by 1.0 OBJECTIVE
To lay down the procedure for transfer the analytical method from originating laboratory to receiving laboratory
2.0 SCOPE
This procedure is applicable for step in the analytical method technology transfer and acceptance criteria from originating laboratory .
3.0 RESPONSIBILITY
Executive – QC
4.0 DISTRIBUTION
Master copy : Quality Assurance Department
Controlled copy – 1 : Quality Control Department
5.0 PROCEDURE:
- If technology transfer is performed by originating laboratory and receiving laboratories follow the below procedure:
- Prepare the analytical method transfer protocol according and numbering of protocol as per below:
ABC /QC/AMTP/YY/XXX
ABC= Name of company
QC= Quality control
AMTP=Analytical method transfer protocol
YY= current year
XXX=Serial number
- The sample tested by both the laboratories should be same.
- Test the sample according to analytical method (from originating laboratory).
- Test which is to be performed should be analyzed in triplicate.
- Our laboratory must be use instruments that are equivalent to originating laboratory.
- Both the laboratory should meet the required test parameter as specified in the approved specification.
- All the system suitability parameter which is in the test procedure should meet the requirement in both laboratory.
- All the observation record in analytical method transfer report according And numbering of report as per below:
ABC/QC/AMTR/YY/XXX
ABC= Name of company
QC= Quality control
AMTR=Analytical method transfer report
YY= current year
XXX=Serial number
- Acceptance variation limit should be meet .
- After completion of analytical method transfer a technology transfer certificate shall be issued .
- If the technology transfer is performed separately by originating laboratory and receiving laboratory follow the protocol and procedure of originating laboratory.
- When there is no originating laboratory for technology transfer follow the below procedure;
- At least two different batches with same strength of a product along with certificate of analysis required from transfer site for analysis.
- Method of analysis required for analysis from transfer site.
- Performed the complete analysis as per specification, standard test procedure at quality control department according to method of analysis received from transfer site.
- After completion of analysis all test parameters results are to be summarized with test name and results.
- Comparison studies containing results of analysis of Quantitative tests performed by both laboratories will be provided as per the format given if required / demanded.
6.0 ABBREVIATIONS
QC : Quality Control
SOP : Standard Operating Procedure
No. : Number
