QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 32

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

(continued)

type of Water alert limit action limit

Purified water used for
washing and lab usage

≤25 CFU/mL ≤100 CFU/mL

Pseudomonas : absence in 1 mL

R.O. water
Feed water
Drinking water

NA Total viable count : ≤500 CFU/

mL
Coliform : absence in 100 mL
Pseudomonas : absence in 1 mL
Faecal streptococci : absence in
1 mL

The data recovered from the sampling is reviewed for conformance to specifications. Maintenance
and production management are notified immediately when action levels are exceeded. Results
which are over action level (OALs) cause initiation of an investigation to identify the source of the
contaminant. Bacteria which are recovered are identified to genus whenever possible. Sampling
may be carried out more frequently during the investigation or until counts fall back within limits.
System sanitization will also be carried out. The specifications for monitoring of water for injection
are defined in manufacturing site SOP.

8.3.11 i interPretation of d ata
Since microbiological test results from a water system are not usually obtained until after the drug
product is manufactured, results exceeding limits can be reviewed with regard to the drug product
formulated from such water. Consideration with regard to the further processing or release of such a
product will be dependent upon the specific contaminant, the process, and the end use of the prod-
uct. Such situations are usually evaluated on a case-by-case basis.

8.3.11.1 corrective action
As per the attached flowchart (Attachments A and B for excursions of WFI and DI water): When
action limits are exceeded the QA manager will investigate the cause of the problem, take action to
correct the problem, and assess the impact of the microbial contamination on products manufac-
tured with the water and document the results of their investigation.
In addition to reviewing test results, summary data, investigation reports, and other data, the
print of the system should be reviewed when conducting the actual physical inspection. As pointed
out, an accurate description and print of the system is needed in order to demonstrate that the system
is validated.
Maintenance and production management are notified immediately when action levels are
exceeded. Results which are OALs cause initiation of an investigation to identify the source of the
contaminant. Bacteria which are recovered are identified to the genus level whenever possible.
Sampling may be carried out more frequently during the investigation or until counts fall back
within limits. System sanitization will also be carried out.

8.4 reason for revision
First time issued for the ABC Pharmaceutical Company.