White Papers

The Value of Studying and Utilizing FDA's QSIT Manual

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White Paper 1 The Value of Studying and Utilizing FDA's QSIT Manual Introduction In 1992 the United States entered into the Global Harmonization Initiative, and the Global Harmonization Task Force (GHTF) was formed with representatives from Japan, the European Union, Australia, Canada, and the United States in an effort to harmonize the 1978 Good Manufacturing Practices (cGMP) regulation for the medical device industry with ANSI/ISO/ASQC Q9001-1994– Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and the ISO draft international standard (ISO/DIS 13485). In an effort to encourage FDA to work with foreign countries toward mutual recognition of cGMP requirements and to be as consistent as possible with international standards, the GHTF adopted a step-wise approach toward harmonization, with the establishment of four objectives: Objective #1: The harmonization of quality system requirements with ISO 9001 as a building block of all future work in harmonizing quality system requirements recognized around the world. Current Status of this Objective: Publication of 21 CFR Part 820 – Quality System Regulation (QSR) – October, 1996 Objective #2: Harmonization of regulatory auditing or compliance inspections. Current Status of this Objective: Publication of "Quality System Inspection Techniques" (QSIT) – August, 1999 Objective #3: The harmonization of the policy, interpretation, and regulatory consequences of noncompliance with quality system requirements in the United States, and in counterpart requirements of other countries. Current Status of this Objective: The actualization of this goal is still on-going. Objective #4: The mutual recognition of inspections and utilization of qualified third parties to perform inspections. Current Status of this Objective: On-going negotiation of mutual recognition agreements between all parties. Purpose of This White Paper The purpose of this white paper is to discuss the role and value of the QSIT Manual to Medical Device manufacturers in performing compliance Gap Analysis, conducting Internal Audits, and in preparation for FDA Inspections. What is QSIT QSIT, an acronym for Quality Systems Inspection Technique, is a published guide to Inspections of Quality Systems of Medical Device Manufacturers written to provide guidance to the FDA field staff on the inspectional process that may be

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