PMCC Courses
PMCC – Pharmaceutical Microbiology Competency Certification
All Available Courses – Basic & Expert (SME)
Explore the complete course catalog under the Pharmaceutical Microbiology Competency Certification (PMCC). Courses are segregated into Basic (Access Qualification) and Expert (SME) levels. Each course is designed to be scientifically sound, regulatory aligned, risk-based, and qualification-focused.
LEVEL 1 – BASIC (Access Qualification)
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 – Basics
- Utilities Monitoring – Basic Overview
- Sterilization – Introduction
- Biological Indicators – Basic Concept
- Bacterial Endotoxin Indicators – Awareness
- Sterility Assurance Level (SAL) – Introduction
- HVAC System – Cleanroom Support Overview
LEVEL 2 – EXPERT / SME
1. Advanced Aseptic & Contamination Control
- Advanced Clean Room Qualification
- Aseptic Process Simulation – Media Fill Validation
- Contamination Control Strategy (CCS) – Implementation
- HVAC System – Design & Airflow Visualization
- Sterility Assurance & SAL – Advanced
2. Microbiology Testing Activities
- Staining Procedures (Gram & Special Stains)
- Disinfectant Qualification & Rotation Strategy
- Water Monitoring – Advanced
- Sterility Test (Membrane Filtration & Direct Inoculation)
- Bacterial Endotoxin Test (BET)
- Recombinant Factor C Assay
- Kinetic Method – Endotoxin Testing
- Sub-visible Particulate Testing
- Visible Particulate Testing
- Container Closure Integrity Test (CCIT)
- Preservative Efficacy Test (PET)
- Antimicrobial Effectiveness Test (AET)
- Antibiotic Assay Test
- Bioburden Test – Advanced Approach
- Rapid Microbiology Methods
- Disinfectant Effectiveness Test
- In-house Microbial Flora Identification
3. Quality Management System (QMS) Activities
- Change Control Management
- Deviation Handling
- Incident Management
- Out of Specification (OOS)
- Out of Expectation (OOE)
- Out of Trend (OOT)
- Out of Limit (OOL)
- Risk Assessment (ICH Q9 Based)
- Audit Response Strategy
- Audit Readiness Program
- Root Cause Analysis Techniques
- Investigation Methodology
- CAPA – Corrective & Preventive Actions
- Product Recall Management
Certification Structure
| Level | Eligibility | Assessment Type | Validity |
|---|---|---|---|
| Basic | All Controlled Area Entry Personnel | MCQ + Scenario Based | 1 Year |
| Expert / SME | Microbiologists / QA / Supervisors | Advanced Test + Case Study + Risk Assessment | 2 Years |
All courses are structured based on scientific principles, regulatory alignment (EU GMP Annex 1, WHO GMP, USP guidance), and risk-based pharmaceutical microbiology practices.
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