Technology Transfer Sample Protocol in Pharmaceuticals

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In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full-scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology.
Learn about how to write “Technology Transfer” Protocol.
                             Company Name
 
                Technology Transfer Protocol
Document Code
Issue Date
Page No.
                                                               
                                                                               PROTOCOL
 
TECHNOLOGY TRANSFER
 
 
 Format No:_____                                                                                                                     Page No.______
                       Company Name
 
           Technology Transfer Protocol
Document Code
Issue Date
Page No.
 
                                                                     TABLE OF CONTENTS
      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
 Format No:_____                                                                                                                  Page No.______
                       Company Name
 
          Technology Transfer Protocol
Document Code
Issue Date
Page No.
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.
       Name
                    Designation
       Signature & Date
 
 
 
 
 
 
 
 Format No:_____                                                                                                                  Page No.______
                        Company Name
 
           Technology Transfer Protocol
Document Code
Issue Date
Page No.
 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).
 
 
  Format No:_____                                                                                                                  Page No.______
                        Company Name
 
             Technology Transfer Protocol
Document Code
Issue Date
Page No.
V.  KEY PERSONNEL AND THEIR RESPONSIBILITIES
      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
 Format No:_____                                                                                                                  Page No.______
                        Company Name
 
             Technology Transfer Protocol
Document Code
Issue Date
Page No.

 

 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:
 Format No:_____                                                                                                                  Page No.______
                     Company Name
 
           Technology Transfer Protocol
Document Code
Issue Date
Page No.
 
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”:
     S. No.
                                        Name of Equipment
       1
       2
       3
      4
      5
      6
      7
      8
      9
 Format No:_____                                                                                                                  Page No.______
                     Company Name
 
           Technology Transfer Protocol
Document Code
Issue Date
Page No.
·           Checklist “Raw material specifications”:
     S. No.
        Name Of Raw Material
               Specification No.
       1
      2
      3
      4
     5
     6
     7
     8
    9
   10
   11
   12
   13
   14
 Format No:_____                                                                                                                  Page No.______
                       Company Name
 
         Technology Transfer Protocol
Document Code
Issue Date
Page No.
 
ii. Pilot batches
Experimental data
        Batch No.
Manufacturing               date
Batch size
   Yield
 Usage of        product
    Purity
   1.0 kg
 For Stability
    Studies
   1.0 kg
   1.0 kg
 
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.
 Format No:_____                                                                                                                  Page No.______
                          Company Name
 
             Technology Transfer Protocol
Document Code
Issue Date
Page No.
Checklist of “Process equipment” :
         S. No.
                                    Name of Equipment
 Format No:_____                                                                                                                  Page No.______
                        Company Name
 
           Technology Transfer Protocol
Document Code
 Issue Date
 Page No.
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.
Format No:_____                                                                                                                  Page No.______
 5.0 TRIAL PRODUCTION BATCHES
  • Experimental data
 
    Batch No.
   Manufacturing               date
Batch size
   Yield
  Usage of product
  Purity
  For Benchmarking
 
6.0 BENCHMARKING
Benchmarking is the process of measuring quality standards of  against the best market product available. Benchmarking provides necessary insights to help us understand how our drug substance compares with market samples. In this process drug product has been compared with market samples; data shows that our material is comparable to market samples and HPLC chromatograms are also studied in terms of impurity profile.
Summary table of benchmarking:
      S. No.
         Name of Sample
                      Content (%)
          1.
In-house sample
         2.
Market sample-1
         3.
Market sample-2
 
 
Affix
Chromatogram of  (Blank)
 
 
 
Affix
Chromatogram of  (Standard)
 
 
Affix
Chromatogram of  (In-house Sample)
Affix
Chromatogram of  (Market Sample-01)
Affix
Chromatogram of  (Market Sample-02)
 

 

 7.0 CRITICAL STEPS AND CONTROL RANGE OF PROCESS PARAMETERS
 
    S. No.
     Critical steps
         Parameters
            Control range
 8.0 PRODUCT SPECIFICATIONS:
  S. No.
                  Test
                               Specification
 9.0 PROCESS FLOW CHART

 

 

Prepared & Submitted by:
jyotiphoto
Ms. Jyoti Kushwaha
QA/RA

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