cGMPs & Hazards
Preliminary Steps
Hazard Analysis & Preventive Controls
Verification/Validation
Pot Pourri
100
True or false: a parasite is a biological hazard
True
100
Name the 5 preliminary steps
(1) Assemble the food safety team; (2) Describe the product and its distribution; (3) Describe the use and intended consumer; (4) Create a flow diagram; (5) Verify the flow diagram is correct
100
True or False: 21 CFR 117 Requires that you document all sanitation activities
False: Documentation required only for hazards a requiring preventive control
100
Summarize the difference between food safety system verification and validation
Verification = do what you say you are doing in the food safety plan (i.e. in your implementation records, food safety activities) Validation = Make sure what you are doing is effective to control the hazards you have identified
100
When is the compliance deadline small businesses must comply with the Preventive Controls for Human Food rule? (month and year)
September 18, 2017.
200
DAILY DOUBLE: Name 4 types of FDA's "hygienic zones"
Non Manufacturing Areas, Transition Areas, Basic GMP Areas, Primary Pathogen Control Areas, Sensitive/High Hygiene Areas
200
DAILY DOUBLE: True or False: Creating a flow diagram and process summary are required by 21 CFR 117
False. They are useful and recommended, but not required.
200
A firm is processing 2 products, one contains an allergen and the other does not. Provide 3 examples of how the firm can manage the allergen.
GMPs: Run products on separate lines, process in separate areas, run allergen product after non-allergen, good storage practices Preventive Controls: clean up between batches, labeling
200
Name 3 examples of process control validation
FDA guidance, academic studies, challenge studies by an accredited laboratory
200
What is a "small business", as defined by FDA?
A business employing fewer than 500 full-time equivalent employees.
300
Name all 8 major food allergens
Milk, egg, peanut, treenuts, fish, crustacean shellfish, wheat, soy
300
Name 3 at-risk populations to consider when describing intended consumer
Infants, elderly, immuno-compromised, pregnant women
300
What are the 3 main objectives in Hazard Analysis?
Identify hazards, evaluate hazards, determine if hazard requires a preventive control (and at what step that PC will be applied)
300
Name an acceptable form of verifying a supply-chain applied control
3rd party audit, review of food safety records, testing and sampling
300
What is the best way to deal with a leaky handsink? With a prerequisite program or a preventive control?
Water supply and plumbing is addressed by the federal cGMPs and are best addressed by a prerequisite program.
400
Which Subpart of 21 CFR 117 contains the cGMPs?
Subpart B
400
List 3 things you would include in describing a product
Product name, important food safety characteristics, ingredients, packaging type, shelf-life, storage and distribution, allergens
400
What are the 3 management components of a preventive control?
(1) Monitoring, (2) Corrections and Corrective Actions; and (3) Verification *Also important: Critical Limits/parameters
400
Validation is required for...
Process Controls
400
According to the Preventive Controls for Human Food rule, all employees must be trained (and the training documented) on these two topics
Food safety and hygiene
500
If a RTE food is exposed to the environment, what kind of biological hazards must be considered?
Environmental pathogens
500
When assembling the food safety team, must a PCQI be on the team?
Yes. The PCQI may be an outside consultant, but it is recommended that you have a PCQI as a company employee.
500
Name 3 supplier verification activities
(1) Onsite audit, (2) Sampling and testing, (3) Reviewing food safety records for the ingredients, (4) other Must conduct one or more for each hazard that requires that a preventive control
500
Validation is not required for...
Allergen controls, Sanitation Controls, Supply-Chain Applied Controls, Recall Plan.
500
True or False: Sampling and testing as a supplier verification activity may be performed by the supplier
True, provided the receiving facility can review and document review of those records. Sampling and testing may also be performed by the receiving facility or a 3rd party.
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