Subparts A & D
All individuals who manufacture, process, pack, or hold food must be this type of individual
What are qualified individuals?
What is the title of Subpart B?
What is Current Good Manufacturing Practice?
A facility that manufactures a product containing peanuts may ensure that the product is properly labeled by implementing this type of preventive control
What is an allergen preventive control or a process preventive control?
Subpart F of Part 117 addresses requirements pertaining to what?
What are records?
The requirements for the supply-chain program apply to which types of facilities?
What are receiving facilities?
All individuals involved with manufacturing, processing, packing, or holding food must receive training in these two subjects as appropriate to the food, facility, and the individual's assigned duties
What are food safety and food hygiene (including employee health and personal hygiene)
Name 2 of the sections of Subpart B
What are: 1) Personnel; 2) Plant and grounds; 3) Sanitary operations; 4) Sanitary facilities and controls; 5) Equipment and utensils; 6) Processes and controls; 7) Warehousing and distribution; 8)Holding and distribution of human food by-products for use as animal food; 9) Defect action levels
Name 4 types of preventive controls specified in the rule (not including "other")
What are: 1) process pc; 2) sanitation pc; 3) allergen pc; 4) supply-chain pc; and 5) recall plan
Records of monitoring and corrective actions must be reviewed by or under the oversight of the PCQI within how many days?
What is 7 working days?
Name the 2 major responsibilities of the receiving facility
What is (1) Approve suppliers. (2) Determine and conduct appropriate supplier verification activities, and satisfy all documentation requirements of this subpart?
Name two types of facilities that may be subject to the modified requirements in Subpart D
What are 1) qualified facilities and 2) facilities solely engaged in the storage of unexposed packaged food, some of which require time/temperature controls for safety
Name two types of entities that are subject to Part 117 but are exempt from Subpart B
What are: 1) Facilities solely engaged in the holding and/or transportation of one or more raw agricultural commodities and 2) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing such as roasting)
This is the maximum or minimum value, or combination of values, to which any biological, chemical or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process preventive control
What is critical limit?
Can a facility refuse a request for official review of records because of privacy concerns?
No. All records required by Part 117 must be made promptly available to an authorized representative of the Secretary of HHS for official review and copying upon oral or written request
Name the three types of supplier verification activities specified in the rule
What are: 1) onsite audits; 2) sampling and testing of the ingredient; 3) review of the supplier's food safety records?
Name 3 types of facilities that are exempt from Subparts C & G of Part 117
What are: 1) Qualified facilities; 2) Juice HACCP; 3) Seafood HACCP; 4) dietary supplements; 5) LACF (micro hazards only); 6) alcoholic beverage facilities
This section is new to the cGMP provisions in Part 117
What is 117.95 Holding and distribution of human food by-products for use as animal food?
Records of refrigeration temperature during storage of food that requires time/temperature control for safety may be affirmative records demonstrating temperature is controlled or these types of records demonstrating loss of temperature control
What are exception records?
This individual must sign and date the food safety plan upon initial completion and upon any modification
Who is the owner, operator, or agent in charge of the facility?
Name three circumstances in which a facility subject to Part 117 would not need a supply-chain program
What are: 1) facility is not a receiving facility (no m/p); 2) there are no hazards requiring a supply-chain-applied control; 3) food is supplied for research or evaluation use and meets conditions in 117.405(a)(3); 4) facility is controlling the hazard through its own manufacturing/processing
Farms are subject to which subparts of Part 117?
Farms are not subject to Part 117
True or False: If a facility is exempt from Subpart B, it still must comply with the training requirements for its employees in 21 CFR 117.4
False. The training requirements are not applicable to an entity exempt from Subpart B
Name 2 instances (and timeframe) when a firm must conduct a reanalysis of the Food Safety Plan
What are: 1) at least once every 3 years; 2) when changes in activities create potential for a new hazard; 3) when you become aware of a new hazard; 4) after an unanticipated food safety problem; 5) when you discover a PC or the FSP as a whole is ineffective; 6) when FDA determines it is necessary to respond to new hazards and developments in scientific understanding
In general, a facility must keep all records required by this subpart for how long?
If the receiving facility uses a raw material or other ingredient from an unapproved supplier on a temporary basis, what must it do before accepting the ingredient for use?
What is conduct adequate verification activities for that raw material or other ingredient?