Packaging Development Lead

Packaging Development of India and US projects

• Literature Search, Regulatory guidelines information for Packaging
• Packaging development strategy.
• CCS Risk assessment, QTPP and CQAs.
• CCS BOM for COGS and Budget
• Product definition II (Trade Dress II)
• Selection/development of suitable CCS for the projects and Identification of Source
• Preparation of Innovator pack characterization report.
• CCS evaluation Protocols with drug product e.g. leak test, compatibility, dose study etc.
• CCS evaluation e.g. drawing, dimension, fitment study, leak test, washing study etc.
• Bracketing and Materixing approach if require
• Packaging component specification and standard test procedure.
• New packaging ideas and packaging design development
• Monitoring lab batch packaging for R&D stability study.
• Packaging development report

Device Study and its Development Activities

• Evaluation of reference device design and Patent
• Selection of suitable device for the projects and identification of sources for device.
• Threshold analysis of devices.
• Device design verification and validation
• IFU and Risk Assessment and risk mitigation plan (URRA)
• Scope of Human Factor Study

Industrialization Design Tech Transfer (Exhibit Batch)

• Operational packaging feasibility study & machine trial at CMO.
• Technology transfer documents
• Packaging component specification
• Standard test procedure
• Facilitate the execution of plant level packaging activity during tech transfer

Industrialization - Commercial Launch

• CMO equipment train for commercial packaging line automation
• Operational feasibility & machine trial with actual commercial packaging components at CMO
• Art work development for packaging
• Finalization of secondary & territory packaging components, including serialization and palletization
• Technology transfer documents for commercial
• Packaging component specification
• Standard test procedure
• Post market changes if any.

Submission Support for ANDA/NDA Projects

• Technical documents with vendor
• Artwork development for submission
• FDA query related to packaging
• Pre-IND support
• Threshold Analysis
• Controlled Correspondence related to Device and Packaging components