GMP Compliance Adviser Update No. 5/2017

With this GMP Compliance Adviser UPDATE you have direct access to all prime regulatory changes and to our GMP expert interpretations. Here are the new features at a glance:

GMP Regulations

C.10 Compilation of Community Procedures on Inspections and Exchange of Information

Conduct of Inspections of Pharmaceutical Manufacturers or Importers

C.10.2 Outline of a Procedure for Co-ordinating the Verification of the GMP Status of Manufacturers in Third Countries
C.10.3 Guideline on Training and Qualifications of GMP Inspectors
C.10.4 Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers, importers and distributors of active substances and manufacturers or importers of excipients used as starting materials
C.10.5 The Issue and Update of GMP Certificates
C.10.6 A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers
C.10.7 Procedure for dealing with serious GMP non-compliance requiring co-ordinated measures to protect public or animal health
C.10.8 Procedure for Dealing with Serious GMP Non-Compliance Information Originating from Third Country Authorities or International Organisations
C.10.9 Guideline on Training and Qualification of Inspectors Performing Inspections of Wholesale Distributors
C.10.10 GDP Inspection Procedure (Medicinal Products for Human Use)
C.10.11 The Issue and Update of GDP Certificates (Medicinal Products for Human Use)