FDA Regulations And Process Validation Considerations

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FDA Regulations and ProcessValidation ConsiderationsNate Anderson, Ph.D.U.S. Food and Drug Administrationnathan.anderson@fda.hhs.gov

Regulatory Agencies

Regulatory Agencies Red Meat– 3% raw– 2% cooked Poultry Egg products

Regulatory Agencies Seafood QualityGrading (Grade A) HACCP QualityManagementProgram Fee Based

Regulatory Agencies Water (drinking andwaste) Pesticides– Antimicrobial– Insects

Regulatory Agencies Additives Pesticides All foods not inspectedby USDA Animal drugs Nutritional labeling Ingredients labeling

Avenues of Compliance Governmental ActsPromulgated RegulationsPoliciesGuidance documents

FD&CDirect/Indirect AdditivesLabels, Standards of IdentityDairy/PMOLACFJuiceSeafood

FDA “Requirements” Federal Food Drug and Cosmetic Act (FFDCA) 21 CFR 110 Current Good ManufacturingPractice in Manufacturing, Packing or HoldingHuman Food

GMP 110.80 Processes and Controls(a) Raw materials and other ingredients.(2) Raw materials and other ingredients shalleither not contain levels of microorganisms thatmay produce food poisoning or other disease inhumans, or they shall be pasteurized orotherwise treated during manufacturingoperations so that they no longer contain levelsthat would cause the product to be adulteratedwithin the meaning of the act.

GMP 110.80 Processes and Controls(b) Manufacturing Operations.(4) Measures such as sterilizing, irradiating,pasteurizing, freezing, refrigerating, controllingpH or controlling aw that are taken to destroy orprevent the growth of undesirablemicroorganisms, particularly those of publichealth significance, shall be adequate under theconditions of manufacture, handling, anddistribution to prevent food from beingadulterated within the meaning of the act.

LACF Regulations Current Good Manufacturing Practice(cGMPs): 21 CFR Part 110 Low-Acid Canned Foods: 21 CFR Part 113 Acidified Foods: 21 CFR Part 114 Emergency Permit Control: 21 CFR Part 108

The regulations. Describe both recommended (should)and required (shall) items. In CFR parts 110, 113 and 114 apply toboth domestic and imported products.

LACF Facility Registration,Filing Forms & Instructions FDA/LACF Registration Coordinator (HFS-617)Center for Food Safety & Applied Nutrition5100 Paint BranchCollege Park, MD 20740 LACF@FDA.HHS.GOVInternet search keywords: FDA LACF

What is pasteurization?“Any process, treatment, or combinationthereof, that is applied to food to reduce themost resistant microorganism(s) of publichealth significance to a level that is not likelyto present a public health risk under normalconditions of distribution and storage.”(NACMCF, 2006)

PMO RegulationsPasteurization is defined in the PMO and 21CFR 1240.61 as:– 145oF for 30 minutes– 161oF for 15 seconds– 191oF for 1 second– 194oF for 0.5 seconds– 201oF for 0.1 seconds– 204oF for 0.05 seconds– 212oF for 0.01 seconds

Juice HACCP120.24(a) – “In order to meet therequirements of subpart A of this part,processors of juice products shall include intheir Hazard Analysis and Critical Control Point(HACCP) plans control measures that willconsistently produce, at a minimum, a 5 log(i.e., 10-5) reduction, for a period at least aslong as the shelf life of the product whenstored under normal and moderate abuseconditions ”

FFDCA: Misbranding under Sec. 403 Section 403(h) A food shall be deemed to bemisbranded as a pasteurized food unless:– A) Subject to a safe process prescribed as“pasteurization” in a regulationContinued .

FFDCA: Misbranding under Sec. 403– B) Subject to a safe process: I) Reasonably likely to destroy organisms of publichealth significance II) Is at least as effective as a process specified byregulation III) Is effective throughout product’s shelf-life whenstored under normal or moderate abuse conditions IV) is documented by notification to the Secretary andnot rejected within 120 days for failure to meet clausesI, II, or III

Irradiation 21 CFR 179 – Irradiation in the production,processing and handling of food– Covers radiation sources, general provisions,ionizing radiation, radiofrequency (andmicrowave), ultraviolet, pulsed light andpetitioned amendments.

Irradiation The use of a source of radiation that does notcomply with our current regulations requiresan amendment to the regulations through thesubmission of a food additive petition– Example: To use higher UV intensities (i.e., 1Wper 5 to 10 ft2) an interested party would have topetition the agency. The 2000 final rule wasspecific for juice products and does not apply toany other foods. The agency encourages early industryconsultation

Food SafetyModernization /default.htmGet FSMA updates by E-mail!

Preventive Controls Rule Preventive Controls Proposed Rule for HumanFood – Final Rule due Aug. 30th, 2015 FSMA exempted LACF with respect tomicrobiological hazards– LACF processors will still have to address physicaland chemical hazards– Acidified and acid foods not exempt—manufacturers of these products will have tocomply with ALL FSMA requirements unless anexemption applies (e.g., Qualified Facility)

FSMA Preventive Controls Facilities are required to conduct a hazard analysis and implementpreventive controls for identified hazards. Preventive controls: risk-based, reasonably appropriate procedures,practices, and processes that a person knowledgeable about thesafe manufacturing, processing, packing, or holding of food wouldemploy to significantly minimize or prevent the hazards identified inthe hazard analysis and that are consistent with the currentscientific understanding of safe food manufacturing, processing,packing, or holding at the time of the analysis.

Specific Requirements (Proposed) Identify and evaluate hazards Implement preventive controls for the hazards Monitor and verify preventive controls andtake corrective actions if not properlyimplemented Keep records of these activitiesFood Safety Plan

Preventive Controls Preventive controls should be implementedwhen pathogens in foods pose a risk.“identify and evaluate known or reasonablyforeseeable hazards” (FSMA, Sec. 418b) Preventive controls will need to be validated. Pasteurization requires [FFDCA 403(h)]submission of a notification to FDA with thedata.

What is validation? Validation is the collection and evaluation ofscientific and technical information todetermine if the treatment when properlyapplied, will effectively control the hazard.National Advisory Committee on Microbial Criteria for Foods – PasteurizationJ. of Food Protection, Vol 69, No. 5, 2006, 1190-1216

Why do we need to validate? To establish documented evidence thatprovides a high degree of assurance that aspecific process or system will consistentlyproduce a product meeting its predeterminedspecifications and quality attributes.Adapted from NFPA Bulletin 43-L

Validation Studies Are needed for process technologies implemented aspreventive controls for pathogen reduction in foods For equipment operating within its establishedcontrol limits, microbiological validation providesdocumented evidence that the process deliversmicrobiological inactivation to predefined,acceptable and safe levels.

Validation within FSMA The validation of preventive controls:(1) Must be performed or overseen by a qualified individual(2) Must include collecting and evaluating scientific andtechnical information (or conducting studies) to determinewhether the preventive controls, when properly implemented,will effectively control the hazards that are reasonably likely tooccurHuman food: 21 CFR 117.150 (a)(1), (a)(2)Animal food: 21 CFR 507.45 (a)(1), (a)(2)

Approaches to validation Government guidanceSafe harborsPublished scientific literatureMathematical modelsData from previous studiesData from new scientific experimentsAny combination of these approaches

Validation of Control Measures Use available scientific guidance for validation.

Validation Studies Define the test methodology that will be used forthe process, may be technology & decontaminationprocess specific.Identify the target organism for each specificproduct and process and establish the desired logcount reduction.Calibrate the resistance of the surrogate againstthe target pathogen for each specific product andprocess.Develop a suitable inoculation method andappropriate load.

Validation Studies Challenge the locations in the process and food matrixwhere treatment dose is expected to be lowest—”coldspot”.Sample sufficient amounts of product to haveconfidence in the resultsReplicate validation experiments to establishconfidence in process deliveryIt is useful to “test to failure.”– Understand the boundaries between inactivation and survival– Provide information for deviation evaluation Make appropriate considerations for culture media,incubation temperature, etc.

Validation Studies Determine the appropriate critical factors,limits and design specifications for thedesired process.Critical factors may include:–––––physical (e.g., time, piping design)chemical (e.g., sterilant concentration)mechanical (e.g., conveyor speed)thermal (e.g., temperature, specific heat)radiation (e.g., electromagnetic, photonic).

Considerations for Worst-Case Scenarios Critical factors should reflect the “worst case”expected operating conditions.–––––––Min/Max values for the control measurePermitted manual operationsInteractions between multiple control measuresLoading and speed of conveying systemsMotion of conveying systemsHot and cold starts, ramp-up and ramp-downEquipment wear that can impact critical parameters

Criteria for Evaluation A system that meets all of the regulatoryrequirements specified in the FD&C Act, FSMAand pertinent regulations FSMA requires preventive controls to beimplemented and validated.– Pasteurization requires submission of anotification to FDA with the data. [FFDCA 403(h)]

Criteria for Evaluation An appropriate risk assessment of the processwith an agreed target level ofcontrol/reduction – is the treatment sufficientto prevent illness? Validation must be based on the mostresistant microorganisms of public healthsignificance relevant to the food and theprocess.

Criteria for Evaluation Able to effectively control the hazard (meetspecifications) Scientific evidence that the process is capableof consistent treatment with a high degree ofassurance Determination that treatment is effective forat least as long as the shelf-life of the food

Criteria for Evaluation Complete documentation of the processincluding a description of the system, list ofcritical factors, results from biological test, andlist of factors monitored and recorded Programs are needed to verify that theprocess is operating within specific limits

Food –Final Rule due Aug. 30th, 2015 FSMA exempted LACF with respect to microbiological hazards –LACF processors will still have to address physical and chemical hazards –Acidified and acid foods not exempt— manufacturers of these products will have to comply with ALL FSMA requ

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