Technology Transfer Sample Protocol in Pharmaceuticals

                             Company Name

                Technology Transfer Protocol

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                                                                               PROTOCOL

TECHNOLOGY TRANSFER

                       Company Name

           Technology Transfer Protocol

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      S. No.

                                       Section

       Page No.

         I.

Technology transfer protocol approval

        II.

Purpose

        III.

Objective

        IV.

Scope

        V.

Key personnel and their responsibilities

        VI.

Technology transfer process

a.       Quality design

b.      Scale-up and detection of quality variability factors

c.       Technology transfer from R&D to production

d.      Validation and Production

                       Company Name

          Technology Transfer Protocol

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I.                   TECHNOLOGY TRANSFER PROTOCOL APPROVAL:

The technology transfer protocol is prepared by integrated inter-disciplinary team of cross functional experts from different departments including Research & Development (R&D), Quality Control (QC), Production Department, Quality Assurance (QA) and Maintenance.

                        Company Name

           Technology Transfer Protocol

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 II.  PURPOSE

To provide documented evidence that (developed by R&D) can be reproduced consistently against a set of predefined specifications.

 III. OBJECTIVE

 To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out information obtained during R&D work.

 IV.  SCOPE

 This protocol applies for complete technology transfer of product within (Company Name).

                        Company Name

             Technology Transfer Protocol

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      Personnel

        Designation

                           Responsibilities

        (R&D)

i. Selection of raw materials

ii. Design and development of manufacturing process for

iii. Identification of critical process parameters

iv. Establishing specifications and analytical test methods

v. Verification of results

    (Production)

i. Provide facility and equipments for performing operation

ii. Performing operation under control

iii. Record results of operation and controls

   Maintenance

i. Calibration and maintenance of equipments

        QC

i. Quality testing of in-process material

ii. Quality testing of finished product

iii. Preparation of certificate of analysis (CoA)

        QA

i. Preparation and review of documentation (protocol and reports) for all processes of technology transfer

      Head QA

i. Approve the documentation (protocol and reports) for all processes of technology transfer

                        Company Name

             Technology Transfer Protocol

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 VI.  TECHNOLOGY TRANSFER PROCESS

Quality is designed based on basic data concerning efficacy and safety obtained from various studies. Various standards for manufacturing and tests will be established in process during reviewing factory production and will be upgraded to the quality of product and the actual production will be started. The technology transfer consists of actions taken in these flows of development to realize the quality as designed during the development stage. The technology transfer processes are classified broadly as mentioned below:

a. Quality Design (Research Phase)

During experimentation work at lab scale, various experiments are designed in order to comply with international quality standards and viability of product in terms of yield of the product. Following lab experiments are conducted:

                     Company Name

           Technology Transfer Protocol

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b. Scale-up and detection of quality variability factors (Development Phase)

                    i. Research for factory production

To manufacture  as per quality standards obtained during lab experiments, it is required to establish appropriate quality control method and manufacturing method, after detecting variability factors to secure stable quality in the scale-up batches that is performed to realize factory production of  designed on the basis of results from small-scale experiments.

Checklist “Laboratory equipments”:

                     Company Name

           Technology Transfer Protocol

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·           Checklist “Raw material specifications”:

                       Company Name

         Technology Transfer Protocol

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ii. Pilot batches

Experimental data

iii. Assurance of consistency through development and manufacturing

The quality parameters should be reproducible in the product. For this purpose, Research and Development (R&D) transfers development data to production for commercial production.

c.       Technology transfer from R&D to Production

R&D transfers technology to production department and it is essential to establish responsibility system and prepare documents to have adequate technology exchange between the both departments for successful transfer. While transferring technology of from R&D department to production department technical information is compiled as development report.

                          Company Name

             Technology Transfer Protocol

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Checklist of “Process equipment” :

                        Company Name

           Technology Transfer Protocol

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d.      Validation and Production (Production Phase)

Based on the above studies of  process at various steps during development of manufacturing process, Master Manufacturing Formula (MMF) is prepared by R&D, which is reviewed and approved by Quality Assurance (QA) Department. From MMF, Batch Manufacturing Record (BMR) is derived and production is started in the plant at commercial scale based on the successful pilot scale batches which are proven to be validated batches. While starting production of  in the plant, the data obtained from R&D department in the form of MMF is followed.

    Batch No.

   Manufacturing               date

Batch size

   Yield

  Usage of product

  Purity

  For Benchmarking

      S. No.

         Name of Sample

                      Content (%)

          1.

In-house sample

         2.

Market sample-1

         3.

Market sample-2

    S. No.

     Critical steps

         Parameters

            Control range

  S. No.

                  Test

                               Specification