a.

A transparency between both parties shall be maintain during technology transfer because any lack of
transparency may lead to ineffective transfer of technology.

b. For the successful technology transfer following general principal and requirement should be met;

 Project plan shall be encompass the quality aspects of the project and plan should be based on the
quality risk management principles to identify all the hazards and their mitigation plan.

 Technology transfer shall be handled through change control procedure.

 A comprehensive technical & regulatory gap assessment between sending site and receiving site
shall be done before technology transfer.

 During technical and regulatory gap assessment following points shall be considered but not limited
to:

 Equipment equivalence of sending site and receiving site w.r.t. capacity, working principle shall be
consider during risk assessment, if both site equipment are different in terms of capacity and
working principle then adequate risk mitigation plan shall be proposed like process optimization,
critical control parameter identification & process validation with receiving site equipment, batch
size determination based on the equipment capacity etc.

 Manufacturing formula, method of manufacture, bulk specification and finished goods

specification should be freeze and approved before transfer of technology.

 Area classification of both sending site and receiving site shall be verified for its equivalence.
Classification of both site where product manufactured should be same and qualified against a
predefined standard and raw material and product requirement like relative humidity, temperature,
non-viable and viable counts, differential pressure etc.

 Water quality (raw water, purified water, water for injection, pure steam) of sending site and
receiving site shall be assess for its equivalence. Water is the main source of microbial
proliferation so microbial limit should not be more than finished goods specification of product
and water system should be qualified against pre-defined specification before its use.

 Availability of all other critical utilities shall be ensure before technology transfer. All the critical
utilities and its capacity like pressure, purity, piping and design should match with the sending site
critical utilities used in the manufacturing/ packaging of respective product.

g. Apart from all technical details personnel knowledge transfer is also required to make technology transfer
successful so all the SME (Subject Matter Expert) of sending site is responsible to provide the technical /
operational / analytical training to the receiving site respective area personnel.

h. In case of new product development and transfer to the manufacturing site from R&D analytical method to be
developed by R&D and suitability of that method shall be verified at manufacturing site quality control
laboratory. In case of technology transfer from one manufacturing site to another manufacturing site responsible
person of sending site quality control shall be transferred method at receiving site and trained to all the personnel.
Analytical method transfer activity shall be done through approved protocol and method transfer report shall be
approved by both parties (sending site and receiving site) then only analytical method transfer will be treated as
confirm

i. If method is available in pharmacopeia then pharmacopeia method shall be followed.

j. Technology transfer shall be performed through an approved protocol which consist following but not limited to;

Objective: A clear objective in the protocol is required which state that this protocol is applicable for the
technology transfer of “Product, Dose” from “sending site with complete address” to “receiving site with
complete address- facility”

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 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:

4 B). Technology Transfer Procedure:-

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:

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

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 Checklist “Raw Materials Specification”

S. No. Raw Material Specifications Specification No

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ii.  Pilot Batches
Experimental data
Usage of  
S. No. Batch No. Manufacturing Date Batch Size Yield Purity
Product

    1.0 kg

    1.0 kg For Stability

Studies

    1.0 kg

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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.

Checklist “Processing equipments”

S. No. Name of Equipment

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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.

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iii.  Trial Production batches
Experimental data

S. No. Batch No. Manufacturing Date Batch Size Yield Usage of         product Purity

    1.0 kg

    1.0 kg For Bench Marking

    1.0 kg

5.0 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 Chromatogram/UV Spectrums are also studied in terms of impurity profile.

Summary table of benchmarking:

S. No. Sample ID Batch No. Manufacturing Date Expiry Date Content (%)

In-house sample

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 Market sample-1

Market sample-2

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Affix
Chromatogram/UV Spectrum of  (Blank)
  
Affix
Chromatogram/UV Spectrum of  (Standard)
 
 
Affix
Chromatogram/UV Spectrum of  (In-house Sample)

Affix
Chromatogram/UV Spectrum of  (Market Sample-01)

Affix
Chromatogram/UV Spectrum of  (Market Sample-02)

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6.0  CRITICAL STEPS AND CONTROL RANGE OF PROCESS PARAMETERS
 

S. No. Critical steps Parameters Control range

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7.0  PRODUCT SPECIFICATIONS:

S. No. Test Specification

8.0  PROCESS FLOW CHART

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9.0  CHECKLIST OF DOCUMENTS PROVIDE DURING TECHNOLOGY TRANSFER

S. No. Document Details Doc. No.

Raw Material Data (API)

01
(API DMF, API CoA, API Specs, Excipients Specs)

02 Inprocess Product Specs

03 Finished Product Specs

04 Master Formulation

05 Manufacturing Details

Validation Data (Cleaning, Method & Process Validation

06
Reports)

07 Stability Reports

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 08 List of QC Equipment Used in Testing

09 List of Production Equipment Used in Manufacturing

10 Comparative Dissolution Studies Data

11 Scale Up Studies

12 Change Control Procedure

13 Technical and Regulatory Gap Assessment Report

14 Manufacturing Area Classification Report

15 Water Quality Report - CoA

16 Training Record

17 Packaging Material Report - CoA

18 List of Required Chemicals

19 Technology Transfer Summary Report

20 Others.____________________________________

10. References:-
5.1 Scale-up & Technology Transfer as a Part of Pharmaceutical Quality Systems
https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/ucm
291604.pdf

5.2 Guidelines for technology Transfer

http://www.nihs.go.jp/drug/GMP/04BDH0149-2post.pdf

5.3 Basic Principles of GMP Transfer Of Technology

www.who.int/medicines/areas/quality_safety/quality_assurance/TOT_Part1.pdf

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11. Record:-

Document No. Description Retention Time

Analytical Balance Log Book
UV Spectrophotometer Log Book
HPLC Log Book
Analytical Balance Log Book
In-Process Register
Method Validation Procedure
System Suitability Procedure
Training Record
Cleaning Log Books

12. Distribution:-

Copy No. Destination Issued Date Issued To

01 Electronic Copy QMD
02 Master copy QMD
03 Quality Assurance Department
04 Quality Control Department
05 R&D Department

13. History:-

Revision No. Description

00 New Document

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