SOP for Technology Transfer of Analytical Procedure
1.0 OBJECTIVE:
To describe the procedure for the requirements and actions necessary to effectively plan and execute a successful transfer of technology of Analytical Procedure from transferring site to receiving.
2.0 SCOPE:
This SOP (Standard Operating Procedure) covers the procedure for transfer of analytical methods for testing from Analytical Development Laboratory (ADL) / Transferring Site to Receiving Site applicable at [Company name] .
3.0 RESPONSIBILITY:
3.1 [Company name] as receiving site:
3.1.1 Quality Control Personnel: To receive technical analytical document (TAD) for analytical method to be transfer through QA department / ADL, to check availability of requirements like column/reagents/any special requirement, Prepare Protocol to receive the Analytical Method.
3.2 [Company name] as transferring site:
3.2.1 Quality Assurance Personnel: To send minimum required document related to analytical method to be transferred.
3.2.2 Quality Control Personnel: To provide technical assistance / training regarding technology transfer to receiving site as per requirement of receiving site.
4.0 PROCEDURE :
Definition: The systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and/or commercialization to an appropriate, responsible and authorized party. This not only includes transfer of documentation but also includes the demonstration at the receiving unit to effectively carryout the critical elements of the transfer of technology.
4.1 Technology transfer for Analytical Method from ADL / Transferring Site to Quality Control (QC) site at [Company name]. (Drug Substance / Drug Product):
4.1.1 Method transfer shall be done either by Direct Method Transfer or Indirect Method Transfer.
4.1.2 Direct Method Transfer: Transfer of analytical methods involving analysis of common samples in which the analyst from Transferring Laboratory demonstrates the method to an analyst of the receiving laboratory at the same location.
4.1.3 Indirect method transfer: Transferring laboratory Analyst shall analyze the sample at Transferring laboratory and provide the results, chromatograms, all raw data and the sample to receiving QC laboratory Chemist. After the receipt of the sample, receiving QC chemist shall analyze the sample from the same batch and send back the chromatograms and the results to Transferring laboratory.
4.1.4 ADL / Transferring site shall provide the Receiving Laboratory (Site QC) with a detailed written approved method (Directly or through CQA) along with IR/UV spectra, HPLC/GC chromatograms and a list of reference / working standard and any specific laboratory chemicals required for analysis where ever applicable.
4.1.5 Analyst / Officer from receiving QC (Quality Control Site) Laboratory Analyst shall review the method and obtain all required chemicals, reagents, column, equipment etc. to conduct the testing prior to Method Transfer.
4.2 ADL / Transferring Laboratory Analyst and Receiving Analyst shall communicate to clarify the details of the method and to provide answer to questions regarding implementation of the Method need based. QC Head shall verify the compatibility of the QC chemist / Analyst who will receive the Technology Transfer.
4.2.1 Receiving Lab shall prepare protocol for Analytical Method Transfer. The same shall be reviewed and signed by both the laboratories prior to commencement of Method Transfer.
4.2.2 Protocol shall be prepared as per Annexure II.
Note: Annexure –II shall be used as guidance for the preparation of protocol, contents shall be changed as per the requirement
4.2.2.1 Protocol Numbering shall be as follows
[Company should decide the applicable numbering system]
4.2.3 Checklist of prerequisite shall be attached with each protocol as per Annexure I
4.2.4 Method Transfer shall be done by analyzing at-least two batches in case of API and Single Strength in Formulation. In case of product having two strengths, method transfer shall be done on both the strengths (One batch each). In case of multiple strengths (three or more than three), method transfer shall be done on one batch of each of lowest, highest as well as one strength of worst case scenario between lowest and highest (depending upon scale up/down and look alike status of strengths) may be considered.
4.2.5 If test for Assay and Content Uniformity are transferred by the same analytical method then only Assay shall be demonstrated and reported to the Receiving Laboratory.
4.2.6 Results of both the analysts shall be considered equivalent if they meet the predetermined acceptance criteria specified in the method transfer protocol.
4.2.7 If all the results are comparable and meet the acceptance criteria then Technology Transfer Report shall be prepared as per Annexure III and same shall be approved by both laboratories, documenting that the method transfer has been successfully completed. A copy of the Technology Transfer report along with protocol shall be maintained by both laboratories.
4.2.8 Any deviation in the process of method transfer shall be discussed. A deviation report has to be written jointly with proper justification.
4.2.9 If any of the acceptance criteria included in the Technology Transfer Protocol is not met then Transferring laboratory analyst shall troubleshoot the method and demonstrate once again. The complete process shall be repeated at the Receiving laboratory. The new data shall be re-evaluated using same acceptance criteria.
4.2.10 If the acceptance criteria are not met for specifications, an investigation shall be done to look for any ambiguity.
4.3 Technology transfer for Analytical Method from Quality Control site at [Company name] to Other Quality Control site. (Drug Substance / Drug Product):
4.3.1 Transferring site shall provide the Receiving Laboratory with a detailed written approved method directly or Receiving Laboratory can get same through CQA along with IR/UV spectra, HPLC/GC chromatograms and a list of reference / working standard and any specific laboratory chemicals required for analysis where ever applicable.
4.3.2 Method Transfer shall be done as either direct method or indirect method.
4.3.3 Documentation and policies shall vary depending on receiving laboratory requirement.
4.3.4 Execution of Technology transfer activity shall be done as per receiving site procedure.
5.0 ANNEXURES :
Annexure I Prerequisite for Technology Transfer
Annexure II Technology Transfer Protocol for Analytical Methods of [Product / Material Name]
Annexure III Technology Transfer Report for Analytical Methods of [Product / Material Name]
Annexure I Prerequisite for Technology Transfer
Note: Check for availability
1. Method to be transferred
2. Detail method of analysis of each test
3. Equipment / Instrument
4. Working standard
5. Impurity standards
6. HPLC column (s)
7. GC column (s)
8. Specific Chemicals
Analyst (Transferring Laboratory)
Analyst (Receiving Laboratory)
Annexure II TECHNOLOGY TRANSFER PROTOCOL FOR ANALYTICAL METHODS OF [Product / Material Name]
1. Index
1.0 Index
2.0 Protocol Approval
3.0 Acceptance Criteria Approval
4.0 Experimental Design
5.0 Technology Transfer Certificate / Report Approval
6.0 Training Details
7.0 Investigation report for Devotion during Method Transfer (If any)
2. Protocol Approval
Protocol Number
Protocol Prepared By
Protocol Checked By
Protocol Approved By
Head Transferring Lab
Head QC
Head QA
Date of Issue
3. Acceptance Criteria Approval
Direct / Indirect Technology Transfer
Protocol No:
Product /Material:
Product / Material Code:
Method Reference No. ___________ Rev. No.:______ Date: _______
Transferring Laboratory (A):
Receiving Laboratory (B):
1) Batch No. / LOT No. ____________________
Label Claim: _________________
2) Batch No. / LOT No. ____________________
Label Claim: _________________
Test
Number of Replicates
Acceptance Criteria
Comments /Remarks: ____________________________________________________________________________________________________________________________________________
Analyst
(Transferring Laboratory)
Analyst(Receiving Laboratory)
Head Transferring Laboratory
Head Quality Control [Receiving Laboratory]
Head Quality Assurance [Receiving Laboratory]
4. Experimental Design
5. Technology Transfer Certificate / Report Approval
Location
Date
Product Code
Method Reference
Product
Batch No.
The analytical Method for above product has been successfully Transferred / Not Transferred
To:
[Receiving Laboratory]
[Analyst Name]
[Signature]
By:
[Transferring Laboratory]
[Analyst Name]
[Signature]
Approved By: Head QC:
[Receiving Laboratory]
Approved By: Head QA:
[Receiving Laboratory]
Approved By: Head:
[Transferring Laboratory]
6. Training Details
Name of the Trainer
(Transferring Laboratory)
Name of receiving Analyst
LocationDuration & Dates
Product Name
Methods
Method Reference
Satisfactory / Not Satisfactory
Following are the practical tips :1)
Name of the Trainee
(Receiving Laboratory)
Sign/Date
Training Found Satisfactory / Not Satisfactory :
Approved by
Quality Assurance
Head Transferring Laboratory
7. Investigation report for Deviation during Method Transfer (If any)
Section – I ( completed by requestor) Requestor : Analyst (Transferring Analyst)
Requestor Name :
Dept. :
Date :
Analytical method Reference:
Rev No.
Effective Date :
Deviation Details
Deviation For
Justification for deviation
Method
Specification
Instrument
Products / Associated Documents Affected
Attachment
Department Head Approval
Date :
[Transferring Laboratory]
Section II : Deviation Impact (Receiving Lab – Quality Assurance)
Does deviation make a significant impact on quality
Yes
No
Is validation required
Yes
No
Comment :
Quality Assurance / Date :
Section III (completed by reviewer)
Reviewed By
[QC receiving Laboratory]
[QA receiving Laboratory]
[Analyst Transferring Laboratory]
Section IV : Approvals
Head QC
Date :
Head QA.
Date :
Head Transferring Laboratory
Date :
Section V : Verification of pending activities completed (Completed by QA)
Pending Activities
Completion Date
Comment :
Head Q A Signature:
Date :
Annexure III
TECHNOLOGY TRANSFER REPORT FOR ANALYTICAL METHODS
OF
[Product / Material Name]
Location :
Date :
Product Code :
Method Reference :
Product :
Test
Number of Replicates
Acceptance Criteria
Result
The analytical method for the above product has been successfully Transferred / not Transferred
Analyst [Transferring Laboratory]
Analyst [Receiving Laboratory]
Head Quality Assurance [Receiving Laboratory]
Head Quality Assurance [Transferring Laboratory]