Development of new product in RD → transfer of new product from RD to manufacturing site.

Introduction of New Product directly transferred to Existing manufacturing site or New manufacturing site

Introduction of Existing Product directly transferred to New manufacturing site

Support in product development and documentation

Preparation of technology transfer documentation such as

• Technology Transfer / Process Validations / Cleaning Validations
• Any specific environmental / storage / handling requirements
• Training
• Health and Safety / Risk with respect to process and personnel
• Cross contamination and regulatory requirements
• Compliance to GMP requirements
• Stability & control samples are collected and submission
• Vendor Approvals / qualifications
• Analytical specifications and methods, Working / reference standards
• SOPs SOP