QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 534

(continue d)

in case of failure respond retest

media
fill
no.

contamination comparison corrective actions yes no result remark

Media fill contaminant same
as routine environmental
contaminant

Increase media fill environmental
monitoring (in the same location) to
confirm the contaminant source.

Sterility test contaminant
same as media fill
environmental contaminant

Increase routine environmental
monitoring (in the same location)
and number of media fill vial to
conform.

Sterility test contaminant
same as routine
environmental contaminant

Sterility test voided.
Investigate sterility test procedures
and room sanitation/sterilization
methods to eliminate cause.

If media fill environmental
contaminant same as
sterility test contaminant
and if routine environmental
contaminant same as
sterility test contaminant

Check environmental monitoring
methods and techniques closely for
problems.
Review personnel practices, gowning,
sanitation, and sterilization.

Media fill environmental
contaminant same as
routine environmental
contaminant

Increases the number of media fills
vial in media fill in order to
determine the product risk potential.
Review monitoring technique for
possible problem.
Review personnel practices, gowning,
sanitation, and sterilization.
Hold the Production
Critical systems (HAVAC, compressed
air/gas, water, steam) should be
reviewed for documented changes.
All HEPA filters in the filling area
should be inspected and rectified, if
warranted.
Training records for all individuals
(production, maintenance, cleaning)
involved in the fill should be
reviewed to assure proper training
was provided.

Final comment:

Tested by: Checked by:

Date: Date:

Distribution:
1. Validation officer, production manager, maintenance engineer
2. In case of failure: QA manager, plant director