PIC/S Compliance: A Comprehensive Guide for Pharmaceutical and Hospital Professionals

Understanding and complying with global pharmaceutical standards is essential for ensuring patient safety and product quality. This course is designed to help healthcare and pharmaceutical professionals navigate the complex requirements of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Through case studies, implementation strategies, and interactive lessons, you’ll learn how to apply PIC/S standards across both industry and hospital settings.

Who should enroll?
This course is ideal for professionals responsible for compliance, quality, and operational standards in healthcare and pharmaceutical settings, including:

• Hospital administrators and clinical pharmacists
• Production and operations managers
• Quality Assurance and Quality Control officers
• Regulatory Affairs specialists
• Pharmacy and laboratory managers

What you’ll learn?
By the end of the course, learners will be able to:

• Understand the origins, framework, and key documents of PIC/S
• Apply core PIC/S GMP principles in manufacturing and hospital settings
• Prepare facilities, staff, and documentation for inspections
• Implement risk-based approaches using QRM tools such as FMEA and Ishikawa diagrams
• Ensure data integrity and manage digital compliance in line with ALCOA+ principles
• Integrate GMP practices into sterile and non-sterile hospital pharmacy operations
• Learn from real-world case studies to improve compliance and operational performance

By completing this course, you will be prepared to implement PIC/S guidelines with confidence, enhance compliance across your organization, and ensure the highest standards of quality and patient safety in both pharmaceutical and hospital settings.

Curriculum:

Module 1: Understanding PIC/S – Origins and Framework

• Historical context and genesis of PIC/S
• Mission, objectives, structure, and membership
• Key documents and harmonization tools
• Benefits of PIC/S participation for authorities and industry
• Case Study: The Thalidomide tragedy and regulatory evolution

Module 2: Core PIC/S Guidelines

• Overview of the PIC/S GMP Guide (PE009)
• Key GMP principles and standards

Module 3: GMP Principles and Inspection Readiness

• Facility and equipment qualification
• Production controls and process validation
• Documentation and record management
• Personnel competence and hygiene
• Quality control, batch release, and deviation handling
• Supplier qualification and material management
• Inspection readiness and continuous improvement

Module 4: Application of PIC/S GMP in Hospital and Healthcare Settings

• Scope of GMP in hospital and healthcare settings
• Sterile and non-sterile compounding, repackaging
• Cleanroom and equipment management
• Documentation, batch records, and integration with hospital quality systems
• Challenges and opportunities in hospital GMP implementation

Module 5: Quality Risk Management

• Principles of ICH Q9 and PIC/S alignment
• FMEA and Ishikawa (Fishbone) diagrams
• Risk-based decision-making in deviations, cleaning, and equipment qualification
• Continuous review and QRM integration

Module 6: Data Integrity and Digital Compliance

• Foundations of data integrity (ALCOA and ALCOA+)
• Electronic record-keeping and audit trails
• Preventing data manipulation
• Managing hybrid data systems and governance
• Inspections and audits for data integrity

Module 7: Case Studies

References

Quiz