SAFC Quality Organization

General Statement

SAFC has optimized the Quality Management, Quality Assurance, and Regulatory Affairs organizations in order to consistently meet the Quality and Regulatory requirements of our customers (both internal and external).

Within this organization, individuals assigned to the functional Quality Management Team have been explicitly identified along with the sites they will support. This functional support will insure there is a mechanism for top-down, and bottom-up communication of Corporate Quality guidelines and policies. It also facilitates the Corporate Quality auditing process of all the various SAFC sites.

Organization & Reporting Structures:

Within SAFC, the global Quality Management structure is responsible for overall leadership of the Quality Management and Regulatory Affairs functions. This includes developing strategies and policies for meeting current industry, customer, and business requirements, as well as insuring that proper resources are allocated to the Quality Management System.

1. SAFC Corporate Quality Policies are developed at a corporate level, by the functional Quality Management Team described above, and then implemented at each of the Quality Units at each site.
2. The Quality Units at each site are independent of production and report up through the overall Quality organization.

Quality Responsibilities

	Qualification and validation activities
	Control of documents
	Batch record review
	Product release
	Investigation of nonconformances
	risk assessment
	Implementation of corrective and preventive actions
	Change control and customer notifications
	Training
	Internal, customer and regulatory audits
	Supplier qualification and audits
	Regulatory review of APIs and cGMP manufactured products
	Review and approval of final and raw material product specifications
	Review and approval of all manufacturing and packaging documents and operating procedures