Drug & Device GMP Desk Reference Set

International GMP Master Guide

Specifically designed for Drug Manufacturers, with over 900 pages of GMP Guidance and Regulations to ensure your compliance is up to date! Includes US, EU, ICH, Can. & Japanese Guidance and Regulations.

• All of the US Drug GMP Regulations
• European GMP Regulations
• ICH Q7, 8, 9 and 10 Guidance
• Canadian GMPs GUI-0001 2018
• Auditor's Checklist Parts 11, 211 & ICH Q7
• Japanese GMPs
• Added Chinese GMPs Decree 79 (English)

Medical Device Master GMP Guide

Specifically designed for Device Manufacturers, with over 900 Pages of Guidance and Regulations for the Medical Device Industry Medical Device Manual - Includes US and EU Regulations.

• All of the US Medical Device Regulations
• Quality System Inspection Technique (QSIT)
• PMA/510k Guidance
• New EU MDR 2017/745 Regulations
• Added QSR Auditor Checklist with ISO 13485 References