QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 22

SOP No. QCS-008.00 Effective date: mm/dd/yyyy
Approved by:

8.3.5.4 sampling Points of sterile Plant Wfi (attachment i)

sampling Point
description building activity frequency a

WFI return

WFI supply
WFI return from freeze drier

Each manufacturing day or
at least twice a week

WFI supply for freeze drier
Solution preparation
Washing machine

Sterile plant

Vessels machine (sink)
Clothes washing Twice a week

a It is appropriate to increase or decrease sampling based on the trend performance. The time and date can be
determined according to the activity.

8.3.5.5 Pure steam (attachment ii)

sampling Point
description building activity frequency a

Station

Sterile plant SIP Once a week

SIP

a It is appropriate to increase or decrease sampling based on the trend performance. The time and date can be
determined according to the activity.

8.3.5.6 sampling Points of biotechnology Plant
• The ultrapuriication water system can be sampled each manufacturing day or at least once
weekly.
• Deionized water for washing can be sampled each manufacturing day or at least once
weekly.

8.3.5.7 sampling Points of sterile Plant (di Water)

sampling Point
description building activity frequency a

DI return

Once a week

DI supply
Hand washing

Sterile plant A Washing

Solution preparation
Washing machine

Twice a week

Sink