sop for Technology Transfer

1.0 Objective
To lay down a procedure for technology transfer from R&D and other locations to plant.
2.0 Scope
This Standard Operating Procedure is applicable for technology transfer from R & D and other

locations to plant to be followed at abc Pvt. Ltd.
3.0 Responsibility
3.1 R & D person / other location person shall be responsible for transfer of product manufacturing

technology and related documents to abc location.
3.2 Officer / Executive QA shall be responsible for review of documents received from R&D

and from other location. Officer / Executive QA shall responsible for preparation of other

master documents required for technology transfer.
3.3 Production Manager or his/her designee shall be responsible for monitoring of process as

per formula and necessary arrangement required for technology transfer.
3.4 Head / In charge Q.A. or his/ her designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
IPQA : In process Quality Assurance
BPCR : Batch Production and Control Record
R&D : Research & Development
MFR : Master Formula Record
STP : Standard Testing Procedure
5.0 Procedure
5.1 Corporate QA in consultation with R&D shall inform to plant QA / Plant-Head

regarding the transfer of product.
5.2 R&D shall designate competent person for transfer of product and designated person
shall be available at plant at the time of manufacturing.
5.3 R&D person shall hand over the all documents to plant QA related to product as per
Annexure- 1.
5.4 QA Officer / Executive shall verify the documents as per Annexure-1. If any non
availability of documents found and if any mistakes found, then same shall be informed
to R&D person for correction.
5.5 After receiving the corrected documents, QA Officer / Executive shall distribute the
documents to other concerned departments for reference and necessary arrangements.
5.6 Plant QA Officer / Executive shall prepare the Master BPCR based on TMFR which is
received from R&D.
5.7 QC Officer / Executive shall prepare the RM specifications, PM specification, In process
and Finished Product Specification, STP based on the documents received from R&D.
5.8 Production and R&D person shall ensure the availability of equipments, materials and
Other process requirements for the manufacturing of batch.
5.9 Initial two batches of a product will be considered as technology transfer batches.
5.10 During manufacturing if any changes are done by R&D scientist then same shall be
documented using a single deviation form and technology transfer report

(Refer Annexure-2) in consultation with production and QA.
5.11 After successful completion of two batches upto packing stage, technology transfer
report shall be prepared by the R&D as per Annexure-2.
5.12 Analytical methods for raw material, in process and finished product shall be verified by
QC department in presence of R&D scientist.
5.13 Decision for final Authorization of technology transfer report shall be taken plant Head-
QA. If he/ she has the opinion that one or two more batches are required to monitored
then QA-Head shall also recommend the same for taking the batches in the technology
transfer batches.
5.14 Each technology transfer report shall be assigned a unique alphanumeric code which
shall be as TTR/YYY where;
TTR – represents Technology Transfer Report
YYY – denotes serial no. starting from 001 i.e. first technology transfer report number
shall be TTR/001.
5.15 Final signed copy shall be retained by documentation cell- QA and a copy of this shall
be given to R&D.
5.16 On the basis of this technology transfer report R&D will have to revise the TMFR to
incorporate the changes and a copy of final revised TMFR will be circulated to plant QA
for their reference.
5.17 Upon receipt of revised TMFR from R&D, plant QA have to revise their relevant
product BPCR through proper change control procedure as per sop
6.0 Forms and Records
6.1 List of Documents – Annexure- 1
6.2 Technology Transfer Report – Annexure-2
7.0 Distribution:
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance , Quality Control , Production & R&D
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

sop for Technology Transfer

Reason for Revision

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