FDA Terminology

Here are some terms and acronyms that you may encounter while investigating or instituting a system that meets the FDA’s standards for quality control and good manufacturing processes.

Audit: A planned and documented investigative evaluation of an item or process to determine its adequacy and compliance with planned arrangements. It evaluates whether these arrangements are implemented effectively and are feasible in achieving the specified objectives.

Audit summary report: A summary of the audit scope and findings.

CAPA: A corrective and preventive action is a concept within good manufacturing practices. CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying which actions need to be taken.

CAR: A corrective action request is an official request for the laboratory to correct a particular process or issue.

CFR Title 21, Part 820: This portion of FDA regulations outlines current good manufacturing practice regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. A copy of this regulation should be available on lab premises.

DHR: The device history record is a compilation of all records pertaining to the production of a finished medical device. It entails extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records, identification labeling, and device identification and lot numbers.

DMR: Section 820.3(j) of the quality system regulation defines device master record as a compilation of records containing the procedures and specifications for a finished device.

GMP: Good manufacturing practices are international guidelines that cover drug and medical device manufacturing to ensure a quality product is produced. They are also known as cGMPs or current good manufacturing practices.

FDA 483: FDA inspectors use this form to detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices.

Monitor: To observe and record activity to measure compliance with a standard of performance, and to collect routine, ongoing data about the indicator.

Non-conformity: Non-fulfillment of a specified or implied requirement of the quality management system or of a quality work product.

Objective evidence: Information, which can be proven true, based on facts obtained through observation, measurement, tests, or other means.

Observation: Objective evidence that creates concern that may indicate future problems.

On-the-spot corrective action: This is an immediate step taken to correct or resolve a non-conformity.

Performance audit: An assessment of the technical activities of personnel, categorized as a quantitative appraisal of quality.

Requirement: A declared, implied, or routine need or expectation.