To define the responsibilities of Microbiology Department.
This procedure is applicable to all personnel working in Microbiology Department.
3. Responsibilities :
Microbiology Person / Designee, Microbiology Head
4. Procedure :
- Strict adherence to approved procedures.
- To ensure Good Laboratory Practices.
- To follow good documentation practices while making entries in Documents & records.
- To ensure data integrity throughout the whole process of analysis & reporting.
- To follow approved specifications and test procedure for analysis.
- To ensure proper sanitation, cleaning and housekeeping in department.
- To ensure availability of adequate media, reagents & other necessary requirements for lab and their timely procurement.
- To record microbiological test results in template and verification of the data before its release.
- To preparation of SOPs, Protocols & Reports for qualification &/or requalification.
- Sampling, analysis and reporting of raw materials, finished products, intermediates, in-process, stability samples, raw water, potable water, process water, purified water , milli Q water, water for injection.
- Disposal of tested samples and used media after analysis
- To perform environment monitoring of the area exposed directly to the product (powder processing area) as per their defined frequency using Settling Plate Count, Surface Examination Test & reporting the results.
- Supervision of sterilization and depyrogenation runs.
- To prepare & maintain trend data for the water analysis, environment monitoring. Drug substance &/or drug product analysis.
- To submit the trend data to QA for the preparation of Annual Product Quality Review (APQR) of Drug Substances &/or Drug Product.
- Preparation of Monthly reports.
- To perform area qualification as when required.
- In case of any abnormalities or out of specification results observed, then immediately report to the head / designee for further necessary actions.
- To assist Microbiology Head /designee for the investigation of any abnormal or out of specification results.
- Documentation of Preparation and sterilization of media
5. Abbreviations :
- QA : Quality Control
- Lab : Laboratory
- SOP : Standard Operating Procedures
- APQR : Annual Product Quality Review
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