Technology transfer from R&D to Production - Industrial Pharmacy II B. Pharma 7th semester PDF Notes
Technology transfer from R&D to Production
Introduction
• Technology transfer creates a bridge between the R&D and Production as it helps in creating more efficient and safe medications
• This is systematic process with proper protocol which should be followed by both the ends while a QA personnel should verify and maintain the documentation included in these protocol.
• Development, transfer, production and documentation are the phases of technology transfer.
Master Formula Card (MFC) – Includes product name along with its strength, generic name, MFC number, page number, effective date, shelf life and market.
Master Packing Card –Gives information about packaging type, material used for packaging, stability profile and shelf life of packaging.
Master Formula Record – Describes formulation order and manufacturing instructions. (Process order and environment conditions)
Specifications and Standard Test Procedures (STP’S) – Helps to know active ingredients and excipients profile, in-process parameters, product release specifications and finished product details
Roles and Responsibilities
| GIVING SITE | RECEIVING SITE |
| • Provide Latest Source documentation. | • Execute Protocol(analytical method) |
| • Latest Specifications (Internal or registered) | • Qualified Facility and equipment or instrument |
| • Provide process(technology) transfer | • Setup system |
| • Protocol/report (analytical report method) | • Setup training program |
Success of Technology transfer
It depends on
Communication –Open communication between all team members
• Direct communication between technical members
• Effective and timely communication with regulators
Sending and Receiving Unit
• Technology transfer is not a “one way street”
• The sending unit and receiving unit must be equally involved in the process to ensure success
• Team work at all time
Checklist of Technology transfer
It consists of,
• Production master formula.
• Manufacturing and Dispensing instructions.
• Analytical methods.
• Cleaning instructions and previous cleaning validation.
• Active specifications and source.
• Primary packaging material specifications and source.
• Packaging instructions.
• Process deviations file, Analytical deviations file.
• Specimen manufacturing batch record
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