haccp gamp .final 2015 rakesh
TRANSCRIPT
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Presented by:-Mr. Wani Rakesh.M.
M.Pharm, Ist Sem(QAT)
Guided by:-Prof. Mr. Bidkar A.A.
HOD Pharmacognosy
Date of Presentation:- 06/11/2015
Emerging concept in qa-haccp and gamp
Sinhgad institute of pharmacy narhe, Pune
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Contents: Introduction
Objective
History of HACCP
Pre HACCP Activities
Principal
Advantages
Application
Conclusion
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Introduction: -
The Hazard Analysis Critical Control Points (HACCP) system is
a logical, scientific system that can control safety problems in food
production.
It works with any type of food production system and with any food.
The hazards can be biological, chemical, or physical.
Used for the identification of Critical Control Points (CCP’s)
where food safety concerns can be identified.When critical limits are exceeded, corrective action must be taken
and documented.
www.usda.gov
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Prevent, reduce or eliminate hazards in food and in Pharmaceuticals.
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Objective: -
To make product safely and be able to prove it
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History of HACCP
The concept had its origin in USA.
1958-59; Concept was discussed and developed at NASA.
1971; The HACCP system was published and documented.
1985; The National Academy of Science (NSA) recommended the use of
the system.
1988; National Advisory Committee on Microbiological Criteria for
Food (NACMCF).
1989; NACMCF proposed 7 principles of HACCP.
1st revision in 1992,
2nd revision in 1997 ; published in Journal of Food protection.
www.haccp-international.com
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Need for HACCP system
Failure of inspection procedures to prevent hazards from being
present on foods.
End-product testing does not guarantee the safety of the product.
Examination of entire lots is not feasible (Sampling plans).
Allows to provide consumers with safe foods.
It is the Law…!!!
Dr. Hany Khalil, Professor of food science, California state university, California.
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Where can HACCP be used?
HACCP can be used in any food sector from production to retail
HACCP
Production
Processing
TransportRetail and food service
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The 7 Principles of HACCP
1. Conduct a Hazard Analysis
2. Determine Critical Control Points
3. Establish Critical Limits
4. Establish Monitoring Procedures
5. Establish Corrective Actions
6. Establish Verification Procedures
7. Establish Record keeping and Documentation
www.haccpindia.org
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Before starting HACCP plan one must conduct….
Pre HACCP Activities
1. Assemble the HACCP team
2. Describe the food and its distribution method
3. Identify the intended use and target consumer for the product
4. Develop a flow chart describing the process
5. Verify the flowchart
www.haccpindia.org
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7 principles cont…
Principle 1: - Conduct a hazard analysis –
Hazard identificationHazard evaluation (biological, chemical, or physical)Prepare a list of steps in the process where significant hazards
may be introduced or increased.Use the process flow chartSummarize the information in a Hazard Analysis Worksheet
Dr. Hany Khalil, Professor of food science, California state university, California.
12Almond board of California, USA
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*`
Almond board of California, USA
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2. Determine Critical Control Points –
Point, step or procedure where a control measure is applied and the
control is necessary at that point to keep a safe production.
Dr. Hany Khalil, Professor of food science, California state university, California.
15Almond board of California, USA
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3. Establish Critical limits –
Critical limits are tolerances beyond which the related CCP is out of
control and a potential hazard can exist.
A critical limit is a maximum and/or minimum value at which control
must be maintained for the CCP.
e.g. : Temperature/ Time, pH, salt concentration etc.
Dr. Hany Khalil, Professor of food science, California state university, California.
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4. Establish monitoring procedures –
Monitoring is a scheduled observation of a CCP and its
limits.
It Determines;
What will be monitored?
How it will be monitored?
When it will be monitored?
HACCP Plan Form is needed for this step.
18Almond board of California, USA
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5. Establish Corrective Action –
When there is deviation from an established CCP, corrective actions
must be taken to prevent a product that may be unsafe from reaching
consumers.
Corrective action steps taken must be documented.
Dr. Hany Khalil, Professor of food science, California state university, California.
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6. Establish Verification Procedures –
Every HACCP plan should be examined to validate its ability
to control food safety hazards that are reasonably likely to
occur, and that the plan is being effectively implemented.
CCP verification;
# Are we doing the right thing ?
# Do we do what we say ?
# Do we say what we do ?
Dr. Hany Khalil, Professor of food science, California state university, California.
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7. Establish Record keeping and Documentation –The HACCP plan must be on file at the facility.
Types of records could include:Processing records.Deviation records.Product safety records.Ingredients, ingredient certification, supplier qualification.Storage and distribution.
Dr. Hany Khalil, Professor of food science, California state university, California.
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Advantages
Enhances food safety management.
HACCP can be applied throughout the food chain.
Allows more efficient and effective use of resources.
Cost effectiveness.
Can help identify process improvements & reduced customer
complaints.
International Acceptance.
Enhances customer satisfaction / reduces dissatisfaction
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HACCP certified firms
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Conclusion
HACCP is a powerful tool in food safety management.
Ensuring food safety in industry.
It takes consistent, steady, and diligent effort to constantly
think about process/product and be ready to implement
changes to enhance food safety.
HACCP system can also be used in areas other than food
industry where product safety and purity is prime concern.
e.g. Pharmaceutical Industries
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References: -
1. www.usda.gov
2. www.haccp-international.com
3. www.haccpindia.org
4. Dr. Hany Khalil, Professor of food science, California state
university, California.
5. Almond Board of California, USA.
Thank You…!!!
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Group of pharmaceutical professional bonded together to form GAMP®
It’s a guideline not a regulation
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History and Evolution of GAMP®
Founded in 1991 in the UK
First GAMP® published in march 1995 and
partnered with ISPE®
Second GAMP® published in May 1996
Third GAMP® May 1998 Fourth GAMP® December 2001 Fifth GAMP® February 2008
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* GAMP Organization:
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ICH guidelines
• Q8-Pharmaceutical development• Q9 -Quality risk management• Q10- Pharmaceutical quality system
FDA (Good management practices)
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Why GAMP® useful now?
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Software Categories According to GAMP® Classes
GAMP Class Category Validation Action1 Operating System Record Version2 Instrument And
ControllersRecord
Configuration and calibration
3 Configurable Packages
Audit Supplier, Apply full life cycle
requirement
Table no:-1 Software categories according to GAMP® classes
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Hardware Categories According to GAMP® Classes
Sr.no Hardware category Name of category
A 1 Standard Hardware Component
B 2 Custom Built Hardware Component
Table no:-2 Hardware categories according to GAMP® classes
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Universal Approach
Applies to all type of system
Process control system
Spreadsheet
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Uniform Approach
‘V’ model is universally applicable
Plan >Check>Do>Record
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The ‘V’ Model
Fig:-1 The ‘V’ model
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Five key concept of GAMP®
Product and process understanding
Lifecycle approach within QMS
Scalable life cycle activities
Science based Quality Risk Management
Leveraging supplier involvement
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Using GAMP to Validate Continuous Monitoring System Software
Ten step process
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1) Develop URS• SMART
2) Begin building a traceability matrix• Track the requirement listed in the URS• Verify the function
3) Audit vendor and select the product• Audit and examine facility
4) Determine the software type• Off the shelf• Configured• Custom
5) Develop functions specification document• Describe the function of software and fulfill the requirement of the URS
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6)Develop detailed specification document• Perform the specification as per FS
7)Develop testing document• necessary for all the categories of the system
8)Finalise traceability matrix• time to do final check
9) Run system test• all tested the check list
10)Maintain the system under change control• GAMP approach is a lifecycle approach which
means maintaining system untill retirement
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Key maintenance step for any Automated System
SOP’S
Training
Calibration
Validation
Change control (any changed are introduced in a
controlled manner)
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Applications
Monitoring manufacturing, production and storage
environments in the pharmaceutical industry.
Monitoring the autoclaving process in the pharmaceutical
industry.
Water purification in the pharmaceutical industry.
Freeze drying in the pharmaceutical industry
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Conclusion
While there are new revolutionary concept in GAMP 5,it does
bring together the latest industry and regulatory thinking GxP
computerized system validation into one concise guidance.
Regulatory companies can reduced the time and cost necessary
for validation and maintain their system in a compliant state.
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References
Kelvin C. Martin, Risk Based Validation –The Benefits of the GAMP
Approach, Engineering Pharmaceutical Innovation ISPE,2012
GAMP 5-A brief overview ,IFF mode 2012-09-19
Keith williams,GAMP5 as suitable framework for validation of
Electronic Document Management System ‘On Premise’ and ‘in the
Cloud’
Danilio Maruccia, GAMP Guideline & Validation
Document,PQE,2006
Maas & Peither AG-GMP Publishing, The ‘v’ Model logprofile no
16 ,2012,1-3
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Thank You