ajat presentation food and traceability 30.8.2013 references sources
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Kraft Foods voluntarily recalls Jalapeno Variety of Kraft String Cheese with code date of 23 Nov 2012 as a precaution due to the possibility that a thin layer of plastic film from the package may remain adhered to the product. If the film sticks to the cheese and is not removed, it could potentially cause a choking hazard.Winn-Dixie Stores, Inc. (NASDAQ: WINN), is voluntarily recalling Sunrise Assorted Flavor Gummy Bears sold in the self-serve bulk area of select store produce departments between November 14 and December 13 due to a remote possibility of metal contamination.
Ocean Spray added five additional Best By code dates to its voluntary recall issued November 25, 2011 of a limited number of production lots of its Original Flavor Craisins® Dried Cranberries in 5-ounce, 10-ounce and 48-ounce packages in the western U.S. only. Ocean Spray took this precautionary measure due to the possible presence of very small hair-like metal fragments that are unlikely to cause consumer injury. Reference: http://www.fda.gov/Safety/Recalls/default.htm
Horrifying Headlines
About 48 million people get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases: Centers for Disease Control and Prevention CDChttp://www.cdc.gov/foodborneburden/index.html
60 million tons of food waste was generated in the U.S.40 million tons went to landfills.25-40% of the food that is grown, processed and transported in the United States will never be consumed.http://www.foodwastealliance.org/
Counterfeit drugs are a 35-40 Billion US Dollar a year of global business and growing.......http://www.phrma.org/issues/counterfeit-drugs
Scary Statistics
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FDA Food Safety Modernization Act (FSMA) - Increased inspections of foreign facilities
FDA Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach
GFSI Global Food Safety Initiative
Industry Drivers
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ASTM 2500-07 ( 2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. ASTM E55
International Conference on Harmonization (ICH) Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Q9, Quality Risk Management. Q10, Pharma Quality System Food Safety System Certification, FSSC22000 (ISO22000 & PAS223)
British Retail Consortium (BRC) GLOBAL STANDARD FOR FOOD SAFETY ISSUE 6
Industry Standards
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• A planned set of controls, derived from current product and process understanding that assures manufacturing process performance and product quality
• Control strategy derives from management of risk and should lead to assurance of consistent quality of product in alignment with the Quality Target Product Profile (QTPP)
Control Strategy
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© ICH
A system for designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality ( ICH Q8(R2))
Process Analytical Technology (PAT)
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© ICH
• Critical Quality Attribute (CQA): A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality ( ICH Q8(R2))
• Critical Process Parameter (CPP): A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality (ICH Q8(R2))
Product and Process Quality Control
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• HACCP is a systematic preventive approach to food safety and biological , chemical , and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. In this manner, HACCP is referred as the prevention of hazards rather than finished product inspection.
• A systematic approach to the identification, evaluation, and control of food safety hazards.
Hazard analysis and critical control points
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https://en.wikipedia.org/wiki/Hazard_analysis_and_critical_control_points
http://www.fda.gov/Food/GuidanceRegulation/HACCP/default.htm
Foreign Objects: glass, metal, plastic, rubber, stone, bone, etc.
Pathogen: botulism, E. coli, hepatitis A, listeria, norovirus
Conformance: Product does not conform to mandated regulation.
Risks, Hazards & Threats
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Pharmaceutical Quality Control
Quality ThreatConformance Threat
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Medical Product Quality Control
ConformanceThreat
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ConformanceThreat
Product Quality Attributes
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Critical Quality Attributes
Conformance ThreatForeign Object Threat
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Glass Detection in Chocolate
Conformance ThreatForeign Object Threat
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Seal Integrity & Foreign Object Detection
Conformance ThreatForeign Object Threat
Pathogen Threat
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Food in Sealed Package Detection
Pathogen ThreatConformance Threat
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Conformance Threat
Natural Cork Quality Control
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Conformance ThreatForeign Object Threat
Packaged Fish Bone Detection
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Foreign Object Threat
Foreign Object Detection in Grains
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Why to Invest in Process Analytical Technology
Prevent reputational or brand risks Loss of public confidence and trust
Eliminate financial risks Product recall costs Stock market share price costs
Increase profitability Eliminate waste and rework
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Avoid regulatory/compliance risks Fines, penalities, etc.,
Protect your brand by integrating Ajat sensor
technology into your HACCP system.
Demonstrate non-repudiable evidence of product quality
conformance.
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The sensor makes the difference!
FDA Recalls, Market Withdrawals, & Safety Alertshttp://www.fda.gov/Safety/Recalls/default.htm
CDC Foodborne Disease Outbreak Surveillancehttp://www.cdc.gov/outbreaknet/surveillance_data.html
The Counterfeit Drug Problem http://www.phrma.org/counterfeit-drugs
The Food Waste Reduction Alliance (FWRA)http://www.foodwastealliance.org/
FDA Food Safety Modernization Act (FSMA)http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
FDA Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approachhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm137175.htm
References and Sources for more information
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Global Food Safety Initiativehttp://www.mygfsi.com/
ASTM International Committee E55 on Manufacture of Pharmaceutical Products http://www.astm.org/COMMITTEE/E55.htm
International Conference on Harmonisation (ICH)http://www.ich.org/
Foundation for Food Safety Certificationhttp://www.fssc22000.com/
BRC Global Standard for Food Safety Issue 6 http://www.brcglobalstandards.com/globalstandards/standards/food.aspx
Next Generation X-ray Imaging solutions by Innospexion http://www.innospexion.dk/
References and Sources for more information