Today, FDA Investigators don’t just pore over your documents, they access your computer-based systems to obtain your information directly! The old way of managing FDA Inspections, while still valid, needs to be updated. This White Paper looks at traditional FDA Inspection approaches, the new “live review” approach, impacts from the “live review” approach, and how to best adapt to the “live review” approach. Anyone involved in FDA inspections needs to read and understand this material, and determine how best to be prepared for this within their organization.
This White Paper provides an in-depth review of contemporary capabilities and solutions for effectively integrating third-party CMOs and other suppliers with GMP manufacturing quality systems and operations. It explores problems with quality oversight in the third party supply chain; how to think differently about managing the third-party supply chain; considering a technology framework to support improved third-party supply chain effectiveness; and how to “make it happen” for your company. This White Paper will stimulate your thinking and engage readers with questions about changing the game with people-process-technology third party supply chain approaches.
FDA’s June 2013 Guidance for Industry, Cosmetic Good Manufacturing Practices, has outlined FDA’s thinking and expectations surrounding the quality and control approaches to the manufacture of cosmetic products for the US Market.
The Guidance incorporates principles of ISO 22716 as part of the international harmonization effort with the International Cooperation on Cosmetic Regulations and:
- Addresses raw material standards such as water and color additives;
- Lists prohibited cosmetic ingredients;
- Adds internal audit section requiring regular and demand audits to anticipate problems and implement corrective action; and
- Expands records section to include documentation of all operations, procedures, deviations from procedures, justifications, instructions (including training), specifications, protocols, reports, methods, precautions, corrections, and other information.
A Business Quality System
To address FDA’s “new” expectations and deliver business operating performance, a company needs to have a “Quality System” in place to drive the business processes and control the operations that will ensure compliance with FDA’s expectations. This White Paper will help you to:
- Understand the basic elements and structure of a Cosmetic Quality System;
- Understand how these elements tie to the FDA’s Guidance on Cosmetic Manufacturing; and
- Develop an implementation plan to ensure success with your quality system development initiative.