Environmental Monitoring in Pharmaceuticals Manufacturing in EU

R

ricky07

hi, I am looking to what others do for Environmental monitoring in pharmaceutical manufacture.

1. for Inhaled products, Grade D is expected, and samples are taken weekly or monthly.

2, for tablets, creams, liquids - there are no guidlines, and no environmental monitoring by taking micro samples is required. If samples is needed what is frequency?

please let me know your views.

thanks
 

Ajit Basrur

Leader
Admin
All Grade D environments can have once/week.

Refer to this great presentation by James Agalloco, an authority on Environmental Monitoring - PDA Presentation
.
 

Attachments

  • USP-Guidances-on-Environmental-Control-Including-related-USP-FDA-EMEA-PDA-Activities.pdf
    893 KB · Views: 283
Top Bottom