X hits on this document

103 views

0 shares

0 downloads

0 comments

34 / 37

Manufacture of sterile medicines – Advanced workshop for SFDA GMP inspectors

Nanjing, November 2009

34 |

Raw Materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing Materials

Sterile API – unacceptable process design!

Huge Grade A/B rooms-poor differential pressures

Masses of pipe work

Redundant equipment

Cracks, crevices, ledges…….

Sterility starts here!

Document info
Document views103
Page views103
Page last viewedFri Dec 09 15:50:29 UTC 2016
Pages37
Paragraphs508
Words2308

Comments