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British University of Technical Studies > Courses > Health > Global Certificate in WHO–PIC/S Pharmaceutical Manufacturing & Quality Systems (GCPMQ)

Global Certificate in WHO–PIC/S Pharmaceutical Manufacturing & Quality Systems (GCPMQ)

Categories: Health
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About Course

INTRODUCTION

Current Good Manufacturing Practices (cGMP) form the foundation of regulatory compliance for every pharmaceutical, nutraceutical, and biotech manufacturing facility worldwide. Adherence to cGMP aligned with WHO guidelines, PIC/S standards, and international regulatory expectations is essential not only for certification but also for ensuring patient safety, product quality, and organizational excellence.

This comprehensive Certificate program has been developed using the WHO/Pic/s Body of Knowledge (BoK) and global compliance frameworks. It provides a complete, end-to-end understanding of the pharmaceutical manufacturing supply chain, integrating technical operations, quality systems, regulatory affairs, business performance, and modern digital transformation (Pharma 4.0).

The program is ideal for professionals seeking to strengthen their compliance knowledge, enhance practical problem-solving skills, and position themselves for career growth in any department within the pharmaceutical industry.

 

 

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What Will You Learn?

  • OBJECTIVES
  • 1. To provide an interactive, real-world simulation of shop-floor operations, deviations, and compliance challenges, enabling participants to propose solutions aligned with international cGMP, WHO, and PIC/S guidelines.
  • 2. To develop real-time decision-making and problem-solving capabilities essential for regulatory inspections and daily operations.
  • 3. To enhance participants’ understanding of advanced pharmaceutical concepts, modern technologies, and global best practices across manufacturing, quality, regulatory, supply chain, validation, and business functions.
  • 4. To groom participants for regulatory audits, including WHO, DRAP, USFDA, EMA, PIC/S, and MHRA expectations.

Course Content

1. Pharmaceutical Facility & System Design
• Facility structure, zoning, HVAC, and cleanroom classifications • Water systems, utilities, equipment lifecycle management • WHO & PIC/S facility compliance expectations

  • • Facility structure, zoning, HVAC, and cleanroom classifications
  • • Water systems, utilities, equipment lifecycle management
  • • WHO & PIC/S facility compliance expectations

2. Pharmaceutical Product Quality
• Critical quality attributes (CQAs) • Product lifecycle and QbD principles • Quality Risk Management (ICH Q9)

3. Quality Management System (QMS)
• ICH Q10 alignment • Documentation systems, SOP writing, and record control • Data integrity (ALCOA+, GAMP 5 principles)

4. Performance & Operational Excellence
• KPI-based performance management • Lean tools (5S, Kaizen, VSM) • Six Sigma concepts for pharmaceutical operations

5. Quality as a Core Business Strategy
• Linking quality with business competitiveness • Cost of poor quality (COPQ)

6. Regulatory Affairs & Governance
• Global regulatory frameworks (WHO, PIC/S, ICH, FDA, EMA) • Dossier submission & eCTD • Product registration pathways

7. Digital Transformation & Pharma 4.0
• Smart manufacturing (IoT, AI, automation) • Serialization & track-and-trace • Digital batch records & MES/LIMS systems

8. Risk Management across the Supply Chain
• FMEA, HACCP, supply chain security • Vendor qualification & audits

9. Project Management for Pharma Improvement
• Project planning, execution, and validation • Change management & continuous improvement

10. Laboratory Systems & Compliance
• Analytical method validation • Compendia testing & OOS/OOT investigations • ISO 17025 compliance and lab optimization

11. Production Operations
• Equipment design & qualification • Environmental controls • Material flow, warehousing, distribution & GDP

12. Post-Market Surveillance
• Complaints handling, pharmacovigilance • Recalls, incident reporting, and CAPA management

13. Validation & Qualification
• Process validation (Stage 1–3 per FDA/ICH) • Cleaning validation & self-inspection • Computer system validation (CSV)

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