PT - JOURNAL ARTICLE AU - Susan Vargo AU - Bob Dana AU - Vijaya Rangavajhula AU - Stephan Rönninger TI - A Risk-Based Auditing Process for Pharmaceutical Manufacturers AID - 10.5731/pdajpst.2014.00954 DP - 2014 Mar 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 104--112 VI - 68 IP - 2 4099 - http://journal.pda.org/content/68/2/104.short 4100 - http://journal.pda.org/content/68/2/104.full SO - PDA J Pharm Sci Technol2014 Mar 01; 68 AB - The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. LAY ABSTRACT: Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.