Applying GMP to Computerization in a Solid-Oral-Dosage-form-Factory

Abstract

Quality Assurance and Pharmaceutical security as well must be given a particular consideration both for hardware and software when computerized pharmaceutical industrial operations are concernedHardware: The preparation of validation should begin with the design of a computerized system and rely upon specifications and upon defined operational limitsIt is suitable to prepare documentation as from the development of the system in order to obtain a fruitful communication between all those concerned with design, implementation, maintenance, validation and auditingA revalidation procedure should be prepared and maintained updated, in the event of a change in one or several operating conditionsSoftware: As with hardware, validation of software should be envisioned as early as the development phase. Preparation of test procedures and documentation should start at this very stage. Qualification and validation will be designed to find errors in the program and not to prove that no errors exist. They will be carried out at the operational boundaries of the software and will aim at testing the critical decision paths of the program. Verifications must be repeated a sufficient number of times to demonstrate that the results are repeatableAs with other pharmaceutical manufacturing systems, a formal procedure should exist to support changes made to the software. Vendor supplied software should be verified and documented with the same rigour and details that in-house developed software. Manual back-up systems must be provided for and regularly tested in the event of failure of the automated process. Computerized systems and good manufacturing practices applied to manufacturing of solid oral dosage forms: An application of the above-stated principles is given and illustrated