Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to the quality standards. There are many risks: unexpected contamination of products, causing damage to health or even death; incorrect labels on container, etc. This webinar will guide you through all of the requirements, steps you need to take going from concepts to implementation of appropriate measures. Main points covered: • Current good manufacturing practice (CGMP) requirements • A Quality Management System for medical devices Required By FDA (Food & Drug Association) USA • From Concepts to implementation Presenter: This webinar was presented by PECB Certified Trainer, who is also a senior consultant, trainer and coach in Occupational Health and Safety, Mr. Raza Shah. Link of the recorded session published on YouTube: https://youtu.be/9ZTtnAQn3HQ

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PRACTICESPRACTICES
Training about our Food Safety PlanTraining about our Food Safety Plan

2. Raza Shah
Consultant, Lead auditor & Chief Editor
Raza Shah has completed his course work for MS in Project Due to his interest in managementRaza Shah has completed his course work for MS in Project Due to his interest in management
systems he has done lead auditor courses for ISO 9000,ISO 14000, OHSAS 18001, ISOsystems he has done lead auditor courses for ISO 9000,ISO 14000, OHSAS 18001, ISO
26000,ISO22000,ISO 13485 and SA 8000 Advance Lead Auditor. He has been educating the26000,ISO22000,ISO 13485 and SA 8000 Advance Lead Auditor. He has been educating the
students of MBA in different institution as a visiting faculty member.students of MBA in different institution as a visiting faculty member. He is working as a ChiefHe is working as a Chief
Editor of “Monthly Bitehqeeq” to promote the research culture in Pakistan.Editor of “Monthly Bitehqeeq” to promote the research culture in Pakistan.
0092321614357400923216143574
razashah801@gmail.comrazashah801@gmail.com
www.bitehqeeq.comwww.bitehqeeq.com
linkedin.com/raza-shah-76393314
twitter.com/razashah801twitter.com/razashah801
fb.com/raza.u.shahfb.com/raza.u.shah

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HACCPHACCP ACRONYMACRONYM
HH azzard
AA nalysis
CC ritical
CC ontrol
PP oint

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HISTORY OF THEHISTORY OF THE HACCPHACCP
SYSTEMSYSTEM
 HACCPHACCP was developed in the 1960’s when NASA askedwas developed in the 1960’s when NASA asked
Pillsbury to design and manufacture the first food forPillsbury to design and manufacture the first food for
space flightsspace flights
 The growing concern about food safety from public healthThe growing concern about food safety from public health
authorities, the Food Industry and consumers world wideauthorities, the Food Industry and consumers world wide
has been the major force in the introduction of thehas been the major force in the introduction of the
HACCPHACCP system. Todaysystem. Today HACCPHACCP is acceptedis accepted
internationally as a useful tool for adapting traditionalinternationally as a useful tool for adapting traditional
inspection methods to a modern, science based, foodinspection methods to a modern, science based, food
safety system.safety system. HACCPHACCP has become thehas become the globallyglobally
recognized method to ensure food safetyrecognized method to ensure food safety

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WHAT ISWHAT IS HACCPHACCP??
 HACCPHACCP is ais a systematic, preventativesystematic, preventative approach to food safety.approach to food safety.
It aims toIt aims to preventprevent biological, chemical and physical hazards,biological, chemical and physical hazards,
instead of relying on finished product inspection. HACCP is usedinstead of relying on finished product inspection. HACCP is used
in the food industry to identifyin the food industry to identify potentialpotential food safetyfood safety hazardshazards, so, so
that key actions, known as Critical Control Points (CCPs) can bethat key actions, known as Critical Control Points (CCPs) can be
used to reduce or eliminate the identified hazards.used to reduce or eliminate the identified hazards.
 With HACCPHACCP the food processor systematically:
 Identifies potential food safety hazards (Hazard Analysis).
 Determines the key steps in their operation where the
hazards can be prevented, eliminated or reduced to an
acceptable level. (The key steps are known as Critical
Control Points or CCPs)

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KEY CONCEPTS OF AKEY CONCEPTS OF A
HACCPHACCP PLANPLAN
 Good Manufacturing Practices (Good Manufacturing Practices (GMPGMPs)s)
 Standard Operating Procedures (Standard Operating Procedures (SOPSOPs)s)

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SOP’s ALLOW YOU TO:SOP’s ALLOW YOU TO:
1.1. SAYSAY what you dowhat you do
2.2. DODO what you saywhat you say
3.3. PROVEPROVE itit

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WHAT ARE CCPsWHAT ARE CCPs
(Critical Control Points)(Critical Control Points) ??
 AA CCPCCP is a key step where hazardsis a key step where hazards
can be prevented, eliminated orcan be prevented, eliminated or
reduced to an acceptable level.reduced to an acceptable level.

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THE SUCCESS OFTHE SUCCESS OF HACCPHACCP
AND THE SEVENAND THE SEVEN
PRINCIPLESPRINCIPLES
1.1. Identify HazardsIdentify Hazards
2.2. Determine Critical Control Points (Determine Critical Control Points (CCPsCCPs))
3.3. Establish Critical LimitsEstablish Critical Limits
4.4. Establish Monitoring ProceduresEstablish Monitoring Procedures
5.5. Establish Corrective Action ProceduresEstablish Corrective Action Procedures
6.6. Establish Verification ProceduresEstablish Verification Procedures
7.7. Establish Record KeepingEstablish Record Keeping

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PREREQUISITEPREREQUISITE
PROGRAMSPROGRAMS
A.A. Premises (including water supply)Premises (including water supply)
B.B. Transportation, Receiving and StorageTransportation, Receiving and Storage
C.C. Equipment Design, Installation and MaintenanceEquipment Design, Installation and Maintenance
D.D. Personnel TrainingPersonnel Training
E.E. Sanitation & Pest ControlSanitation & Pest Control
F.F. RecallRecall

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GOOD MANUFACTURINGGOOD MANUFACTURING
PRACTICES (GMPs)PRACTICES (GMPs)
 You can control many of the potential hazards in aYou can control many of the potential hazards in a
processing plant by using aprocessing plant by using a standard set ofstandard set of
principles and hygienic practicesprinciples and hygienic practices for thefor the
manufacturing and handling of food. These standardmanufacturing and handling of food. These standard
principles and practices are calledprinciples and practices are called GoodGood
Manufacturing PracticesManufacturing Practices ((GMPsGMPs))

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GMPs ARE:GMPs ARE:
 Preventative measures to ensure food safetyPreventative measures to ensure food safety
 Based on practical experience over a longBased on practical experience over a long
period of timeperiod of time
 The foundation on which to build aThe foundation on which to build a HACCPHACCP
programprogram

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STANDARD OPERATINGSTANDARD OPERATING
PROCEDURES (SOP’s)PROCEDURES (SOP’s)
 The purpose and frequency of doing a taskThe purpose and frequency of doing a task
 Who will do the taskWho will do the task
 A description of the procedure to be performedA description of the procedure to be performed
 What paperwork is to be completed (documentation)What paperwork is to be completed (documentation)
 The method by which you show that task is satisfactorilyThe method by which you show that task is satisfactorily
completedcompleted
 And the corrective actions to be taken of the task isAnd the corrective actions to be taken of the task is
performed incorrectlyperformed incorrectly

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CORRECTIVE ACTIONCORRECTIVE ACTION
REQUESTREQUEST
 A CAR must beA CAR must be
completed for eachcompleted for each
deviation from the SOPdeviation from the SOP
 CAR FormCAR Form
 CAR InstructionsCAR Instructions
 State deviationState deviation
 Use objective EvidenceUse objective Evidence
 Develop an action planDevelop an action plan
to prevent deviationto prevent deviation
reoccurrencereoccurrence
 Set a deadlineSet a deadline
 Verify that the actionVerify that the action
plan has been effectiveplan has been effective

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: PREMISESPREMISES
 Building ExteriorBuilding Exterior
 Building Interior:Building Interior: Design, Construction, Lighting,Design, Construction, Lighting,
Ventilation, Waste Disposal, Inedible AreasVentilation, Waste Disposal, Inedible Areas
 Sanitation Facilities:Sanitation Facilities: Employee Facilities,Employee Facilities,
Equipment Cleaning & Sanitizing FacilitiesEquipment Cleaning & Sanitizing Facilities
 Water/Ice Quality and SupplyWater/Ice Quality and Supply

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: PREMISESPREMISES
 Premises SOPPremises SOP
 Monitoring Procedure: part of internalMonitoring Procedure: part of internal
audit proceduresaudit procedures

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PREREQUISITE PROGRAM:PREREQUISITE PROGRAM:
TRANSPORTATION, RECEIVING &TRANSPORTATION, RECEIVING &
STORAGESTORAGE
 Receiving:Receiving: Food Carriers, Temperature Control,Food Carriers, Temperature Control,
Approved SuppliersApproved Suppliers
 Storage:Storage: Ingredient, Allergen, Finished ProductIngredient, Allergen, Finished Product
and Chemical Storageand Chemical Storage
 Transportation:Transportation: Food Carriers, TemperatureFood Carriers, Temperature
ControlControl

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: TRANSPORTATION,TRANSPORTATION,
RECEIVING & STORAGERECEIVING & STORAGE
 Transportation Receiving and Storage SOPTransportation Receiving and Storage SOP
 Monitoring Procedures: check each shipment,Monitoring Procedures: check each shipment,
 CAR: exampleCAR: example
 Allergen ProgramAllergen Program
 Approved Suppliers ProgramApproved Suppliers Program

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: EQUIPMENTEQUIPMENT
 Equipment Design and InstallationEquipment Design and Installation
 Equipment Maintenance and CalibrationEquipment Maintenance and Calibration
 Equipment SOPEquipment SOP
 Temperature Monitoring LogTemperature Monitoring Log
 Thermometer CalibrationThermometer Calibration

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: PERSONNELPERSONNEL
 Training: Hygiene and TechnicalTraining: Hygiene and Technical
 Hygiene and Health RequirementsHygiene and Health Requirements
 Personnel SOPPersonnel SOP
 Employee Sanitation SOPEmployee Sanitation SOP
 Visitor Log BookVisitor Log Book

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PREREQUISITEPREREQUISITE
PROGRAMS:PROGRAMS: Sanitation &Sanitation &
Pest ControlPest Control
 SANITATIONSANITATION
 PEST CONTROLPEST CONTROL
 SOPSOP
 PREOPS CHECKLISTPREOPS CHECKLIST
 TRUCK CLEANING LOGTRUCK CLEANING LOG

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PREREQUISITEPREREQUISITE
PROGRAM:PROGRAM: RECALLRECALL
 The Recall SystemThe Recall System
 Complaints LogComplaints Log
 Complaints Log SOPComplaints Log SOP
 Recall TemplateRecall Template
 Recall NoticeRecall Notice
 Allergen Alert NoticeAllergen Alert Notice

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CRITICAL LIMITSCRITICAL LIMITS
 Is a value which separates acceptability fromIs a value which separates acceptability from
unacceptabilityunacceptability
 Critical Limits must meet or exceed governmentCritical Limits must meet or exceed government
regulationsregulations
 One or more critical limit must be met to ensureOne or more critical limit must be met to ensure
a CCP is controlling the hazarda CCP is controlling the hazard

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CRITICAL LIMITSCRITICAL LIMITS
 Temperature / TimeTemperature / Time
 pHpH
 Aw (available water)Aw (available water)
 PreservativesPreservatives
 Available chlorineAvailable chlorine
 Sensory observationsSensory observations

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SOURCES OF CRITICALSOURCES OF CRITICAL
LIMITSLIMITS
 Regulatory StandardsRegulatory Standards
 Company StandardsCompany Standards
 Literature SurveysLiterature Surveys
 Experimental StudiesExperimental Studies
 Expert AdviceExpert Advice

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CRITICAL LIMITSCRITICAL LIMITS
 Individual Product ProfilesIndividual Product Profiles
 Process Control SheetProcess Control Sheet

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PRODUCTIONPRODUCTION
RECORDSRECORDS
 Using CIMS to record ingredients, batchUsing CIMS to record ingredients, batch
processing and finished productprocessing and finished product
informationinformation

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IMPORTANCE OFIMPORTANCE OF
VERIFICATIONVERIFICATION
 Ensures that all major processing steps haveEnsures that all major processing steps have
been identifiedbeen identified
 Validates the assumptions made regarding theValidates the assumptions made regarding the
movement of employees and productmovement of employees and product
 Works towards continual improvement of theWorks towards continual improvement of the
GMP systemGMP system

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IMPORTANCE OFIMPORTANCE OF
VERIFICATIONVERIFICATION
 Internal AuditInternal Audit
 Internal Audit TemplateInternal Audit Template
 Label ReviewLabel Review

30. ??
QUESTIONS
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