NewswireToday - /newswire/ -
Philadelphia, PA, United States, 2010/10/19 - CIS announced the publication of its white paper on compliance-focused approaches to establishing an efficient, effective and sustainable Corrective Action/Preventative Action (CAPA) system for pharmaceutical manufacturers.
Compliance Implementation Services (CIS), a pharmaceutical compliance consulting firm, announced the publication of its white paper on compliance-focused approaches to establishing an efficient, effective and sustainable Corrective Action/Preventative Action (CAPA) system for pharmaceutical manufacturers.
The white paper — authored by the Global Manufacturing Compliance team at CIS — identifies the need for today’s pharmaceutical manufacturers to focus attention on their overall quality and compliance efforts in response to the large number of U.S. Food and Drug Administration (FDA) 483 observations and warning letters citing CAPA deficiencies. The white paper attempts to address the root causes of quality system breakdown and cites guidance from the U.S. FDA, the International Conference on Harmonization Q10 (ICH Q10), and the International Organization for Standardization (ISO).
During a recent CIS webinar, “Manufacturing Best Practices: Establishing and Maintaining a Compliant CAPA System,” one-third (33%) of webinar attendees indicated during an online poll that they were not sure if their companies were implementing a CAPA system robust enough to withstand a regulatory inspection. To address these organizational concerns, the webinar — and the white paper on which it was based — cites specific comments from FDA communications regarding CAPA system deficiencies, and presents three critical elements to assist companies in addressing areas of non-conformance. The white paper not only presents ways to improve manufacturers’ overall quality management systems, but also provides strategies to prevent issues from recurring.
Compliance Implementation Services (CIS) is a consulting firm specializing in compliance strategies for the pharmaceutical industry, from Global Clinical Research and Development, through Manufacturing, U.S. Commercial Compliance, and Government Programs. Founded in 2004, CIS (cis-partners.com) provide its clients with a deep understanding of industry laws and regulations, innovative and practical applications, and custom solutions to establish a “Culture of Compliance” that is both meaningful and sustainable.
CIS experts identify, assess and prioritize an organization’s exposure to compliance risks, subsequently developing and implementing risk evaluation and mitigation techniques to ensure adherence to legal and regulatory requirements.