Quality System Gap Assessment:

Why is it needed and what are the benefits?

April 19, 2021 – (SPARTA, NJ) – Gap Assessments are a standard in the Life Sciences Industry
and are utilized by all size companies as a quality control and compliance mechanism. The
results of the assessment and the recommendations it produces ensure that the Quality System
program works in accordance with established rules and regulating body standards.

The Gap Assessment should be viewed as a tool to assess the company’s in-house quality
management system and current compliance level, according to Nick Andrews, Director of
Operations at Medvacon. “A Quality System GAP Assessment is conducted to ascertain the
status, validity, and reliability of quality information and provides an assessment of the internal
controls of the Quality System,” he explains. “In simple terms it is the inspection of the Quality
System to ensure that it meets the requirements of its intended use and expectations/standards of
regulating bodies, such as the US FDA.”

A company that produces pharmaceutical products must be able to demonstrate that it does so
with absolute reliability, in optimal conditions, and with extreme uniformity that allows accurate
reproduction. “The GAP Assessment is a means for assessing compliance with the established
objectives defined in the quality system and paves the way for a continuous improvement program
by providing feedback to management,” according to Andrews.

With Medvacon, some of the areas that will be reviewed during a GAP Assessment are derived
from the FDA Guidance ICH Q10 – Effective Pharmaceutical Quality Systems. Andrews says
they include pharmaceutical development, technology transfer, commercial manufacturing, distribution
(excluding wholesaler activities), and product discontinuation.

Medvacon is a full-service Quality and Compliance consulting firm offering a suite of quality
services such as: Quality Systems Implementation and Remediation; Computer System
Validation; Process and Cleaning Validation; Equipment, Facility and Utility Qualification;
Mock FDA Inspections and Audits; Project Management; and cGMP Training. These services
help clients to ensure FDA Compliance and reduce compliance cost in the Life Sciences’
industry. The company provides experienced project administration, trouble-shooting, and/or
training services, on-site, with local resources and senior management involvement to optimize
flow and collaboration. Headquartered in Sparta, NJ, Medvacon also has offices in San Diego
California. More information can be found at http://www.Medvacon.com.


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