TECHNOLOGY TRANSFER
Inventland team know the importance of Technology Transfer.
We have a responsible department for successful Transfer of Technology of Product from its Development site to it’s Manufacturing site.
Our main objective is providing clear and understandable procedure of Technology Transfer process in Pharmaceutical Industry.
We ensure that transfer of scientific knowledge, Technology and Manufacturing Process from the Development site to Commercialization.
Our team identify the Critical Quality attributes in the process, terchnology and mentioned or highlighted in respective documents i.e. Batch Processing Record, Protocols Manufacturing Formula Record, Analytical Method Development/Validation, Stability Study, Testing Procedure incorporation, In process and Finished Product Specification, So that quality cannot we alter and it produces consistently.
The team of Inventland thoroughly evaluate technology and protection so it cannot affect the Quality, Safety and Efficacy of Product.
We focused on the following points during Technology Transfer.
RAW MATERIAL:
Our team provides the related information of Active Material.
- Solubility of Active Pharmaceutical Ingredient at different pH
- Stability of API in Solution
- Stability of API in Solid
- Particle Size Distribution
- Dissolution Profile
- Manufacturing process of Active Pharmaceutical Ingredient
- Physical Property
- Moisture Content
- Water Activity
- Loss on Drying
- Bio Burden
- Supply chain of Active Pharmaceutical Ingredient
- Sensitivity to Heat, Light, Moisture
EXCIPIENTS
- Manufacturing of Pharmaceutical Ingredient
- Physical Properties
- Bulk Density
- Tapped Density
- Solubility and Stability in Solution
- Moisture Content & Loss on Drying
- Effect of Particle Size on Dissolution Profile
- Melting Point
- Bio Burden
- Material Safety Data Sheet
- Supply chain of Active Pharmaceutical Ingredient
- Sensitivity to Heat, Light, Moisture
MANUFACTURING FACILITY
Our team provide the complete information regarding facility design it includes:
- Equipment to be used for Product.
- Quality Control Tool.
- Analytical Method Transfer.
- Raw, Packaging Material & Finished Product Specification.
- Cleaning Validation
IN- PROCESS MATERIAL
Our team provide the complete information on Manufacturing Process Control, Physical Evaluation Parameter, In Process Specification and Critical Quality Attributes
FINISHED PRODUCT
Product Development team provided complete information of Finished Product Specification and background of Product Development for successful Transfer of Technology and provide a full support from Commercialization to whole Shelf Life of Product.
PACKAGING PROCESS
Complete information on Container Closure, Designing of Artwork.
CLEANING PROCESS
Product Development team validate complete detail of Cleaning Procedure includes Therapeutic Dose, Solubility of Raw Material, Toxicity and use of Cleaning Agent and Method of Recovery for Cleaning Residue.
DOCUMENTATION
It includes Product Development Protocol, Product Development Report, Batch Processing Record,Technology Transfer Protocol, Process Validation Protocol, Process Validation Report, Cleaning Validation Protocol and Report & Stability Study Protocol & Report.