A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” 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)(317 KB) – e.g. identification and authenticity of products.