Follow
1.0 Objective
To provide guidelines for the transfer of analytical methods for testing of raw materials and finished products to site laboratories where the routine testing shall be carried out including the training of the concerned analyst and proper documentation.
2.0 Scope
This procedure is applicable to all analytical methods of drug substances like Assay, Related substances, Particle size distribution & Residual solvents and analytical methods of finished products like Assay, Related substances & Dissolution being transferred from one laboratory to another laboratory. Transfer may occur from R&D Lab., Site lab, Customer lab, Supplier or from other sites.
3.0 Responsibility
3.1 Transferring unit is responsible for providing the specifications, analytical procedure, the reference standards, the validation reports, and any necessary document, as well as for providing the necessary training and assistance to the receiving unit as needed during the method transfer.
3.2 Receiving site and Transferring site are responsible for preparing, reviewing and approving the protocol and report of analytical method transfer.
3.3 QA/QC of the receiving site and transferring site is responsible for authorizing the protocol and report.
3.4 Receiving site and Transferring site shall be responsible to ensure that transfer of analytical method from transfer lab is successfully done.
3.5 Manager QC of the receiving lab shall be responsible for effective implementation and training of procedure.
4.0 Accountability
4.1 Executive Director, Quality
5.0 Precautions
5.1 Maintain the confidentiality for all kinds of analytical method transfer process.
5.2 Change control procedure to be followed for any kind of changes during the analytical method transfer process.
6.0 Procedure
6.1 Definitions
6.1.1 Method transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferring analytical procedure as intended.
6.1.2 Transfer unit/lab is the site, which develops & validates the analytical methods and subsequently transfers to the user lab (receiving lab) for analysis of routine finished product or API batches.
6.2 Types of Transfers
6.2.1 Comparative testing
Comparative testing requires the analysis of a predetermined number of samples of the same lot by both the sending and receiving unit. Comparative study will be performed based on preapproved transfer protocol that stipulates the details of the test procedure, the samples that will be used and the acceptance criteria.
6.2.2 Co-validation Between Two or More Laboratories
The laboratory that performs the validation of the analytical procedure is qualified to run the procedure. The transferring unit can involve the receiving unit in an inter-laboratory co-validation including them as a part of the validation team at the transferring unit and thereby obtaining data for the assessment of reproducibility (Reproducibility expresses the precision between laboratories at different days, different analysts, different equipment with sample from same batch/ lot etc.). Co-validation study will be performed based on preapproved validation protocol that stipulates the details of the test procedure, the samples that will be used and the acceptance criteria.
6.2.3 Revalidation
Revalidation or partial revalidation is another approach for transfer of a validated test procedure. The following validation characteristics regarded as the most important for the partial revalidation of different types of analytical procedures.
• System suitability
• Specificity
• Linearity
• Limit of Detection
• Limit of Quantitation
• Precision
• Accuracy
6.3 Procedure
6.3.1 Procedure for Intra Site Method Transfer
Transfer of the analytical method from (Company Name), QC Track-I and R&D Laboratory (Transferor) to (Company Name), QC Track-II (Transferee).
6.3.1.1 (Company Name), QC Track-I and R&D are within the same premises. In case of this type of transfer, Transferor (QC, Track-I/R&D) will prepare transfer/validation protocol based on the methodology (Refer: 6.2.2 or 6.2.3) as appropriate which will be mutually agreed and signed by both transferor and transferee. Finally the protocol will be approved by head quality.
6.3.1.2 After completion of the analytical activities the report will be prepared by compiling the data obtained during analysis at both ends. Finally the report will be signed by R&D, QC & QA and analytical method transfer certification will be declared.
6.3.2 Procedure for Inter Site Method Transfer
Transfer of the analytical method from Customer lab, Supplier or from other sites (Transferor) to Quality Control laboratory of (Company Name), Track – II (Transferee).
6.3.2.1 Direct transfer from Supplier/Manufacturer (Transferor) to Quality Control laboratory of (Company Name), Track –II (Transferee).
6.3.2.1.1 In case of this type of transfer, Transferee (Receiving site) will prepare protocol based on the method received from Transferor and send to Transferor for their acceptance and signing. After signing of the protocol at both ends, the both sites will perform analysis as per the protocol at their own laboratories.
6.3.2.1.2 After completion of the analytical activities the report will be prepared by compiling the data obtained at both ends. In this case, all the acceptance criteria has to be met and be comparable.
6.3.2.1.3 Finally the report will be signed by both Transferor & Transferee and analytical method transfer certification will be declared.
6.3.2.2 Indirect transfer from Supplier/Manufacturer (Transferor) to Quality Control laboratory of (Company Name), Track –II (Transferee).
6.3.2.2.1 In case of this type of transfer, Transferee will prepare protocol based on the method and analytical method validation data received from Transferor. After approval of the protocol by Transferor and Transferee or QC/QA of Transferee. Receiving laboratory will perform analysis as per the protocol.
6.3.2.2.2 After completion of the analytical activities the report will be prepared compiling the analytical data and the data obtained from analytical method validation report of Supplier/Manufacturer (Transferor). In this case, all the acceptance criteria including comparative batch analysis results has to be met and be comparable with Supplier/Manufacturer analytical method validation data and CoA.
6.3.2.2.3 Finally the report will be signed and approved by Transferor and Transferee or QC/QA of Transferee.
6.3.2.3 Transfer from Supplier / Manufacturer (Transferor) to Quality Control laboratory of (Company Name), Track – II (Transferee).
6.3.2.3.1 In case of this type of transfer, Transferor will prepare protocol and send to Transferee for their acceptance and signing. After signing of the protocol at both end, the both sites will perform analysis as per the protocol at their own laboratories.
6.3.2.3.2 After completion of the analytical activities the report will be prepared compiling the data obtained at both ends.
6.3.2.3.3 Finally the report will be signed by both Transferor & Transferee and analytical method transfer certification will be declared.
6.4 For transferring of test procedure as per procedure no: 6.3.2.1 & 6.3.2.2 QC/QA shall issue the protocol number as per the SOP for ‘Document Numbering’ (QA002) and maintain the log register (Annexure – I).
6.4.1 Acceptance criteria for successful method transfer
The transfer acceptance criteria would be based on the method performance (Historical data from stability and release results, method validation report).
6.4.2 Deviations during method transfer
Any deviations should be thoroughly documented and justified. If the acceptance criteria are met, the method transfer is successful and the receiving unit is qualified to run the procedure. Otherwise, the procedure cannot be considered transferred until effective remedial steps are adopted in order to meet the acceptance criteria.
6.4.3 Training
Receiving site should provide training to the analyst to perform the analysis perfectly. Training should be documented.
