ajat presentation food and traceability 30.8.2013 references sources

The sensor makes the difference!


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


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


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


• 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


© 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)


© 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

The sensor makes the difference!© ICH

• 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


https://en.wikipedia.org/wiki/Hazard_analysis_and_critical_control_points

http://www.fda.gov/Food/GuidanceRegulation/HACCP/default.htm

RISKSHAZARDS &

THREATS


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



Pharmaceutical Quality Control

Quality ThreatConformance Threat

Images by InnospeXion©


Medical Product Quality Control

ConformanceThreat



ConformanceThreat

Product Quality Attributes



Critical Quality Attributes

Conformance ThreatForeign Object Threat



Glass Detection in Chocolate




Canned Food Product

Foreign Object Threat



Seal Integrity & Foreign Object Detection


Pathogen Threat



Food in Sealed Package Detection

Pathogen ThreatConformance Threat



Conformance Threat

Natural Cork Quality Control



Packaged Fish Bone Detection




Foreign Object Threat

Foreign Object Detection in Grains


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


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.



Thank You!

[email protected]


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

http://www.fda.gov/Safety/Recalls/default.htm

http://www.fda.gov/Safety/Recalls/default.htm

http://www.cdc.gov/outbreaknet/surveillance_data.html

http://www.cdc.gov/outbreaknet/surveillance_data.html

http://www.phrma.org/counterfeit-drugs

http://www.phrma.org/counterfeit-drugs

http://www.foodwastealliance.org/

http://www.foodwastealliance.org/

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/ucm137175.htm




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

http://www.mygfsi.com/

http://www.mygfsi.com/

http://www.astm.org/COMMITTEE/E55.htm

http://www.ich.org/

http://www.fssc22000.com/

http://www.brcglobalstandards.com/globalstandards/standards/food.aspx

http://www.innospexion.dk/