets are to be well maintained and cleaned adequately,
positioned within walking distance of all food related activities and
not open directly to production facilities.
5.1.7 Pest Control
Pest capture or blocking facilities are available inside and around
the building in accordance with the pest control plan.
All doors, windows, ceilings are installed in such a manner as to be
free of gap or hole and maintained in good condition.
The pest control facilities are checked and maintained in
accordance with the proc No. XXX.
5.2 Equipment
5.2.1 Product Contact Equipment
Equipment in contact with Product is to be stored, cleaned and
maintained in such a manner as to prevent contamination.
5.2.2 Product Contact Surfaces
Product contact surfaces are to be in good condition, well
maintained and cleaned in such a manner as to prevent
contamination.
5.2.3 Pallets
Pallets are to be kept in good condition so as to prevent either
damage to product or foreign object contamination.
5.2.4 Preventive Maintenance
Equipment is maintained in accordance with Proc No XXX
Maintenance - Premises and Equipment.
5.2.5 Wood
The use of wood in all handling and processing areas is expressly
forbidden for all product contact surfaces.
5.2.6 Glass
No glass equipment, utensils, containers or test tubes are permitted
in Coolrooms, handling areas or processing areas. Glass
thermometers, containers or jars are not to be used in these areas.
5.3 Personnel
5.3.1 Clothing Policy
All staff members entering the production area should change and
wear the company uniforms, work shoes, hair nets and beard
covers.
5.3.2 Illness & Injuries
No staff member suffering from any illness, cut, abrasion or wound
is to commence work without clearance from management.
5.3.3 Hygiene and Sanitization
All staff members must be well presented and in clean uniform and
shoes. No jewelry is to be worn in production areas. All staff must
wash hands prior to handling product and after usage of toilet.
5.3.4 Smoking, Eating, Drinking & Cosmetics
Smoking is not permitted in all area in the factory including cool
rooms, handling areas, processing areas and chemical storage
areas. Eating and drinking is not permitted in the processing and
handling area. Cosmetics that could potentially compromise product
safety are not permitted.

5.3.5 Staff Movement

Care is to be taken by all staff and contractors when moving
throughout the building that cleaning and personal hygiene
procedures appropriate to the areas being left and entered are
complied with at all times.
5.3.6 Visitors & Contractors
All visitors and contractors must report to the office and must
comply with company Health and Hygiene procedure and Induction
Procedure. Sample taking is allowed only under the permit from the
management.
5.4 Storage
5.4.1 Raw Materials and Packaging materials
All raw materials and packaging materials are to be stored and
handled in a clean, dry area on pallets or appropriate shelving, in a
manner which prevents their mix-up, contamination with
microorganisms or other chemicals, or decomposition from
exposure to excessive heat, cold, sunlight or moisture. Open
packages to be kept covered wherever possible.
Containers of materials are labeled with respect to identity, lot
identification and control status.
Containers of materials should be clean and free of
damage/contamination.
Materials are sampled and tested or examined in conformance with
procedures prior to usage.
5.4.2 Finished Product
All finished products are to be stored in storage rooms, off the floor
in appropriate containers and at appropriate temperatures.
5.4.3 Chemicals
All hazardous, cleaning, pest control and testing chemicals are to be
stored away from product in designated areas.
5.4.4 Equipment
All product handling equipment and tools are to be stored off floors
when not in use.
5.4.5 Stock Rotation
Stock rotation is managed in accordance with Proc No XXX Storage
of Raw Materials Packaging and Chemicals and Proc No XXX Storage
of Finished Product.
5.4.6 Waste
All waste to be stored in designated waste storage areas.
5.5 Manufacturing
5.5.1 The equipment for processing, transfer and filling the utensils, and
the containers for holding raw and bulk materials are clean, in good
repair and in sanitary condition.
5.5.2 Only approved materials are used.
5.5.3 Samples are taken, as appropriate, during and/or after processing,
transfer or filling for testing for adequacy of mixing or other forms
of processing, absence of hazardous microorganisms or chemical
contaminants, and compliance with any other acceptance
specification.
5.5.4 Containers holding the materials are properly identified.
5.5.5 Major equipment, transfer lines, containers used for processing,
filling or holding are identified to indicate contents, batch
designation, control status and other pertinent information.
5.5.6 Product labels are examined for identity before labeling operations
to avoid mix-up.
5.5.7 The equipment for processing, holding, transferring of batch is
labeled regarding identity, batch identification and control status.
5.5.8 Packages of finished products bear permanent code marks.
5.5.9 Returned products are examined for deterioration or contamination.

5.5.10 Dropped Product

Dropped product or any product that has come into contact with
any unsanitized or contaminated surface shall be immediately
consigned to waste and is to be handled only by designated
personnel.
5.5.11 Dropped Tools & Utensils
No processing aids that have come into contact with the floor or any
other potentially contaminated surface shall be re used until they
have been re-cleaned in accordance with company cleaning
procedures.
5.5.12 Metal Detection
Not applicable in the company.
5.5.13 Rework
Rework is undertaken in accordance with Proc. No. XXX.
5.5.14 Waste Management
Industrial Waste is managed in accordance with Proc No XXX Waste
Management.
5.6 Laboratory Control
5.6.1 Raw materials, in-process samples and finished products are tested
or examined to verify their identity and determine their compliance
with specifications for physical properties and contaminations
5.6.2 Reserve samples of approved lots or batches of raw materials and
finished products are retained for the specified time period, are
stored under conditions that protect them from contamination or
deterioration, and are retested for continued compliance with
established acceptance specifications.
5.7 Records
5.7.1 Raw materials and primary packaging materials, documenting
disposition of rejected materials.
5.7.2 Manufacturing of batches, documenting the:
5.7.2.1Kinds, lots and quantities of material used.
5.7.2.2Processing, handling, transferring, holding.
5.7.2.3Sampling, controlling, adjusting and reworking.
5.7.2.4Code marks of batches and finished products.
5.7.3 Finished products, documenting sampling, individual laboratory
controls, test results and control status.
5.7.4 Distribution, documenting initial interstate shipment, code marks
and consignees.
5.8 Labeling
5.8.1 Basic requirements
5.8.1.1In addition to the name of the product, the statements of
identity, net contents, lot number, quantity, signature and
date.
5.8.1.2The labels should be applied on each packaging unit (carton,
plastic bin)
5.8.2 Color identification
5.8.2.1WHITE: indicates the information of materials, semi-products
and finished goods required in section 5.8.1.
5.8.2.2GREEN: indicates the status for materials, semi-products and
finished products which have been inspected and released by
QA, and allowed to move to the next process.
5.8.2.3YELLOW: indicates the status for materials, semi-products and
finished products which have been inspected by QA, and on
hold for further investigations, decisions, or actions. Items
with a yellow status cannot be moved to the next process.
5.8.2.4RED: indicates the status for materials, semi-products and
finished products which have been inspected by QA, and
decided to reject, scrap, or return. Items with RED status
cannot be moved to the next process.

5.8.2.5 RED work-in-process bins and baskets: only for rejected

product or material