In October, 2008, PIC/S published a new version of this guide for GMP-inspectors to use during inspections of healthcare establishments which prepare medicinal products for direct supply to patients. See section 4.2 for expectations regarding electronic records and documents. Section 5.2 describes the appropriate use of a validated computerized system for verifying material identity, weight, and volume.
The October, 2008 version of this Guide is a re-issue of the April, 2008 version with a correction to a misprint in paragraph 85 of Annex 1.
