PMCC Structure

PMCC – Pharmaceutical Microbiology Competency Certification

Course Structure – Basic & Expert (SME) Modules

The PMCC (Pharmaceutical Microbiology Competency Certification) is a risk-based, regulatory-aligned, scientifically designed competency evaluation program. This certification is structured into two progressive qualification levels:

  • Level 1 – Basic (Access Qualification)
  • Level 2 – Expert / SME (Subject Matter Expert Certification)

LEVEL 1 – BASIC MODULE

Mandatory for all personnel entering manufacturing, sterile, microbiology, and controlled areas. Focus: Fundamental understanding, contamination awareness, GMP behavior, and operational discipline.

1. General Foundation Courses

  • Basic Microbiology Concepts
  • Personnel Hygiene & GMP Behavior
  • Data Integrity (ALCOA Principles)
  • Hand Sanitization & Disinfectant Procedures

2. Aseptic Area Concepts

  • Clean Room Classification (Grade A, B, C, D)
  • Clean Room Behavior & Operations
  • Aseptic Process Simulation / Media Fill Awareness
  • Contamination Control Strategy (CCS) – Basic Overview

3. Microbiology General Activities (Awareness Level)

  • Media Management
  • pH Meter Handling
  • Balances – Weighing Discipline
  • Culture Management
  • Environmental Monitoring
  • Utilities Monitoring (Water, Compressed Air)
  • Sterilization Basics
  • Biological Indicators – Introduction
  • Bacterial Endotoxin Indicators – Awareness
  • Sterility Assurance Level (SAL) – Basic Concept
  • HVAC System – Cleanroom Support System

LEVEL 2 – EXPERT / SME MODULE

Designed for Microbiologists, QA professionals, Sterility Testing Analysts, Environmental Monitoring Experts, and Supervisory Roles. Focus: Decision-making, investigation, risk assessment, regulatory compliance.

1. Advanced Aseptic & Contamination Control

  • Advanced Clean Room Qualification
  • Aseptic Process Simulation – Media Fill Validation
  • Contamination Control Strategy (CCS) – Implementation
  • HVAC Design & Airflow Visualization
  • Sterility Assurance & SAL Deep Understanding

2. Microbiology Testing Activities

  • Staining Procedures (Gram & Special Stains)
  • Disinfectant Qualification & Rotation
  • Water Monitoring – Advanced
  • Sterility Test (Membrane Filtration & Direct Inoculation)
  • Bacterial Endotoxin Test (BET)
  • Recombinant Factor C Assay
  • Kinetic Method (Endotoxin Testing)
  • Sub-visible Particulate Test
  • Visible Particulate Test
  • Container Closure Integrity Test (CCIT)
  • Preservative Efficacy Test (PET)
  • Antimicrobial Effectiveness Test (AET)
  • Antibiotic Assay Test
  • Bioburden Test
  • Rapid Microbiology Methods
  • Disinfectant Effectiveness Test
  • In-house Microbial Flora Identification

3. Quality Management System (QMS) Activities

  • Change Control
  • Deviation Management
  • Incident Handling
  • Out of Specification (OOS)
  • Out of Expectation (OOE)
  • Out of Trend (OOT)
  • Out of Limit (OOL)
  • Risk Assessment (ICH Q9 Based)
  • Audit Response
  • Audit Readiness Program
  • Root Cause Analysis
  • Investigation Techniques
  • CAPA (Corrective & Preventive Actions)
  • Product Recall Management

Course Segregation Strategy

Level Target Audience Focus Area Pass Criteria
Basic Operators,Microbiologist,IPQA,IPQC, QC, QA, Entry Personnel, Support Staff Awareness, Behavior, Fundamentals Minimum 70%
Expert / SME Microbiologists,Operators, Engineering,QC, QA, IPQA, IPQC, Mangers, Supervisors Investigation, Risk, Decision Making Minimum 70% + Case Study Clearance

Program Philosophy

  • Scientifically Sound & Regulatory Aligned
  • Risk-Based Thinking Approach
  • Practical & Scenario-Driven Assessment
  • Qualification-Focused (Not Just Training)
  • Annual Requalification & Digital Verification

PMCC is designed to create globally competent pharmaceutical microbiology professionals with strong scientific knowledge, contamination control awareness, and regulatory confidence.

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