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UNIT 19
GMP (Good manufacturing practices)
FSSAI has specified procedures and p
8 to be followed by food businesses to prevent the occurrence
‘of food bome illnesses by actively controlling hazards throughout the food supply chain, Every food busines
‘operator is required to have a documented FSMS plan and to comply with Schedule IV of the F'8S (Licensing and
Registration of Food Businesses) Regulations 2011, Schedule IV introduces the concept of PSMS based on
implementation of Good Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) by food businesses,
‘Technical Panels of eminent domain experts have been set up to review and update FSMS standards, draft
and review Good Hygiene practices (GHP) and Good Manufacturing Practices (GMP) by food category, identify
‘gaps if'any and prescribe new schedules and process standards wherever required from time to time.
‘To provide assurance of food safety, Food businesses must implement an effective Food Safety Management
‘System (FSMS) based on Hazard Analysis and Critical Control Point (HACCP) and suitable pre- requisite
programmes by actively controlling hazards throughout the food chain starting from food production till final
‘consumption.
‘As per the condition of license under FSS (Licensing & Registration of Food Businesses) Regulations 201
every food business operator (FBO) applying for licensing must have a documented FSMS plan and comply with
schedule 4 of these regulations. Schedule 4 introduces the concept of FSMS based on implementation of Good
Manufacturing Practices (GMP) and Good Hygiene Practices (GHP) by food businesses and is divided into two parts
asunder:
Part 1 - General hygienic and sanitary practices to be followed by food business operators applying for registration
~ Petty food operators (Food Safety & Standards (Licensing and Registration of food Business) Regulations, 2011
‘© Every petty Food Business Operator shall register them with the Registering Authority by submitting an
‘pplication for registration in Form A under Schedule 2 of FSSAI 2011 Regulations along with a fee as
provided in Schedule 3
‘© The petty food manufacturer shall follow the basic hygiene and safety requirements provided in Part I of
Schedule 4 of these Regulations and provide a self-attested declaration of adherence to these requirements
with the application in the format provided in Annexure-1 under Schedule 2.
The Registering Authority shall consider the application and may either grant registration ot reject it with
reasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application for
registration,
«In the event of an inspection being ordered, the registration shall be granted by the Registering Authority
after being satisfied with the safety, hygiene and sanitary conditions of the premises as contained in Part II
‘of Schedule 4 within a period of 30 days.
«If registration is not granted, or denied, or inspection not ordered within 7 days as provided in above sub
regulation (3) or no decision is communicated within 30 days as provided in above sub regulation (4), the
petty food manufacturer may start its business, provided that it will be incumbent on the Food Business
‘Operator to comply with any improvement suggested by the Registering Authority even later. Provided that
registration shall not be refused without giving the applicant an opportunity of being heard and for reasons
to be recorded in writing.
‘© The Registering Authority shall issue a registration certificate and a photo identity card, which shall be
displayed at a prominent place at all times within the premises or vehicle or cart or any other place where
the person carries on sale/manufacture of food in case of Petty Food Business.
«The Registering Authority or any officer or agency specifically authorized for this purpose shall carry out
food safety inspection of the registered establishments at least once in a year.
‘AS48305 Sangeeta, DISTPart 2 - General hygienic and sanitary practices to be followed by food business operators applying for licens
Manufacturing/ provessing/ packaging/storage/distribution
As per Section 31(1) & 31(2) of FSS Act, 2006 every Food Business Operator in the country is required to be
Ticensed/registered under the Food Safety &Standards Authority of India. The licensing and registration procedure
and requirements are regulated by Food Safety & Standards (Licensing and Registration of food Business)
Regulations, 2011. Registration is meant for petty food manufacturers that includes petty retailer, hawker, itinerant
‘vendor or a temporary stall holder or small or cottage scale industry having annual turnover up to 12 lacs, All food
businesses having income more than this limit are required to take a license, The document, based on the product
‘category, can be used by the FBOs (food business operators) as per the operations applicable to them
General Hygienic and Sanitary practices to be followed by Food Business operators
(Schedule 4)
The establishment in which food is being handled, processed, manufactured, stored, distributed by the food business
‘operator whether holder of registration certificate or a license as per the norms laid down in these regulations and
the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other
standards as specified below. It shall also be deemed to be the responsibility of the food business operator to ensure
adherence to necessary requirements. These are the basic - compulsory requirements for ensuring safety of the food
‘manufactured in any premise and FBOs shall continuously try to improve the sanitary and hygienic conditions at the
premises with a goal of attaining India HACCP standards within a - previously determined period.
FSSAI has issued a guidance document on Food Safety Management System (FSMS) to implement GMP (good
‘manufacturing practicesGHP (good hygiene practices) requirements for fruit and vegetable products. This
document is applicable for food businesses involved in the fruit and vegetable sector, which includes; Thermally
processed Fruits, vegetables, Vegetable Soups, Fruits Juices, Pulp/Puree, Fruit Nectars, pickles ete.
‘Some important regulations are given for general hygienic and sanitary practices to be followed by petty food
‘business operators applying for registration (Regulation 2.1.1(2))
The premises shall be located in a sanitary place and free from filthy surroundings and shall maintain overall
hygienic environment. All new units shall set up away from environmentally polluted areas.
The premises to conduct food business for manufacturing should have adequate space for manufacturing and
storage to maintain overall hygienic environment.
‘The premises shall be clean, adequately lighted and ventilated and sufficient free space for movement.
Floors, Ceilings and walls must be maintained in a sound condition. They should be smooth and easy to
clean with no flaking paint or plaster.
“The floor and skirted walls shall be washed as per requirement with an effective disinfectant the premises
shall be kept free from all insects.
* Continuous supply of potable water shall be ensured in the premises. In case of intermittent water supply
adequate storage arrangement for water used in food or washing shall be made.
Equipment and machinery when employed shall be of such design which will permit easy cleaning
‘Arrangements for cleaning of containers, tables, working parts of machinery, etc. shall be provided
‘No vessel, container or other equipment, the use of which is likely to cause metallic contamination injurious
to health shall be employed in the preparation, packing or storage of food. (Copper or brass vessels shall
have proper lining).
All eqequipmenthall be kept clean, washed, dried and stacked at the close of business to ensure freedom
from growth of mould/ fungi and infestation.
Al equipments shall be placed well away from the walls to allow proper inspection
Good Hygiene Practices (GHP)
APS 483, Dr. S. Sangeeta, FSTP) process isan important component ofall Quality Programs.
the laboratory is planned, performed,
that provides the framework within which
including; implementing, validating and maintaining the laboratory
iis important for laboratory success, but isnt necessarily
that are critical components of successful laboratory
ful quality assurance program are also required forNovel Technologies in Food Preservation 297
15, HACCP
HACCP (Hazard Analysis and Critical Control Point) is a
control system designed to identify and prevent or minimize
different kinds of hazards of microbial / biological, chemical
or physical origin, in the process of food production It
emphasizes upon various steps designed to prevent problems
or hazards before they actually occur and to correct them as
soon as they are detected.
Hazard
Itrefers to a potential undesirable and unacceptable danger
of (i) biological origin (bacteria, viruses, protozoa, moulds,
parasites etc.), (ii) chemical origin (toxins, pesticides, heavy
metals, preservatives, colours and other additives etc.) or (iii)
physical origin (fine glass pieces, metal fragments, stones, wood
splinters etc.). Therefore, a food safety hazard is any biological,
chemical, or physical cause that may make the food unsafe for
human consumption.
Seven Principles / Components of HACCP
1. Hazard Analysis: Identify the potential hazards, assess their
extent of severity and the probability of occurrence of hazards.
2. Critical Control Points: Determine the critical control points
(CCPs). CCP is a point, stage, raw material, practice,
formulation, process, step, OF procedure in a food
production process at which we can apply control
(measures) and the hazard can be prevented, eliminated,
or reduced to an acceptable level.
3. Critical limits for each CCP: Determine the critical limits
‘for each CCP. Critical limits are the maximum or minimum
values that will make a demarcation between the
acceptability or unacceptability. Crossing any critical limit
may make the stage, raw material, practice, formulation,
process, step, or procedure, unacceptable in safe food
production process.298 Postharvest Management and Processing
4, Monitoring: Monitor the manufacturing process continuously
Itis necessary to check the effectiveness of a control and
ensure that the process is under control (within acceptable
limits) at each CCP,
5. Corrective actions: Take prompt corrective actions. When
monitoring indicates chances of any deviation from th
established critical limits, prompt corrective actions ar
taken to ensure that no product injurious to health or _
otherwise adulterated as a result of the deviation is
manufactured or enters the market,
» Record Keeping: Maintain the HACCP documents. The
documents including hazard analysis, written HACCP —
plan, monitoring of critical control points, critical limits,
verification activities and handling of processin,
deviations is necessary for validation, verification, review, 3
auditing, improvement etc.
7. Validation and Verification: Establish procedures for
ensuring that HACCP system is working as intended
“Validation” of the HACCP plans ensures that the
production plants are successful in ensuring thi
production of safe products. “Verification” is done to che
overall effectiveness of the HACCP system and ensure:
that the HACCP plan is adequate, and working a:
intended. Verification procedures may include review o
HACCP plans, CCP records, critical limits and microbial
sampling and analysis.
Why HACCP?
1, HACCPisnecessary to ensure safe manufacture of various
food items.
2. India a signatory of Sanitary and Phytosanitary (SPS) _
agreement. Therefore, we have to adopt standard
guidelines and recommendations issued by FAO/WHO ~
Codex Alimentarius Commission, for international trade,
which also includes adoption of HACCP.|
Novel Technologies in Food Preservation ”
3. HACCP is mandatory for export from certain sectors ol
food industries to some countries.
Applications
HACCP has applications in various industries including
juice, seafood, meat, poultry, cosmetics, pharmaceutical and
various processed food industries.
Conception
HACCP was conceived in 1960s when the US National
Aeronautics and Space ‘Administration (NASA) asked
“Pillsbury” to design and manufacture the first foods for space
flights. Since then, HACCP is recognized at international level
as a logical tool for adapting conventional inspection methods
to a modern, science-based, food safety system. HACCP allow
both industry and government to allocate their resources
officiently in establishing and auditing safe food production
practices.
Points 10 REMEMBER
HACCP stands for Hazard ‘Analysis Critical Control Point
This system is designed to identify and prevent or minimize
different kinds of hazards of biological / microbial, chemical or
physical origin
Hazard refers to a potental undesirableandunacceptsble danger
.cteria, viruses, protozoa, moulds, parasites
heavy metals,
, sical origin
gments, stones, wood )
‘There are seven principles or components of HACCP
a point, stage, raw material,
Critical Control Point (CCP) is
,, formulation, process, step, or procedure ina food
ction process at which we can apply control (measures)
production Prg can be prevented, eliminated, oF reduced 192°
acceptablelevel.
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