A company interpretation of guidance
VanTsteri’s source article comments on the second edition of a Chinese pharmaceutical GMP guide. It discusses contamination accumulation in ducts and the importance of considering cleanliness during installation and maintenance.
Plan access and maintain integrity
The commentary highlights protecting pre-cleaned equipment before installation, providing appropriate cleaning access and preserving system sealing. Treatment methods also need an assessment of duct and filter materials.
Use a justified maintenance plan
The article discusses periodic and event-driven maintenance, including investigation after contamination. Its suggested intervals are the author’s interpretation, not a universal legal schedule. The actual programme should follow the facility’s risk assessment and applicable requirements.