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microbiological audit performed in pharmaceutical industry
- 1. Microbiology Laboratory Audit Presented by :Ram Gulumkar Guided by : Dr. Varsha Jadhav Bharati vidyapeeth college of pharmacy, Navi Mumbai.
- 2. Here’s what you’llfind in this Presentation ● Microbilogical evaluation of water ● Raw material ● Environmental monitoring ● Microbiological monitoring of product Contents of This Template
- 3. Water Testing The microbiologylaboratory will typically have a defined schedule for sampling and testing of both pharmaceutical grade water, from both process control points and from user outlets.
- 4. Sampling Procedure It should describethe way by which water is sampled, such as the volumes required or the need to sanitize an outlet and/or to fit a hose prior to sampling
- 5. —WHO Guideline Water used inmicrobiology laboratory as purified water should be qualified as per WHO norms with an ongoing phase 3 testing all across the entire year which will include both MLT (Microbial Limit Test ) and BET (Bacterial Endotoxin Test)
- 6. Audit Questions andChecklist Questions Checklist ● How are water samples drawn ? ● What is the flush time and what is this based upon ? ● Does a sample record contain a time sample is taken, sampler's name, sample site, time sample delivered to laboratory? ● Is the expiration date on those stored water sampling bottles supported by a study (or any data) ? ● What is the number of hours that may elapse between sampling and BET, is the actual time or hour of sampling recorded along with date ● Asses the method of bioburden testing, whether this is by membrane filtration or by pour plate. ● The selection of culture medium, if not set out in compendia, must be justified, along with the volume of sample tested and the incubation conditions ● Evidence of trend analysis should be available to demonstrate the water system is in control.
- 7. How to PreventBacterial Diseases Raw Material Testing ● Purity, identity and quality of raw materials. ● Refer to USP monographs and perform analytical tests like HPLC, GC-MS, pH etc. ● Take help of microbiology labs.
- 8. Environmental Monitoring Air flowMonitoring Particle counting, active air sampling, UDAF Recovery studies Although environmental monitoring methods cannot be 'validated' , the microbiology laboratory should have understanding of limitations of testing. Method Suitability Effect of residual disinfectants Defined procedure Which describes the rationales for different monitoring locations & frequencies. Site microbiologist Considerable local variations Documented procedure Define limits and separate procedures to tackle out of limits.
- 9. Review of environmental monitoringSOPs. 01 If possible to observe environmental sampling 04 Assess that a range of different monitoring techniques is being used 02 Assess the appropriateness of exposure times for settle plates. 05 Procedures that describes where samples are taken 03 Assess types of agars used and incubation conditions. 06
- 10. Microbiological monitoring ofproduct Environment Premises, cleaning, disinfection & hygiene Personnel Equipment Maintenance, qualification, calibration
- 11. References ● MANOHAR POTDAR(2021). Audit and Regulatory Compliance Nirali Prakashan ● WHO
- 12. CREDITS: This presentation templatewas created by Slidesgo, including icons by Flaticon, and infographics & images by Freepik Thanks Please keep this slide for attribution Do you have any questions?