Auditing of microbiology laboratory

introduction About The Audits Of microbiological Laboretories

1. Auditing Of Microbiology laboratory By Nikita Bajarang Amane M Pharmacy 1 st 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