AUDITING OF THE MICROBIOLOGY LABORATORY PART1 MICROBIOLOGY AUDIT
AUDITING OF THE MICROBIOLOGY LABORATORY PART-1 MICROBIOLOGY AUDIT & ITS GENERAL CONSIDERATIONS. PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA
LEARNING OUTCOME • After watching this Video lecture we are going to LEARN: • WHAT IS MEANING LABORATORY? OF AUDITING A MICROBIOLOGY • WHAT ARE THE GENERAL FEATURES OF THIS AUDIT? • WHY IT IS IMPORTANT TO HAVE THIS AUDIT?
What is Microbiology Laboratory Audit?
WHAT IS MICROBIOLOGY LABORATORY AUDIT? MICROBIOLOGY LABORATORY AUDITING is the process of checking the process, materials and product to assure that the quality standard and the necessary requirements are maintained to obtain an effective product and the sterility of the product and environment is maintained It is also important to ensure that the laboratory maintains its compliance with the USFDA GMP regulations as well as with the ICH Q 10 guidelines. The Audit process is a means of reviewing the pharmaceutical programs and processes.
Objectives Of Microbiology Laboratory Audit?
Objectives. . The main objectives of auditing a microbiology lab is as follows: • It assures the conformity of a management system with its regulatory requirements. • Checks the quality of the raw materials for media and culture preparation. • Assures that the standards of sterility is being maintained. • Proper auditing helps in determining the flaws and therefore provides opportunities for improvement. • Helps analyzing the possible risks related to the process and therefore in finding out solutions to prevent or avoid it.
• Now, please take a pause for 2 minutes to recapitulate the topics we have discussed, and try to answer the following questions: • What do you mean by microbiology laboratory audit? • What are its objectives?
Key Features Of Microbiology Laboratory Audit
Key Features Of Microbiology Lab Audit § General Laboratory § Maintenance of Microbiology Equipments § Media Preparation & Storage § Maintenance of Microbiology Culture § Control of Reagent § Sterility Testing, BET Testing & Water Testing § Biological Indicators & Antibiotic Assay § Training of Personnel § Documentation
GENERAL LABORATORY. . § LAB LAYOUT & OPERATION- In microbiology laboratory audit it is very important to check the layout, design and spacing of the laboratory. This helps us assure that the proper sterility can be maintained and contamination is avoided. § It is important to check the air flow pattern inside the premises to assure unidirectional air flow. § Review the cleaning and sanitization schedules, environmental monitoring programs, and respective procedures. § Review the HVAC, LAF & Room Qualification.
MAINTENANCE OF LABORATORY EQUIPMENTS • Review the procedures & documentation for operation, cleaning, qualification, validation, maintenance & control related to autoclaves, incubators, refrigerators & automated isolating systems. • Review logs & investigation of failed operating cycles, & disposition of the contents of failed cycles. • Check for the alarm systems and the methods for handling alarming situations. • Review the reports of change controls and cause of repairs.
• IN THE NEXT VIDEO WE ARE GOING TO LEARN ABOUT § THE OTHER KEY FEATURES OF MICROBIOLOGY LABORATORY AUDIT § THE DOCUMENTS TO BE KEPT IN THIS AUDIT.
Prepared by: Ms. Snigdha Baag Ms. Riya Banerjee Dr. Kishanta K. Pradhan Dr. Manik Ghosh PHARMACEUTICAL QUALITY ASSURANCE DEPARTMENT OF PHARMACEUTICAL SCIENCES & TECHNOLOGY BIRLA INSTITUTE OF TECHNOLOGY, MESRA
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