GPD countdown – coming into operation on 8 September 2013

A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Usepdf” was published in the EU Official Journal and will come into operation on 8 September 2013.

Read more on the new designed EMA website: EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines

CCS executed several GDP assessments for our customers:

  • GDP compliance check and verification
  • GDP assessments including Quality Risk Management, Contract Management, and Operations
  • Validation and Qualification of processes, equipment, and computerized systems
  • Verification of documentation and records management processes
  • Storage and compliance processes

Also note the new Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2013)pdf(317 KB) – e.g. identification and authenticity of products.