An audit of a microbiology laboratory involves independently reviewing the laboratory's records, operations, and procedures to evaluate efficiency, effectiveness, compliance, and risk mitigation. The objectives are to determine the quality systems in place, the knowledge and capabilities of audited staff, and whether continuous improvement is part of the culture. Principles of efficient auditing include proper preparation, documentation, adherence to methods and standard operating procedures, and staff proficiency demonstrations. Types of audits include those of contract manufacturers, contract laboratories, ingredient suppliers, and internal audits. A micro audit works backwards or forwards from samples to comprehensively evaluate microbiological control. The auditing process consists of planning, on-site information gathering, report preparation, exit meeting,

1. Auditing of microbiology laboratory
Arpit Rajaram Suralkar
M Pharmacy (Quality Assurance)

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