May 2, 20231

Evaluation of Technology Transfer Approaches of Solid Dosage Form, From R & D to Manufacturing Site.

Name of StudentMr. Rakesh M. Wani (M.Pharm IV sem)

(Department of Quality Assurance technique)

Name of GuideMr. Arun M. Kashid

(M. Pharm) (Department of Pharmaceutical

Chemistry)

STES’s,

Sinhgad Institute of Pharmacy, Narhe, Pune - 411041

May 2, 20232

1. Introduction

2. Literature survey

3. Aim and Objective

4. Plan of work

5. Material and Method

6. Evaluation parameter

7. Source of data

8. Outcome

9. References

CONTENT

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“The transfer of the manufacturing process for a new pharmaceutical Drug

Substance (DS) and Drug Product (DP), respectively, from the transferring site

(in this case R&D) to the receiving site or designated commercial manufacturing

site.” This includes all the associated knowledge, information and skills to be

able to manufacturing the DS and DP at the receiving site.

Introduction

Definition

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Development of technology by

R&D

Technology transfer from

R&D to production

Optimization and Production

Technology transfer

documentationExhibit

Steps in technology transfer

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Development of technology by R&D

Design of procedure and selective of excipients by

R&D

Identification of specification and quality by R&D

1. Step

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Technology transfer from

R&D to production

Master formula

card

Master packaging

card

Master formula

Specifications and standard test procedure

2. Step

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Optimization &

Production

Validation studies

Scale up for production

3. Step

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Developmen

t report

Technology transfer plan

Packaging development Report

4. Steps in technology transfer4. Step

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Lack of manufacturing capacity Lack of resources to launch product

commercially Lack of marketing and distribution capability No commercial capability

Reasons for technology transfer

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The more effectively knowledge is shared within an organization.

Innovative R&D.

Drug Approvals.

Effective commercialization.

Ensure safe, pure and effective drug product.

Cost effective production and distribution.

Advantages

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Literature Review

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LITERATURE REVIEW

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LITERATURE REVIEW

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LITERATURE REVIEW

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LITERATURE REVIEW

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LITERATURE REVIEW

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LITERATURE REVIEW

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AIM: Evaluation of technology transfer approaches of solid dosage form, from R & D to manufacturing site.

OBJECTIVES: To enhance manufacturing capacity. For good business and manufacturing practices. To transfer the knowledge throughout the organization. To identify the knowledge gaps that need to fill up.

AIM AND OBJECTIVE

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Plan of Work

Literature Survey

Drug excipient profile

A) Scale up batch

Experimental work

B) Exhibit batch

C) Evaluation Parameters

Data Compilation

Result and discussion

2 Month

1 Month

2 Month

1 Month

1 Month

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Drug Substance (API) and other excipients with their manufacturer.Material

Material and Method

MethodAPI and other excipients for various operation like,

Dispensing, Sifting, Mixing, Granulation, Drying, Blending, Compression, Coating, etc.

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EVALUATION PARAMETERS

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Particle size and size distribution

Infrared spectroscopy

X-ray powder diffraction studies

Physiochemical study

DSC

Thin layer chromatography

Characterization of Drug sample

OrganolepticEvaluation

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Tapped density

Carr's index

Hausner ratio

Bulk density

Loss on drying

Sieve analysis

Characterization of Powder blend

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Thickness

Hardness

Friability

Dissolution study

Disintegration study

Assay

Characterization of Finished product

Average weight

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SOURCES OF DATA

R & D documents or Transferring site documents.Lab Note Book ( LNB)Trade JournalInternet Sourcing

Sources of data

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Technology transfer is important to upgrade the quality of design to be the

quality of product, and ensure stable and high quality of product.

The ultimate goal is to effectively transfer product and specification,

manufacturing and control operations.

EXPECTED OUTCOME

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1. WHO guideline on transfer of technology in pharmaceutical manufacturing.

2. Gupta P, Agrawal A, Sara U, (2013),Technology transfer in Pharmaceutical

Industry, International journal of universal pharmacy and bio sciences.

2(2)93-101.

3. Gupta S, Saini S, Rana A.C., Chugh Isha, (2012), Technology transfer in

Pharmaceutical Industry, International Pharmaceutical Sciencia. 2(3)1-6.

References

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Kyrikos Drivas, Claire Economidou, Dimitris Karamanis, Arleen Zank,

(2016), Academic patents and technology transfer, Journal of engineering and

technology management.1-19.

Kaur A, Sharma o, (2013), Technology Transfer in Pharmaceutical Industry.

International Journal of Current Pharmaceutical Research. 5(12)1-5.

Manral M.S, Prashar B, Sheikh Y, (2012), Technology transfer in

pharmaceutical industry; Facts and steps involved. American journal of

pharmaceutical research. 2(4)73-83.

4.

5.

6.

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Manu C, N Vishal Gupta(2016), Review on technology transfer in

pharmaceutical industry, International journal of pharmaceutical quality

assurance. 7(1)7-14

Ali s, Pandit v, Shekhar c, (2012), Technology transfer in Pharmaceutics.

International Research Journal of pharmacy. 3(6)43-48.

Chanad Sharma, (2016), R&D Technology transfer & Productivity in the Indian

pharmaceutical industry, International Journal Of Innovation Management.

20(5)1-24.

7.

8.

9.

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