Good Manufacturing Practices GMP – For Pharmaceutical and Biotechnology

This course provides a comprehensive introduction to Good Manufacturing Practice (GMP), a critical system ensuring that products are consistently produced and controlled according to established quality standards. It is designed for professionals in the Pharmaceutical and Biotechnology industries who are involved in manufacturing, quality assurance, regulatory affairs, and compliance.

Participants will gain a thorough understanding of GMP principles, regulatory expectations (e.g., FDA, EMA, WHO), documentation practices, risk management, validation processes, and the role of GMP in ensuring product safety, quality, and efficacy.

Through real-world examples, interactive modules, and assessments, learners will be equipped to identify GMP violations, implement corrective actions, and contribute to a quality-focused organizational culture, such as Those Found in Pharmaceutical Industries.

Target Audience:

• Graduate and Undergraduate Students in Pharmacy, Life Sciences, Biotechnology, Microbiology, Chemistry, and Engineering.

• Biotech and Pharmaceutical Industry Professionals (Production, Research & Development, Quality Control, Quality Assurance, and Compliance)

Learning Outcomes:

By the end of this course, participants will be proficient in:

• Understand the key principles and purpose of GMP.

• Recognize the regulatory requirements and international guidelines governing

GMP (FDA, EU-GMP, WHO).

• Apply GMP principles in manufacturing environments.

• Identify and respond to GMP non-compliance issues.

• Implement effective documentation and record-keeping practices.

• Support quality systems, including CAPA, change control, and internal audits.

• Contribute to continuous improvement in GMP-regulated settings.

Course Duration:  

2 days, 5 hours/day