current good manufacturing practices (cgmps ... · 1. traditional cgmp requirements; and 2. the...
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© 2016 Venable LLP
November 16, 2016
Current Good Manufacturing Practices (cGMPs): Understanding their Unique
Role in Food Safety Requirements
Claudia Lewis
Partner, Venable LLP
202.344.4359
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AGENDA How CGMPs factor into the scope and authority of the FDA.
Defining CGMPs and their significance in food commercialization.
Changes to food CGMPs under FSMA’s Preventive Controls for Human Food Final Rule.
Examining requirements for qualified individuals.
Deciphering HACCP/ HARPC applicability as per the rule and its relationship with CGMP compliance.
Validation and proofs of preventative controls.
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Current Good Manufacturing Practices (CGMPs)
• Food, Drug, and Cosmetic Act (“FDCA”) provides the basis for regulating manufacturing practices under the adulteration provisions. Food is adulterated if it:
– Has been manufactured under such conditions that it is unfit for consumption. (FDCA § 402(a)(3)); or
– Is prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. (FDCA § 402(a)(4))
• GMP regulations first proposed in 1968
• Finalized GMP regulations under 21 C.F.R. 110 in 1986 applicable to all “food”
• Industry-specific regulations impose additional, specific requirements for certain products (e.g., infant formula, juice, seafood)
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• Requirements under CGMPs are purposefully general• CGMPs for food manufacturing are organized into five
subparts: – General Provisions – Buildings and Facilities – Equipment – Production and Process Controls– Defect Action Levels
• The requirements listed in the CGMPs are minimum standards
• FDA inspections determine whether or not a food manufacturer is in compliance with CGMPs
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• Significant objectionable practices discovered during an inspection can result in various regulatory actions:
– Warning Letters (typically precede more severe penalties)
– Injunctions
– Form the basis for mandatory food recalls
– Civil fines
– Seizures
• Violations of cGMP can result criminal prosecution
– No proof of intent to violate FDCA needed for misdemeanor convictions
– Felony convictions apply in the case of a second violation or intent to defraud or mislead
– Convictions may also result in imprisonment for up to three years
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Consequences of Noncompliance
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Enforcement Example: Roos Food’s Inc.
• Listeria outbreak traced to company’s cheese products
• FDA inspection found numerous violations of cGMPsin their manufacturing facility, including leaky roofs and contaminated surfaces
• FDA revoked company’s food facility registration
• Company and its principals pleaded guilty to criminal misdemeanor
• Court imposed a $100,000 fine
• Principals also agreed to a permanent injunction that sets a very high bar for the re-opening of the fa facility
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FDA Perspective
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CGMPs, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
• The rule was finalized on September 17, 2015 with rolling compliance dates.
• First compliance date: September 19, 2016.
• 21 C.F.R. Part 117 revises and replaces 2 1 C.F.R. Part 110 in its entirety when
• Conceptually 2 categories of requirements under the new Part 117:
1. Traditional CGMP requirements; and
2. The Food Safety Plan, which encompasses the Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirements
• Structure of Part 117:o Subpart A: General Applicability o Subpart B: Current Good Manufacturing Practiceso Subpart C: Hazard Analysis and Risk-Based Preventive Controlso Subpart D: Modified Requirementso Subpart E: Withdrawal of a Qualified Facility Exemption o Subpart F: Requirements Applying to Records that Must be Established and Maintainedo Subpart G: Supply-Chain Program
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Out with the Old in with the New
• 21 C.F.R. Part 117, Subpart B establishes quality control requirements for food facilities to ensure that food is prepared and processed under sanitary conditions.
• Changes from part 110:
– Use the term “allergen cross-contact” to distinguish from unintended allergens that are a result of contamination.
– Contamination of food packaging materials must also be prevented
– Microorganisms include protozoa and microscopic parasites
– Contaminants include radiological hazards
• Biggest change = “qualified individuals.”
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• “Qualified Individual” Every individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) must be a “qualified individual”:
A person who has the education, training, or experience (or combination thereof) necessary to perform the required activity and can read and understand the language of any records that the person must review in performing the activity.
• Qualified individuals must be trained on food safety and hygiene.
• Must maintain training records of qualified individuals.
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The Qualified Individual
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Preventive Controls Qualified Individual
• The Final Rule introduced a new term: “Preventive Controls Qualified Individual” (PCQI)
– A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
• The PCQI must develop or oversee the development and implementation of the food safety plan.
• Job experience or training equivalent to the standardized curriculum recognized as adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training) are sufficient to meet the PCQI qualification requirements.
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The Food Safety Plan
• Food facilities must develop and implement a food safety plan for each food that it manufactures, processes, packages, or holds.
• Elements of food safety plan:
– Hazard analysis;– Preventative controls if required based on the hazard analysis;– Procedures for monitoring and managing preventative controls;– Corrective action procedures; and– Verification procedures
• The food safety plan must be signed and dated by the owner, operator, or agent in charge of the facility when it is completed and whenever it is modified.
• Must also maintain records documenting implementation of the food safety plan.
• No English language requirement for the food safety plan or implementation records.
• The entire food safety plan must be reassessed every 3 years.
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Hazard Analysis
• Requires analyzing all ingredients, processes, and manufacturing steps to identify known or reasonably foreseeable “hazards.”
• Hazard = any biological, chemical (including radiological), or physical agent having the potential to cause illness or injury.
May be naturally occurring, unintentionally introduced, or intentionally introduced for economic gain.
• Identified hazards must then be evaluated to determine the effect, if any, a preventive control might have.
• If preventive controls are not required, the food safety plan will only consist of the hazard analysis.
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Hazards Requiring a Preventive Control
• Applies to known or reasonably foreseeable hazards
• Consider:
– Severity of the illness or injury if hazard were to occur and probability that hazard will occur without preventive control
– An evaluation of environmental pathogens when ready-to-eat food is exposed to the environment prior to packaging where there is no treatment or other control measure that would significantly minimize the pathogen
– Specific factors such as formulation of food, facility & equipment, raw materials, transportation, processing conditions, intended use, sanitation, natural toxin levels
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Risk-Based Preventive Controls
For each hazard identified as requiring a control, the PCQI must develop and implement controls under one of the following approaches, which may or may not involve critical control points:1. Supply-chain controls (verification of suppliers)2. Food allergen controls (labeling and controls to prevent cross-contact)3. Sanitation controls (preventing contamination with microbial pathogens)4. Process controls (acidification, filtering, pasteurization)5. Recall Plans (mandatory)
A facility is not required to implement preventive controls if:• You determine and document that the type of food (e.g., raw agricultural commodities
such as cocoa beans, coffee, grains) could not be consumed without application of an appropriate control; or
• You delegate the preventive control to a downstream customer and have appropriate documentation.
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• More than one hazard may be controlled by the same process.
• Must have a recall plan for each hazard requiring a preventive control including procedures for:
– Notifying direct consignee
– Notifying the public
– Conducting effectiveness checks
– Disposing of recalled food
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Risk-Based Preventive Controls
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HARPC vs. HACCP: What’s the Difference?
• Hazard Analysis and Critical Control Points (HACCP) is a food safety strategy required for seafood, juice, meat, and poultry.
• Only manufacturers that are required to comply with FDA’s HACCP regulations under 21 C.F.R. Parts 123 (juice) or 120 (seafood) are exempt from the HARPC-based food safety plan requirements under Part 117.
• Existing HACCP programs that have been implemented as a best practice for other foods may be used to develop a HARPC-based food safety plan under the new Part 117, but it is not a complete substitute.
• Major differences (summarized on the next slide):
• Preventive controls under HARPC are broader – not limited to process-related controls with maximum/minimum values only at critical control points (CCPs). For example, HARPC preventive controls may include supplier and food allergen controls.
• Monitoring at every CCP under HACCP plans, but not under HARPC.• HARPC more flexible in what constitutes an appropriate corrective action.• Recall plans required under HARPC.
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This comparison chart was developed by FDA in the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, available here.
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Monitoring
• The food safety plan must include written monitoring procedures as appropriate to the nature of the preventive control and its role in the food safety system.
• When developing the plan, consider:1. What will be monitored? 2. How will monitoring be done? 3. How often will monitoring be done (frequency)? and 4. Who will do the monitoring?
• Monitoring should occur “often enough that the normal variability in the values you are measuring can be determined and a deviation from normal will be detected.”
• The plan must also include the position of the employee who will conduct the monitoring.
• Monitoring must be documented and verified.
• Example: Process controls would require monitoring parameters to ensure min./max. values
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Corrective Actions and Corrections
• The HARPC rule requires:
– Establishing corrective action procedures as part of the food safety plan;
– Taking corrective actions in the event of anticipated and unanticipated problems;
– Making corrections by identifying and correcting the problem when minor, isolated problems occur that do not directly impact product safety.
• Corrective actions must be taken and documented when unanticipated problems arise.
• Corrective action records must be reviewed (as part of the verification activities) within 7 working days after the records are created or within a reasonable time, provided there is a written justification to support exceeding 7 days.
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Verification Requirements
• Must perform verification activities as appropriate to the nature of the preventive control and its role in the facility’s food safety system.
• Verification includes validation of preventive controls, verifying corrective actions/monitoring, reanalysis of the food safety plan as a whole at least every 3 years.
• Verification of implementation and effectiveness involves:
– Calibration of process monitoring instruments;
– Product testing for hazards;
– Environmental monitoring; and
– Record reviews.
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• Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.
• Some controls do not require validation:– Food allergen controls (human food)
– Sanitation controls
– Recall plan
– Supply-chain program
– Other preventive controls where the preventive controls qualified person prepares written justification for why unnecessary
Validation of Preventive Controls
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The following entities are exempt from the HARPC provisions of the new cGMP/HARPC rule:
• Qualified facilities: defined in terms of food sales volume; subject to modified requirements;
• Activities subject to HACCP requirements under 21 C.F.R. 123 (seafood), HACCP requirements under 21 C.F.R. 120 (juice), and Low-Acid Foods (LACF) requirements under 21 C.F.R. 113;
• Dietary supplement manufacturers required to comply with and are in compliance with 21 C.F.R. 111;
• Farms;
• Low risk activity/food combinations performed by farm mixed-type facilities that are small or very small businesses;
• Alcohol beverage facilities;
• Facilities solely storing non-fruit & vegetable raw agricultural commodities for further distribution/processing; and
• Facilities storing packaged food not exposed to the environment.22
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FSMA Compliance
Compliance Dates:
• Sept. 19, 2016 for large facilities that are not small or very small businesses for cGMP requirements & HARPC.
• Supply-Chain preventive controls compliance dates begin in March 2017.
• FDA is focused on industry engagement through education, training, and technical assistance.
Helpful Resources:
• FDA Webinar: Preventive Controls for Human and Animal Food Final Rules– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461512.htm
• FSMA FAQs– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm
• FSMA Technical Assistance– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
• FSMA Rules and Guidance Documents– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm
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