QCS-008 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 19

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

8.3.3 Qa d ePartment

8.3.3.1 Qa manager
The QA manager will review the data and will also follow them up with the corrective actions rec-
ommended in the reports.

8.3.3.2 Qa director
QA director will recommend the remedial actions for OOS results.

8.3.4 t raining
A formal personnel training program is required to minimize the risk of false-positive or false-
negative results.
The training should include at least

• Instructions on the basic principles of aseptic technique
• Good sampling practices
• Demonstration of water system and its potential sources of contamination
• Instructions on the basic principles of microbiology, microbial physiology, disinfection,
sanitation, media selection, media preparation, taxonomy, and sterilization as required by
the nature of personnel involvement in aseptic processing
• Endotoxin basics, sources, and determination

8.3.4.1 supervisor
• Personnel involved in microbial identiication will require specialized training on required
laboratory methods.
• Additional training on the management of the water data collected.
• Knowledge and understanding of applicable operating procedures, especially those relat-
ing to corrective measures that are taken when an adverse drift in microbiological condi-
tions are detected.
• Understanding of regulatory compliance policies and each individual's responsibilities
with respect to good manufacturing practices (GMP) should be an integral part of the
training program as well as training in conducting investigations and in analyzing data.

8.3.5 S amPling
8.3.5.1 Preparation of the sampling bottles
Wash the bottles carefully with water for injection (WFI)

• WFI sampling bottles: The samples are collected in bottles with caps depyrogenated at
250°C/30 min.
• Purified water sampling bottles: The samples are collected in autoclavable wide-mouthed
bottles with stoppers. Glass or polypropylene bottles may be used. Sterilize the bottle at
180°C/1 h (dry heat) or autoclave at 121°C/15 min.

8.3.5.2 sample size
The size of the samples should be sufficient for all required tests, but not less than 100 mL/sample.