SOP Guide for Pharma

SOP for Microscopic Examination

Standard Operating Procedure for Microscopic Examination

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for examining microbial cultures under a microscope in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in microscopic examination procedures within the pharmaceutical manufacturing facility.

Responsibilities

  • Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
  • Microbiologist: Responsible for performing microscopic examination procedures according to the instructions outlined in this SOP.
  • Laboratory Technicians: Responsible for preparing microscope slides and assisting with examination procedures.

Procedure

  1. Preparation of Microscope Slides:
    • Prepare clean microscope slides using appropriate techniques to minimize contamination.
    • Apply a small amount of the microbial sample onto the slide using a sterile pipette or loop.
    • Cover the sample with a coverslip to prevent drying and distortion of the specimen.
  2. Microscopic Examination:
    • Place the prepared slide on the microscope stage and adjust the objective lens to the lowest magnification.
    • Scan the slide to locate areas of interest and adjust the focus as needed.
    • Gradually increase the magnification to observe microbial morphology, motility, and other characteristics.
    • Take note of any observed abnormalities, such as cell shape, size, arrangement, and presence of motility.
  3. Microscopic Analysis:
    • Interpret microscopic findings based on established criteria and reference materials.
    • Record observations accurately and thoroughly in laboratory notebooks or electronic
systems.
  • Consult with senior microbiologists or colleagues for interpretation and verification of findings, if necessary.
  • Cleaning and Maintenance:
    • After examination, clean the microscope thoroughly using appropriate cleaning agents and techniques.
    • Store the microscope in a designated area, ensuring protection from dust and other contaminants.
  • Abbreviations

    • SOP: Standard Operating Procedure
    • QC: Quality Control

    Documents

    • Microscopic Examination Log
    • Laboratory Notebook
    • Reference Materials

    Reference

    United States Pharmacopoeia (USP) General Chapter Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests

    SOP Version

    Version 1.0

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