Qualifying your Cleanroom
Technology, manufacturing processes, and regulatory trends have changed in the 10 years since the last revision to Annex 1 of the EU GMP Guideline for the Manufacture of Sterile Medicinal Products. With the revised document set for release this year, the updates significantly impact quality control (QC), quality assurance (QA), and all laboratory activities. This revision is intended to add detail and clarity and provide global alignment of standards. Even though Annex 1 is a European document, drugs manufactured globally for sale in the EU need to comply with the standards, which is why Annex 1 was developed in collaboration with global regulatory bodies such as the World Health Organization and Pharmaceutical Inspection Co-operation Scheme.