SOP on the Transfer of Technology for Analytical Method

  • Objective:
    • To lay down the procedure for Transfer of Technology for Analytical Methods.
  • Scope:
    • This procedure is applicable for Transfer of technology for Analytical Methods from ARD to Formulation Unit.
  • Responsibility:
    • Responsibility of Sending Unit (ARD ) are :
      • Preparation of Technology transfer Protocol for Analytical Method transfer.
      • Execution of training for carrying out the Analytical Method transfer successfully.
      • For providing reference standard/Working standards required for Analysis of the product.
      • To define the acceptance criteria and the limits for different parameters.
      • To review results and prepare the final Method transfer Report.
    • Responsibility of Receiving unit (Quality Control Lab. ) are :
      • To ensure availability of Instruments and reagents required for Technology transfer.
      • Execution of Protocol for Analytical Method transfer.
      • To ensure availability of calculation worksheets and other related documents required for  analysis of Batches.
      • Management of Deviations and change controls.
      • To ensure receipt of reference standard / working standards, product specifications, method of Analysis, approved Technology transfer protocol.
      • Ensure the availability of test samples for Analysis.
    • Sending unit and the receiving unit shall be jointly responsible for preparing the final report.
  • Accountability:
    • Head of Quality assurance & ARD is accountable for compliance of Analytical Method transfer and approval of Analytical method transfer report.
  • Procedure:
    • Reasons for Analytical Technology transfer can be following :
      • New product developed at ARD to be commercialized and analyzed in the QC Lab.
      • New analytical method developed for cost effective /economic or any other reasons.
    • In case of formulation unit  QC analyst participate in analytical methods validation activity performed at ARD, then there is no need for method transfer
    • When this new product received for analysis at unit VI, the analyst who had participated in analytical method validation activity shall demonstrate analytical method to other QC analysts of formulation Unit by performing first analysis
    • The following methods shall require Laboratory to Laboratory transfer for Analytical method
      • Assay and related substance method for active pharmaceutical ingredients (in case of non-pharmacopoeia methods)
      • Assay and related substance method for Finished products
      • Dissolution Method.
    • Process of transferring the technology used in Analysis for the Product manufactured from one location to another location to give consistent quality is termed as Technology transfer.
    • Sending Unit: ARD  that is actually transferring the technology from its site to formulation unit.
    • Receiving Unit: Quality Control Laboratory of manufacturing site that is receiving the Analytical method is formulation unit.
    • Proposal for the initiation of Analytical Method transfer shall be carried out by Head of ARD department or his designee.
    • ARD shall coordinate for the collection of all relevant documents  during Analytical Method transfer between Sending and Receiving unit.
    • FARD shall coordinate for the receipt of comments from all relevant department involved in Analytical Method transfer.
    • Upon receipt of comments from all relevant departments, QA department shall review and evaluate the comments of each department. He shall approve or reject the proposal of technology transfer on the basis of his evaluation.
    • ARD shall hand over the documents to Quality Assurance department of  formulation Unit.
    • On receipt of all relevant documents , QA of the receiving unit shall review the documents and execute the technology transfer.
    • ARD shall prepare the Analytical method transfer Protocol.
    • Analytical Performance parameters: The following Analytical Parameters to be carried out during Lab to Lab Analytical Method transfer.
      • For Assay and Dissolution:
        • Repeatability: System Precision , method precision and Intermediate Precision
      • For related Substances:
  •  Repeatability: System Precision, method precision and Intermediate Precision.
  • LOD and LOQ verification
  • QA of receiver site shall inform to Sending Unit for any other requirement during receipt of the Technology at receiver site.
  • QA shall give Final Clearance for the Analytical method transfer only after ensuring the GLP compliance and other requirements.
  • ARD in co-ordination with receiving site shall send the Analyst from Sending unit to the receiving unit for Execution of Analytical Method Transfer.
  • The analyst from ARD shall perform the analysis as per the approved protocol and report the results to the Head QC at receiving unit.
  • After completion of Analysis by the ARD analyst, analyst from QC of Receiving site shall repeat the analysis and report the results as per the format mentioned in the protocol.
  • QA of receiver’s site shall ensure that the Analysis of the drug product at QC shall be carried out as per approved procedures.
  • After the completion of Analysis of drug product at receiver’s site, QA of receiver site shall review all the raw data generated in the analysis of product during the Analytical method transfer.
  • Report for Analytical method transfer shall be generated by the ARD Analyst.
  • A Summary reports for the Analytical method transfer of drug product shall be prepared by Technology Group and shall be reviewed by QA and QC of receiver site and approved by Head QA.
  • Success Criteria for Analytical Method transfer: Analytical method Transfer shall be considered successful if results obtained by the analysis performed during method transfer, lies within the predetermined acceptance criteria as per the Approved protocol.
  • List of Annexure / Formats:
  • Proposal for initiation of Analytical Method Transfer
  • Check list for technology transfer.
  • References (if any).
    • SOP on SOP.
  • Reason for Revision:
    • Periodic Revision
  • Abbreviation:
    • SOP : Standard Operating Procedure
    • QC : Quality Control
    • SP : Specific
    • ARD :Formulation Analytical Research and Development
    • QA : Quality Assurance
    • cGMP : current Good Manufacturing Practice.
    • RA : Regulatory Affairs
    • GLP : Good Laboratory Practice

 

Annexure – I

  • Proposal for initiation of Analytical Method Transfer

PROPOSAL FOR INITIATION OF ANALYTICAL METHOD TRANSFER

 

Product Details
Type of Technology Transfer : Analytical method
Generic Name: Dosage Form:
Dedicated Facility required: Markets to be supplied:
Any specific or special Storage conditions for samples to be analyzed:
Specific requirement of Quality control Lab.
Analytical Methods to be transferred
Instruments and Equipments required :
Comments:

Forwarded by………………………….on…………………………..

A R D Confirmation
Product related Specific instructions if any:
Comments: –

Sign/Date :

Quality Assurance Confirmation
Comments:

Sign/Date :

Quality Control Confirmation :
Working Standard I Instruments I Columns
Availability Analytical Method Validation & action plan
Comments:

Sign/Date :

Receiving Unit QA Head Evaluation :
Comments:
NAME
SIGNATURE  

 

DATE

 

Annexure – II

  • Check list for technology transfer.

Date:

Receiving Unit:

Sending Unit:                                   

Product:                                

Sr. No.

 

Documents

 

Documents Received from Donor’s site &
Re-formatted for Receiver’s site
Justification if content of
reformatted receiver’s
documents differ from
donor’s documents
by QA
Yes

 

No

 

Not applicable
1 List of Analytical requirements / Instruments used in quality control laboratory.
2 Specifications and standard test procedures of Active Pharmaceutical ingredient
3 Specifications and standard test Procedures for Excipient.
4 Specifications and standard test Procedures for Packaging Materials.
5 Specifications and standard test Procedures for In-process and finished drug Product

 

6 Analytical method validation of Active Pharmaceutical Ingredient, In-process and Finished drug product  

 

7 Stability study specifications and standard test procedure.
8 Package inserts.
9 Drug product sample for comparison studies along with certificate of analysis.

Prepared By                                                        Checked By

Sign/Date :                                                           Sign/Date       :

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