Good Manufacturing Practice computer validation

GOOD MANUFACTURING PRACTICE REGULATIONS RELATED TO COMPUTER SYSTEMS VALIDATION... 

Koelman, E., De Jong, K., and Piket. K. (2000), Maintenance and Support of Validated IT Systems, in Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers (Ed. G. Wingate), Interpharm Press, Buffalo Grove, IE. 

Wingate, G.A.S. (2000), Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers, Interpharm Press, Buffalo, IL. 

Software and computer systems used in analytical laboratories that must comply with good laboratory practice (GLP) and good manufacturing practice (GMP) regulations require formal validation to confirm that they meet the criteria for intended use. Both new and existing systems, regardless of age, must be validated for their suitability for indented use. Whereas the first three articles in this series [1-3] focused on validation during development, vendor qualification, and installation and operational qualification of new systems, this article describes the procedures for systems that have been purchased, installed, and used prior to formal validation and that must be newly documented. 

Validating corporate computer systems good IT practice for pharmaceutical manufacturers / editor, Guy Wingate, p. cm. 

Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers provides valuable reference material for pharmaceutical manufacturers, suppliers and regulators on Good IT Practice, validation principles for corporate computer systems and case studies on Electronic Document Management Systems (EDMSs), Enterprise Asset Management (EAM) systems, LlMSs and MRP 11 systems. 

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

The control system of the freeze-drying unit provides control, monitoring and documentation of the process. Such a system must be reliable and comply with GM P and GAMP (Good Automation Manufacturing Practice) demands with respect to computer validation. It should be SCADA (Supervisory Control and Data Acquisition) compatible. A possible hardware architecture is shown in Figure 2.55.1. 

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