This course, the third in a four-part series, has been designed by ISPE and UL EduNeering, in cooperation with the Food and Drug Administration (FDA)/Office of Regulatory Affairs ORA, to assist FDA personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry during Pre-Approval and routine current Good Manufacturing Practices cGMP inspections. The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these systems.
Generally, FDA inspects a pharmaceutical facility for reasons other than the firm’s computer system validation (CSV) program. However, because so many business processes are governed by electronic systems, the topic of CSV inevitably comes up during the course of an inspection.
Because of an increase in the number of federal inspectors, FDA is able to inspect more facilities and dig deeper into areas such as CSV. In recent years, FDA has increasingly cited pharmaceutical firms for issues involving computerized systems The FDA publication Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections (Compliance Program or CP) gives overall guidance on the inspection of drug manufacturing establishments. It specifies that inspections should be “systems-based” and includes a general scheme for inspecting drug/drug product manufacturing systems, including quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control systems. This course addresses the following:
- FDA Guide to Inspection of Computerized Systems in Drug Establishments
- FDA Compliance Program Guidance Manual, Program 7356.002 for FDA Staff: Drug Manufacturing Inspections
- FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application - August 2003
- GAMP5: A Risk-Based Approach to Compliant GxP Computerized Systems, Copyright ISPE 2008
- FDA Guidance for Industry, Process Validation: General Principles and Practices FINAL GUIDANCE - January 2011
- FDA Glossary of Computerized System and Software Development Terminology
- FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Take Back to Your Job:
- Recognize where computerized systems are used in the pharmaceutical manufacturing process.
- Recognize FDA’s approach to inspecting computerized systems.
- Identify the levels of review that may be used and what comprises each level.
Attendance Suggested For:
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
- Computer system vendors or consultants, engineering contractors, and validation service companies.