Advanced Good Manufacturing Practices

Introduction to Good Manufacturing Practices (cGMP)

Build a Strong GMP Foundation for Daily Operations and Regulatory Confidence

This course presents the principles and fundamental requirements of Good Manufacturing Practices (GMP) and helps participants understand their role within the quality system so they can practice GMP reliably in day-to-day operations. Designed for GMP-regulated industries such as pharmaceuticals and food, the training provides practical knowledge to implement and sustain GMP compliance across production, quality, documentation, warehousing, utilities, and laboratories.

Who Should Attend

Process Engineers / Managers

Validation Managers

Supply Chain / Warehousing Managers

Quality Engineers / Managers

Maintenance Managers

Production Engineers / Managers

Operations Managers

Course Objectives

Upon completion of this course, participants will be able to:

Describe and explain the historical development and current best practices in international cGMPs

Prepare practical and compliant procedures and validation protocols

Audit, validate, and manage critical systems such as HVAC and Water systems

Set up or evaluate environmental monitoring programs for production areas

Conduct compliant cleaning programs

Successfully manage laboratory Out of Specification (OOS) situations

Course Outline

Module 1 — International GMPs and Principles of Quality Management

Regulatory expectations for establishing an effective QMS

Historical development and evolution of GMPs

Differences between regions, codes of practice & guidance

Requirements and obligations of manufacturers and managers

Interpretation of different regulatory agencies

Module 2 — Documentation Systems and Practices: GMP Requirements & Control

GMP documentation structure, format & control

Relationship between manuals, policies, SOPs, work instructions & records

Model hierarchical documentation system (ISO 9001 approach)

Practical batch record example

Strategies for complaint and compliant documentation during audits

Module 3 — HVAC and Controlled Environments: Control & Qualification

Regulatory expectations for cleanroom and controlled manufacturing environments

HVAC validation and environmental monitoring programs

Qualification activities for HVAC systems

Principles of particle filtration and contamination control

Module 4 — Pharmaceutical Water Systems: Design, Control & Validation

Impact of water system performance on product quality

Design, validation & monitoring of pharmaceutical water systems per cGMP

IQ, OQ, PQ requirements and microbiological controls

Module 5 — Cleaning Validation

Regulatory requirements and guidelines for cleaning validation

Establishing residue limits and acceptance criteria

Analytical methods for detection and quantification

Preparation and execution of cleaning validation protocols

Module 6 — Handling Laboratory Out of Specification (OOS) Conditions

Regulatory expectations for managing OOS results

Root-cause investigation and decision-making process

SOPs and documentation for OOS case management

Practical strategies for preventing recurrence

Duration

Three days

Key Takeaways

Deep understanding of core GMP principles and global regulatory expectations

Ability to design, implement, and maintain GMP-compliant systems

Increased confidence in managing audits, documentation, and validation activities

Improved readiness to handle OOS investigations and compliance risks

Strengthened quality culture and operational discipline across departments

Speak to a Training Specialist

Contact

Building #10, Ground Floor, Business Park, Amman, Jordan
+962 (79) 1533337
m.abuzour@agonme.com

Brochures

Investment Evaluation Temp.

Services

Management Representative

Training Programs

Advanced Good Manufacturing Practices