cGMP Requirements for Pharmaceutical Packaging Machinery
What current Good Manufacturing Practices actually demand from your packaging equipment — materials, design, documentation and cleaning.
If you supply regulated markets, your packaging machinery must comply with cGMP. Here is what that means in practice for machine buyers.
Contact parts and materials
All product contact parts should be AISI 316 stainless steel (AISI 304 for non-contact structures), with food-grade seals and hoses. Surfaces must be crevice-free and polished for easy cleaning.
Design for cleanability
- Tool-free removal of change parts
- Drainable surfaces with no dead legs
- Enclosed guards that still allow visual inspection
Documentation matters
A cGMP machine comes with a documentation package: material certificates, FAT/SAT protocols, IQ/OQ support and calibration certificates for critical instruments. Ask for these upfront — retrofitting documentation is painful.
Audit-ready from day one
Regulators audit your equipment history. Machines from an established manufacturer with proper documentation make those audits routine instead of stressful.
Need help choosing the right machine?
Our engineers will recommend the right configuration for your product, bottles and output.
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