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
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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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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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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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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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