Quality Acronyms
Which SOP?
Who does that?
Defining Quality
Blankety-Blank
21 CFR Part 111
100

SOP

What is a Standard Operating Procedure?

100

Controlled documents should be reviewed at a minimum every three years from their effective date.

What is Document Creation, Issuance, Control and Retention?

100

This department maintains an accurate ledger of suppliers and supplier reviews

What is supply chain?

100

Remove dirt, debris and filth

What is clean?

100

A _____ is any objectionable insect or other animal including birds, rodents, flies, mites, and larvae.

What is a pest?

200

FDA

What is the Food and Drug Administration?

200

Pallets shall be clean and in good condition.

What is current Good Manufacturing Practices?

200

This department ensures that lines are cleared and cleaned before running product.

What is packaging?

200

Quality personnel who act to identify and fix defects

What is quality control?

200

The master manufacturing record must include a statement of any intentional _____________ amount of a dietary ingredient.

What is overage?

300

GMP

What is Good Manufacturing Practices?

300

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?

300

This department is directly responsible for all employee training.

What is human resources?

300
Use chemicals to kill microorganisms

What is sanitize?

300

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?

400

HACCP

What is Hazard Analysis and Critical Control Points?

400

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?

400

These two departments ensures that correct labels are ready and available for use in packaging.

What are the warehouse and packaging?

400

Quality personnel who act to prevent defects

What is Quality Assurance?

400

You must assign qualified personnel to ___________ the manufacturing, packaging, labeling, or holding of dietary supplements.

What is supervise?

500

FSMA

What is the Food Safety and Modernization Act?

500

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?

500
This department manages quarantined products.

What is the warehouse?

500

A representative sample of product that is held for a designated period of time.

What is a retain sample OR a reserve sample?

500

The batch manufacturing record must include the actual results obtained during any ___________ operation.

What is monitoring?