GMP Standards

EU Good Manufacturing Practice 2014 - Annex 1 Manufacturer of Sterile Medicinal Products gives the standards for which pharmaceutical production areas are to comply to. These inlcude standards for clean rooms and clean air devices.

Testing for GMP units inlcudes:

  • Airbonre particles both at rest and in operation
  • Air flows and air flow patterns
  • Microbial testing
  • Filter integrity (DOP)
  • Clean up rates

 

SQC are able to perform all the tests required by EU GMP.