Course Overview:

If you work in pharmaceutical manufacturing or GMP compliance, it is essential to understand your regulatory responsibilities, the structure of a Pharmaceutical Quality System, and the core expectations of Good Manufacturing Practice (GMP) under PIC/S. This course provides a practical, streamlined introduction to the key requirements in the PIC/S Guide to GMP Part I, supported by real-world examples to show how GMP principles protect product quality and prevent issues like adulteration and misbranding.

Course Outline:

Day 1 — Global GMP Fundamentals

Regulatory Overview

• Product lifecycle: development → manufacturing → testing → distribution
• Key regulators and harmonized standards (PIC/S, FDA, NPRA, EMA, WHO)
• Quality System types and major GMP frameworks (PIC/S PE009, 21 CFR 210/211, EU GMP)
• Purpose of GMP: ensuring identity, safety, quality, strength, and efficacy
• Main inspection focus areas and compliance priorities

GMP Essentials

• Personnel roles, training, and qualification
• Facility design, cleanliness, and controlled flows
• Production and processing areas: contamination and mix-up prevention
• Storage and warehouse controls, including temperature management
• QC labs and analytical responsibilities
• Utilities and support systems (HVAC, water, gases)
• Equipment qualification, calibration, and maintenance
• Process and packaging controls across manufacturing
• Validation of systems, methods, and equipment
• QC duties: sampling, testing, batch documentation, and release

Day 2 — Documentation Excellence & Quality Systems

Good Documentation Practices (GDocP)

• GMP requirements for documentation and controlled records
• Purpose of GDocP and its link to data integrity (ALCOA+)
• Frequent documentation errors and how to avoid them
• Writing clear SOPs, work instructions, batch records, and forms
• Structuring documents for use, clarity, and audit readiness

Quality Systems Approach

• Pharmaceutical Quality System (ICH Q10) overview
• Quality Risk Management (ICH Q9) principles
• Core QMS processes for ongoing control:
– Deviations & non-conformances
– Complaints & recalls
– CAPA processes
– Change control
– Product Quality Review (PQR/APQR)
• How QMS components maintain a state of control and support continuous improvement

Participants

This course provides newcomers to the pharmaceutical industry with a strong foundation in PIC/S GMP principles and Pharmaceutical Quality System expectations. It is equally beneficial for experienced GMP professionals looking to stay current with PIC/S requirements, organizations preparing for new or renewed GMP certification, and manufacturers engaged in secondary packaging of medicinal products.