PIC/S PE 010-4 Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, 03/14

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In March, 2014, 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 4.1 and Annex 3, section 3, for expectations regarding electronic records and documents, including protection from loss and unauthorized changes, audit trails for changes, and readability during the retention period.
• Section 5.2 describes the appropriate use of a validated computerized system for verifying material identity, weight, and volume.