To lay down a procedure for technology transfer of New products .
The scope of this SOP is to all the new Products for which Technology has been provided by outside party or from R&D.
Head of Production, QA Head, QC Head shall be responsible to follow the procedure mentioned in this SOP.
Quality Assurance Head shall be accountable for compliance of the procedure mentioned in this SOP.
Whenever any new product is to be taken at company & the technology has been provided by some outside party or R&D. this procedure is to be followed.
The technology transfer is either done in house or outside party who has given the technology.
Since the Tech Transfer data is provided on the laboratory scale batches & the product is to be taken on large scale, it may be required that some changes in Process parameters or Quality parameters need to be changed.
A Batch Mfg. Record is prepared based on the Process given in Tech Transfer Documents.
A Validation Protocol is prepared based on Tech Transfer documents.
A Batch manufacturing is started in presence of QA
Each process parameter is monitored minutely.
Samples are drawn at each stage of Manufacturing from multiple locations & are tested for the required parameters.
In case any changes need to be made in process parameters, these are recoded on BMRs
After getting satisfactory results from QC, next stage is processed. In case any QC parameters need to be changed, they are recorded on the Result sheets.
If the batch is found to be OK at all stages including the final product, then next batch is taken.
The second batch is then processed as per the changes made in first batch & if all the parameters are within specifications, third batch is taken.
All the 3 batches are kept on stability at Long Term & Accelerated.
A new version of BMR is made in case of any changes made in first 3 commercial batches.
A Validation Report is made for 3 batches & the data collected to see the impact of the parameters & the changes made.
Based on the Validation Report, the process is frozen & then if it has to undergo any change, it has to go through the Change Control Process.
Tech Transfer: Technology Transfer
QA: Quality Assurance
QC: Quality Control
BMR: Batch Manufacturing Record
HISTORY OF REVISION:
Reason for Revision
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube