PIC/S EXPLANATORY NOTES FOR SITE MASTER FILE

Please find the new PIC/S "EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE" - OPEN LINK.

Content for Computer System Validation - ref. to 4.2.3 GMP critical computerised systems
- Description of GMP critical computerised systems (excluding equipment specific Programmable Logic Controllers (PLCs).

February 2011 update: EU GMP attached to Chapter 4 Documentation.