1.Objective :

 To define the responsibilities of Microbiology Department.

2. Scope:

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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