European Union (EU) issues its revised GMP guidance’s for Production and "Premises and Equipment"
Production and “Premises and Equipment” are chapter 3 and Chapter 5 of good manufacturing practice (GMP) guidance’s for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. EU recently published its revised GMP guidance’s on chapter 3 and chapter 5. The two new documents carry the date 23 January 2015. The reason for revision is to improve the guidance on prevention of cross-contamination and to update procedure of risk assessment system. The new requirements will be valid form 1 June 2015 for new products which are evaluated regarding the manufacture in dedicated or multipurpose facilities for the first time. For products already manufactured in multipurpose facilities the new regulations will be valid from 1 December 2015.