Pharmaceutical Manufacturing

The Program is designed to enable the participant to meet Competencies defined in National Occupational Standard for Chemist- Production (Pharma, Cosmetics & Biologics) with specialization in non-sterile product manufacturing in compliance with ICH-cGMP practices, Data Integrity and other applicable legal and regulatory guidelines.

The scope covers the following: 

• Pre-production process monitoring
• Production process monitoring
• Post-production process monitoring
• Adoption of Environment Sustainability Practices
• Reporting, Recording and documentation
• Data Integrity
• Coordination with the Manager/ Supervisor, team members, cross-functional teams
• Audit queries response
• Demonstration of sensitivity towards all genders and people with disability
• Adherence to health and hygiene protocols
• Adherence to safety and security procedures
• Adherence to emergency procedures
• Management of Non-sterile manufacturing process
• Management of GMP compliant documentation

Objectives: At the end of the program, the learner should have acquired the listed knowledge and skills

• Discuss performance of Chemist – Production (Pharma, Cosmetics & Biologics) in compliance with Good Manufacturing Practices (GMP) and other environmental regulatory guidelines.
• Explain the fundamentals of manufacturing process and its various components for non-sterile product manufacturing.
• Demonstrate how to manage production activities across the product line in a life science manufacturing facility.
• Discuss how to maintain a healthy, safe and secure working environment in the production and GMP controlled area.
• Demonstrate how to coordinate with supervisor, colleagues and respond to audit queries during GMP/ regulatory audits.
• Demonstrate sensitivity towards genders, cultures and specially-abled persons.
• Demonstrate the methods of reporting and documentation for regulatory compliance.