PMCC Examination Policy

PMCC – Pharmaceutical Microbiology Competency Certification

Examination Policy & Certification Guidelines

This document defines the official examination policy governing the Pharmaceutical Microbiology Competency Certification (PMCC). The policy ensures fairness, scientific integrity, regulatory alignment, and competency-based qualification.

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1. Purpose of Examination

The PMCC examination is designed to evaluate knowledge, practical awareness, risk-based thinking, and regulatory understanding in pharmaceutical microbiology. Certification is granted only upon demonstrated competency, not attendance.

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2. Examination Levels

Level 1 – Basic (Access Qualification)

• Mandatory for personnel entering manufacturing and microbiology controlled areas
• Focus: Fundamental microbiology, contamination control, GMP behavior
• Assessment: MCQ + Scenario-based evaluation

Level 2 – Expert / SME

• Designed for Microbiologists, QA professionals, Supervisors
• Focus: Investigation, risk assessment, regulatory compliance
• Assessment: Advanced written test + Case study + Risk analysis

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3. Eligibility Criteria

Level	Minimum Eligibility
Basic	Completion of PMCC Basic training modules
Expert / SME	Minimum 1 year relevant pharmaceutical microbiology experience + Basic certification

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4. Examination Structure

Basic Level

• 50 – 100 MCQs (Randomized)
• 10 Scenario-based questions
• Duration: 60–90 Minutes

Expert Level

• 100 MCQs (Advanced)
• 2–3 Case Study Investigations
• Risk Assessment Exercise
• Optional Viva / Oral Defense
• Duration: 120–180 Minutes

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5. Passing Criteria

Level	Minimum Passing Score	Additional Requirement
Basic	Minimum 70% Overall	Minimum 70% in each section
Expert / SME	Minimum 70% Overall	Case Study must be independently cleared

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6. Re-Examination Policy

• Candidate failing the examination must undergo retraining before reattempt
• Maximum 3 attempts permitted within 6 months
• Failure after 3 attempts requires full module repetition

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7. Certification Validity

Level	Validity Period	Requalification
Basic	1 Year	Annual Requalification Mandatory
Expert / SME	2 Years	Re-certification Exam Required

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8. Examination Integrity & Confidentiality

• All examination questions are confidential property of PMCC
• Copying, sharing, recording, or reproducing exam content is prohibited
• Random question engine ensures fairness
• No-repeat question algorithm may be implemented

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9. Misconduct Policy

The following actions constitute examination misconduct:

• Cheating or attempting to access unauthorized materials
• Impersonation
• Collaboration during examination
• Recording exam content

Misconduct may result in:

• Immediate disqualification
• Suspension from PMCC certification
• Permanent ban (severe violations)

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10. Appeals Process

• Appeals must be submitted within 7 working days of result declaration
• Formal written justification required
• Independent review panel decision shall be final

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11. Digital Certification & Verification

• Each certified candidate receives a unique Certification ID
• Digital verification portal may be available
• Certification status can be validated online

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12. Policy Review & Updates

This examination policy is subject to periodic review based on:

• Regulatory updates (EU GMP Annex 1, WHO GMP,PICs, USP & US FDA)
• Industry best practices
• Internal quality improvements

Updated versions shall be published with revision control.

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Declaration

PMCC certification confirms demonstrated competency in pharmaceutical microbiology based on scientific principles, regulatory alignment, and risk-based evaluation. Certification does not replace employer responsibility or regulatory authority requirements.