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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