introduction About The Audits Of microbiological Laboretories

1. Auditing Of Microbiology laboratory
By Nikita Bajarang Amane
M Pharmacy 1st Year
Department Of Quality Assurance
Rajarambapu College Of Pharmacy Kasegaon

2. Introduction
“A service involving an independent review of an
organization's records, operations and procedures
to evaluate for efficiency, effectiveness,
compliance and the existence of adequate internal
controls to mitigate risks to the achievement of the
organization's objectives.”

3. Objectives
1.Determine quality systems in place for
microbiological control
2.Determine level of knowledge and capabilities
of audited site
3.Determine if continuous improvement is part
of culture

4. Six Principles of Efficient Auditing
• Correct preparation
• Correct types and frequencies of QC protocols and
procedures
• Correct documentation
• Adherence to method requirements
• Adherence to SOP procedures
• Initial and continuing proficiency demonstrations

5. Criteria
Process flow and contributing factors
(e.g. intended use of compound , parenterals.
non-sterile)
Monitoring of process
Origin and control of raw ingredients
Water system control and monitoring
Microbial monitoring of ‘product

6. Types of Audits with Evaluation of
Microbiological Control
• Contract manufacture
• Contract microbiology laboratory
• Excipient manufacturer
• Active ingredient manufacturer
• Combination of any of the above
• Internal manufacture or laboratory

7. A Micro Audit
Vertical audits can be more valuable because they
can encompass more ground.
Pick a report and work backwards or pick samples
from the sample receipt stage and work forward.
From a perspective valuable tool to use in
conjunction with the internal audits is the ISO/IEC
17025 Standard.
Another valuable tool (particularly for NATA
accredited laboratories) is the Biological Testing Field
Application Document.
Clause 4.14.1 – ISO/IEC 17025:2005

8. The Auditing Process
Contact auditee
Prepare checklists and plan
Briefing (entry meeting)
Actual audit – information gathering
Preparation of report
Briefing (exit meeting)
Action on findings
Follow up audit if required

9. References
 Auditing Microbiological Laboratories Debra Waller
NJDEP‐Office of Quality Assurance
AUDITING IN THE MICROBIOLOGY LABORATORY
 Microbiology and Auditing Don Singer “ASQ Northeast
Pharmaceutical GMP/Quality Conference 2011”
 Lyndon Thomas Senior Scientific Officer Biological Testing
NATA