GHP GMP HACP

– Are You Confused?

Ms Shashi Sareen
Sareen,,
Head, Quality
Head
Aditya Birla Retail Limited
 COVERAGE

~ What do we understand by GHP/ GMP &

HACCP

~ Where do the confusions arise?

~ Implementationof GMP & HACCP in export &

d
domestic
ti sector
t – some experiences
i
GMP/GHP, HACCP, Food Safety Management Systems
€ GMP/GHP ‐ All practices regarding    the              
conditions   and   measures   necessary  to                    
ensure the safety and suitability of food at all stages of
ensure the safety and suitability of food at all stages of 
the food chain

€ HACCP ‐ A system which identifies, evaluates and

controls hazards which are significant for food safety

€ Food Safety Management Systems ‐ A holistic system of

controls that manage food safety in food business.
Includes GHPs; HACCP; management systems elements
& policies; and traceability/ recall systems
 GMP/ GHP
€ Primary production
€ Establishment design & facilities – location, premises & 
rooms, equipment, facilities
i t f iliti
€ Control of operations
€ Establishment: maintenance & sanitation
Establishment: maintenance & sanitation* –
maintenance & cleaning, pest control, waste 
management
€ Personal Hygiene* – health status, illnesses, personal 
cleanliness, behaviour, visitors
€ Transportation –
T t ti d i
design, use & maintenance
& i t
€ Product information & consumer awareness –
identification, prod info, labelling, consumer education
identification, prod info, labelling, consumer education
€ Training
 HACCP
€ ll accepted
An internationally d methodology
h d l d
to reduce
and manage risk

€ A preventive system for food safety that addresses

chemical physical and biological risk
chemical,

€ TTreats
t the
th production
d ti off food
f d as a total,
t t l continuous
ti
system, assuring food safety from harvest to
consumption

€ 7 Principles & 12 Steps

 HACCP Principles
€ d a hazard
Conduct h d analysis
l
€ Determine the CCPs
€ Establish Critical Limits
€ Establish a system to monitor Control of the CCPs
€ Establish the Corrective Actions to be taken when
monitoring indicates that a particular CCP is not in
control
€ Establish Procedures for Verification to confirm that
the HACCP System is working effectively
€ Establish documentation concerning all procedures and
records appropriate to these Principles and their
application
 HACCP – 12 Steps
€ Assemble HACCP Team
€ Describe Product
Pre -Steps
€ Identifyy intended Use
€ Construct Flow Diagram
€ Onsite Confirmation of Flow Diagram
€ List all potential hazards associated with each step, conduct
a hazard analysis & consider any measures to control
identified hazards
€ Determine the CCPs
€ Establish Critical Limits for each CCP
€ Establish
bl h a monitoring system forf eachh CCP
€ Establish Corrective Actions
€ Establish Verification Procedures
€ Establish documentation & Record Keeping
10 POINTS OF
10 POINTS OF

CONFUSION
 1. Differences between GMP & GHP
€ Pre requisite progs which provide basic envt & operating
conditions for production of safe food & are a prerequisite to
a successful implementation of HACCP

¾ GMP – manufacture & process controls & includes supplier

control;; specifications;
p ; calibration of equipment;
q p ; traceabilityy
& recall; equipment designs where conditions for food safety
can be achieved, maintained & monitored; lighting &
ventilation systems;
y ; storage
g conditions;; control of operations
p

¾ GHP – system/ measures for maintaining hygiene &

sanitation & include personal hygiene & employee health
conditions, maintenance of plant & eqpt hygiene including
food contact surfaces, pest control, waste disposal, water
quality toilet & hand wash facilities,
quality, facilities prevention of cross
contamination
 2 GMP Li k T HACCP
2. GMP Link To HACCP
¨GMP through out the facility
HACCP process specific

¨Low risk hazards controlled through GMP
¨Low risk hazards controlled through GMP
Many hazards controlled through GMP

¨HACCP takes care of significant hazards not controlled 
by PRPs/GMPs

¨All the pre‐requisite programmes to be in place 
before embarking on a HACCP prog
Relationship between GMP & HACCP

€ GMP including GHP outline the measures to be taken to

ensure that premises, equipment, transport and
employees
l d not contribute
do b to or become
b f d safety
food f
hazards
€ Codex 4th revision stresses that – Prerequisite
programmes to HACCP including training should be well
established, fully operational & verified in order to
facilitate the successful application & implementation of
the HACCP system
3. Hazard Analysis & Risk Analysis
€ Hazard Analysis
¾Identification of potential hazards & in execution of a 
hazard analysis, the risks are assessed for level of control to 
be implemented for control of hazard
¾Basis 
Basis – likelihood of occurrence & severity of 
likelihood of occurrence & severity of
consequences
€ Risk Analysis
¾SPS Agreement – Article 5: Countries must establish SPS
measures on the basis of an appropriate assessment of the
actual risks involved,
involved &,& if requested make known the
factors taken into consideration, the assessment procedures
used & level of risk they determined to be acceptable.
¾Codex Risk Analysis ‐ 3 components : risk assessment, risk
management and risk communication
 Risk Analysis
€ Risk Assessment
¾ Identify the immediate, interim & long term effect on 
human health
¾ Covers hazard identification, hazard characterization, 
, ,
exposure assessment, risk characterization
€ Risk Management
¾ To establish appropriate measures of control to 
prevent, reduce or minimise the risks
€ Risk Communication
¾ To determine the best way to communicate the 
information to affected populations
 4. CCPs – Some Issues

€ CCP – step at which control can be applied & is essential

to prevent (from introduction in product) or eliminate a
food safety hazard or reduce to acceptable levels
¾ Absence of CCPs – Is it a HACCP or a GMP
System?
¾ Raw material checking & testing at entry point –
Is it a CCP?
¾ Which
Whi h i a better
is b system – with
i h more or less
l
CCPs?
¾ Control of hazards through CCP or GMP ?
 HONEY PROCESS FLOW
Collection of Hazards – Pesticide residues , 
Hazards  Pesticide residues
Raw Honey Chloramphenicol

Transportation in 
D
Drums /Bag in Bag to Processor
/B i B t P

Melting in Decrystallizers (~35
g y ( 0 C))

Filtering in Different Mesh Size

Filtering in Different Mesh Size Hazards – – physical 
impurities like hair, plastic

Settling  ‐ 12hrs  & Online filter

Heating under Vaccuum (<50)

Hazards – insects through 
Packing (Bulk/Customer Packs) GMP/ CCP
 5. Verification & Validation
€ Validation
¾ Objective is to ensure that hazards identified are 
complete & correct & will be effectively 
controlled by HACCP Plan
¾ Requires objective evidence that all elements of 
R i bj i id h ll l f
HACCP Plan are effective
€ Verification
¾ Objective is to determine compliance with the 
HACCP system (Plan)
HACCP system (Plan)
¾ Methods include – auditing, random sampling & 
analysis 
analysis
€ Examples – hand swabs, pasteurization
6. Systems Elements not mentioned in HACCP –
are these essential/ important?
/ p

€ Management responsibility –
g p y mgmt commitment, 
g
food safety policy, responsibility & authority
€ Document control/ record control
€ Management review
€ Resource Management
g
€ Control of monitoring & measuring – methods & 
equipment
€ Internal audits
€ Improvements 
p
 7. Does HACCP Address Quality/ Safety?

€ HACCP defined as a system which identifies, 
evaluates & controls hazards which are 
evaluates & controls hazards which are
significant for food safety. Basically designed 
to address safety
to address safety
€ However can be applied to other aspects of 
food quality also (as mentioned in preamble)
food quality also (as mentioned in preamble) 
“While the application of HACCP to food safety was 
considered here, the concept can be applied to other aspects 
considered here, the concept can be applied to other aspects
of food quality”
€ Also apply to other industries; egs –
pp y ; g medical, ,
oil, explosives, drugs
 8. Application to Primary Production?

€ Hazards are due to environment (Cd), pests & 
diseases of animals & plants & from measures to 
diseases of animals & plants & from measures to
control these, contaminants, hygienic conditions
€ Hazards associated with primary production may 
p yp y
or may not be eliminated or reduced to 
acceptable levels – depends on subsequent 
processing/ handling (eg
i / h dli ( e.colili in lettuce, vibrios
i l tt ib i
in seafood, vd residues in animal products)
€ Good practice recommendations need to be 
Good practice recommendations need to be
followed with the aim of ensuring food safety & 
wholesomeness (GAP/ GAHP) –
wholesomeness (GAP/ GAHP) aimaim is that 
is that
hazards not introduced
 9. WHO SHALL BE RESPONSIBLE?
€ THE PROCESSOR
¾Processors are responsible for
¾upgrading the facility
¾designing the HACCP system
¾Implementing it; &
Implementing it; &
¾ documenting & maintaining records  

€ THE GOVERNMENT
¾Governments are responsible for 
p
creating a scientific, technical & financial 
environment favorable to HACCP 
implementation 
 10. Cost Implications

€ Costs of consultants
€ Certification
€ Manpower time & training costs
Manpower time & training costs
€ Cost – benefit studies not available
€ Lack of data & studies relating to impact of 
L k f d t & t di l ti t i t f
HACCP on food safety ‐ Visible benefits not 
evident
id t
¾ Implemented due to external pressures 
(export, retail, buyers)
 10 Points of Confusions!!
ff
1. Difference b
between GHP & GMP
2. Relationship between GHP & HACCP
3 Hazard
3. H d analysis
l i & Risk
Ri k analysis
l i – difference
diff
4. CCP – Some Issues
5 Verification & Validation
5.
6. Aspects like calibration, internal audits are not
mentioned in HACCP – are these essential//
important?
7. Can HACCP address quality or only safety?
8. Implementation in primary production
9. Whose responsibility is the implementation
10 Cost
10. C t off implementation
i l t ti
IMPLEMENTATION IN EXPORT/ 
DOMESTIC SECTOR : SOME 
EXPERIENCES
 Some Experiences

€ Export
¾Mandatory GMP/ HACCP for fishery, dairy, egg 
products, poultry meat, honey
¾N f i
¾No of units certified > 500
ifi d 500
¾Voluntary Schemes – eg Globalgap, retail, etc
€ Domestic Sector
¾Legislation – MMPO, FPO: GMP/GHP
¾Mandatory BIS Standards – water, infant milk foods
¾Retail 
 ISSUES OF CONCERN
€ Although GMP/HACCP implemented/certified – lots of 
Although GMP/HACCP implemented/certified – lots of
gaps‐ deficiencies relate to implementation; 

¾ GHP & Adherence : Poor Pest Control (Birds, Flies, Insect), Poor 
personal Hygiene (caps, footwear, jewellery, glass bangles), 
unhygienic processing conditions
¾ GMP & Continuance: Plant  Layout design (sheds, m/c, Eqpt),  
& Continuance: Plant Layout design (sheds m/c Eqpt)
Equipments (maintenance & calibration); Storage & 
transportation conditions (eg. broken thermographs); Shelf life 
monitoring & maintenance of control samples; Testing & control 
on  RM/PM materials & cross contamination
¾ Traceability lacking
¾ Poor Record keeping w.r.t. Lot/Batch preparation details , No 
availability of sampling plan , On‐line checks & Non availability 
il bili f li l O li h k &N il bili
of basic working QC lab. 
¾ Legislation ‐ Not addressed both of importing country/ 
domestic – not even understood eg
domestic  not even understood eg fumigation, Non‐adherence 
fumigation Non‐adherence
to PCRO regulation, W&M Act
 ISSUES OF CONCERN

€ Management commitment lacking
¾ Systems copied
¾ Lack of understanding of entire process – CCP & GMP
¾ Once certified, processor neglects the system as 
surveillance not effective & frequent
¾ Sampling procedures not correctly followed
¾ Qualified personnel; 
¾ No commitment for food/ product safety
¾ Certification important & not Implementation
HACCP or GMP??

No Need to get Confused

Important is to get started & Implement

Aim is SAFE FOOD

ANY QUESTIONS?