SOP
What is a Standard Operating Procedure?
Controlled documents should be reviewed at a minimum every three years from their effective date.
What is Document Creation, Issuance, Control and Retention?
This department maintains an accurate ledger of suppliers and supplier reviews
What is supply chain?
Remove dirt, debris and filth
What is clean?
A _____ is any objectionable insect or other animal including birds, rodents, flies, mites, and larvae.
What is a pest?
FDA
What is the Food and Drug Administration?
Pallets shall be clean and in good condition.
What is current Good Manufacturing Practices?
This department ensures that lines are cleared and cleaned before running product.
What is packaging?
Quality personnel who act to identify and fix defects
What is quality control?
The master manufacturing record must include a statement of any intentional _____________ amount of a dietary ingredient.
What is overage?
GMP
What is Good Manufacturing Practices?
The initiator should supply all information required, including a risk assessment that addresses how the change will affect quality, safety, inventory and finance.
What is Deviation Procedure?
This department is directly responsible for all employee training.
What is human resources?
What is sanitize?
You must identify and use an appropriate scientifically valid method for each established ___________ for which testing or examination is required to determine whether the ___________ is met.
What is specification?
HACCP
What is Hazard Analysis and Critical Control Points?
The initiator should supply all information required, including a risk assessment that addresses how the change will affect quality, safety, inventory and finance.
What is Material Qualification, Sampling and Testing?
These two departments ensures that correct labels are ready and available for use in packaging.
What are the warehouse and packaging?
Quality personnel who act to prevent defects
What is Quality Assurance?
You must assign qualified personnel to ___________ the manufacturing, packaging, labeling, or holding of dietary supplements.
What is supervise?
FSMA
What is the Food Safety and Modernization Act?
After all documents are completed, reviewed, and compiled they should be given to the Quality Unit for final review, release, and retention.
What is Good Documentation Practices?
What is the warehouse?
A representative sample of product that is held for a designated period of time.
What is a retain sample OR a reserve sample?
The batch manufacturing record must include the actual results obtained during any ___________ operation.
What is monitoring?