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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
May 2, 20233
“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
May 2, 20234
May 2, 20235
Development of technology by
R&D
Technology transfer from
R&D to production
Optimization and Production
Technology transfer
documentationExhibit
Steps in technology transfer
May 2, 20236
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
May 2, 20237
Technology transfer from
R&D to production
Master formula
card
Master packaging
card
Master formula
Specifications and standard test procedure
2. Step
May 2, 20238
Optimization &
Production
Validation studies
Scale up for production
3. Step
May 2, 20239
Developmen
t report
Technology transfer plan
Packaging development Report
4. Steps in technology transfer4. Step
May 2, 202310
Lack of manufacturing capacity Lack of resources to launch product
commercially Lack of marketing and distribution capability No commercial capability
Reasons for technology transfer
May 2, 202311
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
May 2, 202312
Literature Review
May 2, 202313
LITERATURE REVIEW
May 2, 202314
LITERATURE REVIEW
May 2, 202315
LITERATURE REVIEW
May 2, 202316
LITERATURE REVIEW
May 2, 202317
LITERATURE REVIEW
May 2, 202318
LITERATURE REVIEW
May 2, 202319
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
May 2, 202320
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
May 2, 202321
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.
May 2, 202322
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
May 2, 202324
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
May 2, 202326
SOURCES OF DATA
R & D documents or Transferring site documents.Lab Note Book ( LNB)Trade JournalInternet Sourcing
Sources of data
May 2, 202327
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
May 2, 202328
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
May 2, 202329
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.
May 2, 202330
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.
May 2, 202331
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