2. 1. DEFINITIONS
2. CURRENT FOOD MANUFACTURING
PRACTICE
3. PLANT AND GROUNDS
4. EQUIPMENT AND UTENSILS
5. SANITARY FACILITIES AND
CONTROLS
6. SANITARY OPERATIONS
7. PROCESSES AND CONTROLS
8. PERSONNEL
3. 1. DEFINITIONS
- the definitions and
interpretations contained
in section 10 of the Food,
Drug and Cosmetic Act (R.A
3720) are applicable to
such terms when used in
this part. The following
shall also apply.
4. (a) "Board" means the Board of Food
and Drug Inspection.
(b) "Secretary" means the Secretary of
Health.
(c) "Department" means the Department
of Health.
(d) "Person" includes individual,
partnership, corporation and
association.
(e) "Food" means (1) articles used for
food or drink for man, (2) chewing gum,
5. (f) "Drug" means (1) articles recognized in
the official United States Pharmacopoeia,
official Homeopathic Pharmacopoeia of the
United States, or official National
Formulary, or any supplement to any of
them; and (2) articles intended for use in
the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or other
animals; and (3) articles (other than food)
intended to affect the structure or any
function of the body of man or animals;
and (4) articles intended for use as a
component of any articles specified in
clauses (1), (2), or (3), but not include
devices or their components, parts, or
6. (g) "Device" means instruments,
apparatus, or contrivances, including
their components, parts, and
accessories, intended (1) for use in the
diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals;
or (2) to affect the structure or any
function of the body of man or animals.
(h) "Cosmetic" means (1) articles
intended to be rubbed, poured,
sprinkled, or sprayed on, introduced
into, or otherwise applied to the human
body or any part thereof for cleansing,
beautifying, promoting attractiveness,
or altering the appearance, and (2)
articles intended for use as a
component of any such articles.
7. (i) "Label" means a display of written, printed,
or graphic matter upon the immediate
container of any article and a requirement
made by or under authority of this Act that any
word, statement, or other information
appearing on the label shall not be considered
to be complied with unless such word,
statement, or other information also appears
on the outside container or wrapper, if any
there be, of the retail package of such article,
or is easily legible through the outside
container or wrapper.
(j) "Immediate container" does not include
package liners.
(k) "Labelling" means all labels and other
written, printed, or graphic matter (1) upon any
article or any of its containers or wrappers,
or (2) accompanying such article.
8. (l) "New drugs" mean:
(1) any drug the composition of which is such that said drug is
not generally recognized, among experts qualified by scientific
training and experience to evaluate the safety of drugs, as safe
for use under the conditions prescribed, recommended, or
suggested in the labeling thereof.
(2) any drug the composition of which is such that said drug, as
a result of investigations to determine its safety for use under
such conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under such conditions.
(m) If an article is alleged to be misbranded because the
labeling is misleading, then in determining whether the
labeling is misleading there shall be taken into account
(among other things) not only representations made or
suggested by statement, word, design, device, or any
combination thereof, but also the extent to which the labeling
fails to reveal facts material in the light of such
representations or material with respect to consequences
which may result from the use of the article to which the
labeling relates under the conditions of use prescribed in the
labeling thereof or under such conditions of use as are
customary or usual.
9. (n) "Food additive" means any substance
the intended use of which results or
may reasonably be expected to result,
directly or indirectly, in its becoming a
component or otherwise affecting the
characteristics of any food (including
any substance intended for use in
producing, manufacturing, packing,
processing, preparing, treating,
packaging, transporting, or holding
food; and including any source of
radiation intended for any such use), if
such substance is not generally
recognized, among experts qualified by
scientific training and experience to
evaluate its safety, as having been
adequately shown through scientific
procedures to be safe under the
conditions of its intended use.
10. (o) “Adequate” means that which is needed to
accomplish the intended purpose in keeping
with good public health practice.
(p) “Plant” means that building or buildings
or parts thereof, used for in connection
with the manufacturing, processing,
packaging, labelling or holding of human
food.
(q) “ Sanitize” means adequate treatment of
surfaces by a process that is effective in
destroying vegetative cells of pathogenic
bacteria in substantially reducing other
microorganisms. Such treatment shall not
adversely affect the product and shall be
safe for the consumer.
11. 2. CURRENT FOOD
MANUFACTURING PRACTICE
(SANITATION).
The criteria in paragraph 3
through 8 shall apply in
determining whether the
facilities, methods, practices, and
controls used in the manufacture,
processing, packing, or holding of
food are in conformance with or
are operated or administered in
conformity with good
manufacturing practices to assure
that food for human consumption
is safe and has been prepared,
packed, and held under sanitary
conditions.
12. 3. PLANT AND
GROUNDS
A. Grounds.
The grounds about a food
plant under the control of
the operator shall be free
from conditions which may
result in the contamination of
food including, but not
limited to, the following:
13. 1. Improperly stored
equipment, litter, waste, refuse
and uncut weeds or grass
within the immediate vicinity of
the plant buildings or
structures that may constitute
an attractant, breeding place,
or harbourage for rodents,
insects and other pests.
14. 2. Excessively dusty roads,
yards, or parking lots that may
constitute a source of
contamination in areas where
food is exposed.
3. Inadequately drained areas
that may contribute
contamination to food
products through seepage or
foot-borne filth and by
providing a breeding place for
15. B. Plant construction and
design.
Plant buildings and structures
shall be suitable in size,
construction, and design to
facilitate maintenance and
sanitary operations for food
processing purposes. The plant
and facilities shall:
16. 1.) Provide sufficient space for such
placement of equipment and storage of
materials as is necessary for sanitary
operations and productions of safe food.
Floors, walls, and ceilings in the plant
shall be of such construction as to be
adequately cleanable and shall be kept
clean and in good repair. Fixtures, ducts, and
pipes shall not be so suspended over
working areas that drip or condensate may
contaminate foods, raw materials, or food-
contact surfaces. Aisles or working spaces
between equipment and between equipment
and walls shall be unobstructed and of
sufficient width to permit employees to
perform their duties without contamination
of food or food-contact surfaces with
clothing or personal contact.
17. 2.) Provide separation by partition,
location, or other effective means for
those operations which may cause
contamination of food products with
undesirable micro-organisms,
chemicals, filth, or other extraneous
material.
3. Provide adequate lighting to hand-
washing areas, dressing and locker
rooms, and toilet rooms and to all
areas where food or food ingredients
and utensils are cleaned. Light bulbs,
fixtures, skylights, or other glass
suspended over exposed food in any
step of preparation shall be of the
safety type or otherwise protected to
prevent food contamination in case of
breakage.
18. 4. Provide adequate ventilation
or control equipment to minimize
odors and noxious fumes or
vapors (including steam) in areas
where they may contaminate
food. Such ventilation or control
equipment shall not create
conditions that may contribute to
food contamination by airborne
contaminants.
5. Provide, where necessary,
effective screening or other
protection against bird, animals,
and vermin (including, but not
limited to, insects and rodents).
19. 4. EQUIPMENT AND
UTENSILS
All plants must be (a) suitable for
their intended use, (b) so designed
and of such material and
workmanship as to be adequately
cleanable, and (c) properly
maintained. The design, construction,
and use of such equipment and
utensils shall preclude the
adulteration of food with
lubricants, fuel, metal fragments,
contaminated water of any other
contaminants. All equipment should
be so installed and maintained as to
facilitate the cleaning of the
equipment and of all adjacent
20. 5. SANITARY FACILITIES AND
CONTROLS
a. Water supply - The water supply shall be
sufficient for the operations intended and
shall be derived from an adequate source.
Any water that contacts food or food
contact surfaces shall be safe and of
adequate sanitary quality. Running water at
a suitable
temperature, and under pressure as needed,
shall be provided in all areas where
required for the processing of food, for the
cleaning of equipment, utensils, and food
packaging materials, or for employee
sanitary facilities.
21. b. Sewage disposal - Sewage
disposal shall be made into an
adequate sewerage system or
disposed of through adequate means.
A food processing or storage facility
will produce both human waste and
liquid processing waste that must be
separated and disposed properly.
Failure to use an adequate sewage
disposal system can lead to
contamination in or outside of the
plant that could lead to
contamination of the facility and the
food you produce.
22. c. Plumbing - plumbing shall be of adequate size
and design and adequately installed and
maintained to:
1. Carry sufficient quantities of water to required
locations throughout the plant.
2. Properly convey sewage and liquid disposable
waste from the plant.
3. Avoid being a source of contamination to food,
water supplies, equipment or utensils or creating
an unsanitary condition.
4. Provide adequate floor drainage in all areas
where floors are subject to flooding type
cleaning or where normal operations release or
discharge water or other liquid waste on the
floor.
5. Provide that there is no backflow from, or
cross connection between, piping systems that
discharge waste-water or sewage and piping
systems that carry water for food or food
23. d. Toilet Facilities - Each plant shall provide
its employees with adequate, readily
accessible toilet facilities. Compliance with
this requirement may be accomplished by:
1. Maintaining the facilities in sanitary
condition.
2. Keeping the facilities in good repair at all
times.
3. Providing self-closing doors that do not
open into areas where food is exposed.
4. Providing doors that do not open into areas
where food is exposed to airborne
contamination, except where alternate means
have been taken to protect against airborne
contamination such as double doors or
positive air flow systems.
26. e. Hand-washing facilities – Adequate
and convenient facilities for hand
washing and where appropriate,
hand sanitizing shall be provided at
each location in the plant where
good sanitary practices require
employees to wash or sanitize and
dry their hands.
f. Rubbish and offal disposal
27.
28. 6. SANITARY OPERATIONS
a. General Maintenance – Building
fixtures and other physical
facilities of the plant shall be
kept in good repair and shall be
maintained in a sanitary condition.
b. Animal and vermin control – No
animals or birds, other than
those essentials as raw materials
shall be allowed in any area of a
food plant.
29. c. Sanitation of Equipment and
Utensils – All utensils and
product-contact surfaces or
equipment shall be cleaned as
frequently as necessary to
prevent contamination of food
and food products
d. Storage and handling of
cleaned portable equipments
and utensils.
30. 7. PROCESSES AND
CONTROLS
All operations in the receiving,
inspecting, transporting, packaging,
segregating, preparing, processing,
and storing of food shall be
conducted in accord with adequate
sanitation principles.
In order to assure that
production procedure do not
contribute to contamination, the
following must be done:
31. a. Raw materials and ingredients shall be
inspected and segregated as necessary to
assure that they are clean, wholesome, and
fit for processing into human food.
b. Containers and carriers of raw
ingredients should be inspected on receipt
to assure that their condition has not
contributed to the contamination or
deterioration of the products.
c. .When ice is used in contact with food
product, it shall be made from potable
water.
32. d. Food processing areas and equipment used
for processing human food should not be
used to process non-human food-grade
animal feed or inedible products unless
there is no reasonable possibility for the
contamination of the human food.
e. Processing equipment shall be maintained
in a sanitary condition through frequent
cleaning including sanitation where
indicated.
f. All food processing, including packaging
and storage, should be conducted under such
conditions and controls as are necessary to
minimize the potential for undesirable
contamination of the processed product or
ingredients.
33. g. Chemical microbiological, or extraneous-
material testing procedures shall be utilized
where necessary to identify sanitation failures
or food contamination, and all foods and
ingredients that have become contaminated shall
be rejected or treated or processed to
eliminate the contamination where this may be
properly accomplished.
h. Packaging processes and materials shall not
transmit contaminats or objectionable
substances to the products, shall conform to any
applicable food additive regulation and should
provide adequate protection from
contamination.
i. Meaningful coding of products sold should be
utilized to enable positive lot identification to
facilitate, where necessary, the segregation of
specific food lots that may have become
contaminated or otherwise unfit for their
intended use.
Storage and transportation of finished products
34. 8.
PERSONNEL
» The Plant management shall
take all reasonable measures
and precautions to assure the
following :
35. A. DISEASE CONTROL
No person affected by disease in
a communicable form or while a
carrier of such diseases, or while
affected with boils, sores, infected
wounds, or other abnormal sources
of microbiological contamination ,
shall work in a food plant in any
capacity in which there is a
reasonable possibility of food or
food ingredients becoming
contaminated by such person, or of
disease being transmitted by such
person to other individuals.
36. B. CLEANLINESS
All persons, while
working in direct contact
with food preparation,
food ingredients, or
surfaces coming into
contact therewith shall:
37. 1. Wear clean outer
garments, maintain high
degree of personal
cleanliness and conform
to hygienic practice
while on duty.
38. 2. Wash hands thoroughly
in an adequate hand-
washing facility before
starting to work.
39. 3. Remove all insecure
jewelry and during
periods where food is
manipulated by hand.
40. 4. If gloves are used in
food handling, maintain
then in an intact, clean and
sanitary condition.
42. 6. Not store clothing or
other personal
belongings, eat food or
drink beverages or use
tobacco in any form in
areas where food or food
ingredients are exposed or
in area used for washing
equipment or utensils.
43. 7. Take any other
necessary precautions
to prevent
contamination of the
food.
44. C. Education and
training
Personnel responsible for
identifying sanitation
failures or food
contamination should have a
background of education or
experiences of a combination
thereof, to provide a level
of competency necessary for
production of clean and safe
food.
