1.0 Objective

1.1 To lay down the procedure to establish and ensure that the microbiologists working in the Microbiology laboratory are capable of performing the microbial examination of non-sterile products as per the Pharmacopoeia’s method.

2.0 Scope

2.1 Scope of this SOP is applicable for qualification of newly joined microbiologists for routine analysis and periodic re-qualification of microbiologists for performing microbiological tests.

3.0 Responsibility

3.1 Microbiologist shall be responsible for the compliance of this procedure.

4.0 Accountability

4.1 Head/designee – Microbiology shall be responsible for the compliance of this SOP.

5.0 Procedure

5.1 Training Provision

The new joinee shall be provided with “on-the-job training” on:

• Standard operating procedures (SOPs)
• Operation and calibration of instruments
• Microbial analysis of various products

5.2 Pre-Qualification Training

Before qualification, personnel must be trained on:

• Specific instruments and equipment
• Microbial analysis procedures.

5.3 Trainer Qualifications

Training shall be provided by:

• A senior microbiologist experienced in the analytical procedure
• Personnel with validated competency in daily operations

5.4 Practical Training

• Conducted under supervision of a senior microbiologist.
• Includes hands-on practice for microbial enumeration and pathogen testing

5.5 Test Parameters for Validation

Analysts must qualify for one or more of Analysis:

• Microbial enumeration tests:
  • Total Aerobic Microbial Count (TAMC)
  • Total Yeast/Mould Count (TYMC)
• Specified microorganisms:
  • Escherichia coli
  • Salmonella
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Candida albicans
  • Bile-Tolerant Gram-Negative Bacteria

5.6 Qualification Process

1. Step 1: Analyst performs tests on inoculated samples (e.g., buffered sodium chloride peptone solution)
2. Step 2: Identifies deliberately inoculated organisms (must match positive control)
3. Step 3: Colony counts must not exceed a factor of 2 from the inoculated count

5.7 Evaluation & Certification

• If satisfactory: Analyst is qualified (certificate issued by HOD/Disegnee)
• If unsatisfactory: Retraining required before re-evaluation

5.8 Frequency

Requalification every 2 years (or earlier if procedures change)

6.0 Abbreviations

7.0 References

• 8.0 Annexures

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     [Company Logo Here]

     [Your Company Name]

     📜 Microbiology Department 📜

     Certificate of Analyst Qualification

     Certificate Number: ___________
     Date of Issue: ___________

     🎓 [Analyst’s Full Name]

     has successfully demonstrated theoretical knowledge and practical competence and is hereby qualified to perform the following microbiological activities:

     • Total Aerobic Microbial Count (TAMC)
     • Total Yeast and Mould Count (TYMC)
     • Test for Specified Microorganisms:
       • Escherichia coli
       • Salmonella spp.
       • Pseudomonas aeruginosa
       • Staphylococcus aureus
       • Candida albicans
       • Bile-Tolerant Gram-Negative Bacteria
     • Growth Promotion Testing (GPT) of Culture Media
     • Environmental Monitoring:
       • Surface Monitoring (Contact Plates & Swabs)
       • Air Monitoring (Settle Plates & Active Sampling)
       • Personnel Monitoring

     Certificate Validity:
     This qualification remains valid for two (2) years from the date of issue or until significant method/SOP changes occur.

     Authorized Signatories:

     Name	Designation	Signature	Date
     __________________________	Head – Microbiology Lab	__________________________	___________
     __________________________	Quality Assurance Manager	__________________________	___________