Phase II: What can be done over the next 6 months
Setting up Mini Development Centres in select Pharma colleges spread across the Country where Skill development centres are already established. These Mini Development Centres can be set up with the help of Pharmaceutical Manufacturers.

In this Phase, the emphasis will be on - Updating Theoretical inputs on the procedures, practices & documentation that are being followed in Pharmaceutical / Bio-tech industries with National & International Regulatory Compliance and Providing some amount of hands on experience in Formulations Development, Scale up and Manufacturing

QUALITY CONTROL & STABILITY TESTING:

• Raw Material Testing & Analysis
• Packaging Material Testing & Analysis
• In-Process Testing & Analysis
• Finished Good Testing & Analysis
• Accelerated Stability
• Intermediate Stability
• Real Time Stability
• Climatic zones

DRUG REGULATORY SUBMISSIONS:

• Investigational New Drug Applications
• New Drug Applications
• Abbreviated New Drug Applications
• Drug Master Files
• Dossiers

GxP PRACTICES:

• Good Manufacturing Practices
• Good Laboratory Practices
• Good Clinical Practices
• Good Storage Practices
• Good Distribution Practices

PROCEDURES:

• Manufacturing
• Quality control
• Change control
• Cleaning
• All kind of SOPs and SOIs to be followed in Manufacturing industries