Standard Operating Procedure for Analytical Method Transfer
Purpose:
The purpose of this procedure is to describe the various steps involved in the Analytical Method Transfer.
Scope:
This procedure is applicable to the analytical method transfers of Intermediate and Finished drug products, Active drug substances between Transferring site to Receiving site.
Responsibility:
It is the responsibility of the Transfer team from Transferring site (TS) and Receiving team from Receiving site (RS) to follow this SOP. The Transferring site is responsible to provide the entire set of documentation to the Receiving site.
| Sr. No. | Department | Responsibilities |
| 1. | Responsibilities of Transferring Site | 1. To provide method specific training to analysts and other involved personnel.2. To define all methods to be transferred for testing a given product.3. To define experimental design like AMTP, AMTR, Specification, MOA, specific sampling methods and their acceptance criteria (as applicable).4. To provide Analytical method validation reports for methods under transfer.5. To provide details of the Instruments, Equipment’s, standards, samples and other necessary requirements.6. To provide validated, approved procedures to be used during testing.7. To prepare and review transfer protocol and reports. |
| 2. | Responsibilities of Receiving site | 1. To review analytical methods provided by the transferring site and formally agree on acceptance criteria before execution of the transfer protocol.2. To ensure that the necessary instruments, equipment are available and qualified at the receiving site. The instruments, equipment to be used by the receiving site during transfer shall meet the appropriate specification to ensure the requirements of the method or specifications.3. To ensure that adequately trained, experienced and qualified analysts are in place for analytical testing.4. To properly execute the transfer protocol (as applicable)5. To support all relevant documentation required to conclude the analytical method transfer and to implement the final method.6. To generate and obtain approval of transfer reports along with Analytical data. |
| 3. | Quality Control | To prepare, review of protocol and Execution of Analytical method transfer. |
| 4. | Quality Assurance | To Review and Approval of Analytical method transfer protocol and report. |
Definition:
Analytical method transfer: It is the process of establishment of analytical test method at receiving site to judge the quality of a batch independently. The analytical method transfer also referred as method transfer, is the documented process that qualifies a laboratory (the receiving site) to use an analytical test procedure that originated in another laboratory (the transferring site), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended.
5.0 Procedure:
5.1 General Instructions:
5.1.2 Only validated analytical methods should be subject to an Analytical Method Transfer (AMT). Before the execution of the method transfer activity, the RS should receive and review the method validation report from the TS to confirm completion and compliance as per regulatory/guidelines requirements.
5.1.2 A formal gap assessment shall be done before the execution of the Analytical Method Transfer and will be documented. The analytical method transfer protocol shall include the details of method validations.
5.1.3 For exceptional cases, where validations are being performed at the transfer site, an approach of co-validation (i.e., performing intermediate precision at the receiving site) can be applied. In such cases, the approach should be well-defined in the validation protocol, and the protocol shall be approved by both sites. Such a method transfer should not be concluded until the completion of method validation. The conclusion about a successful method transfer should be reported in the validation report (approved by both sites). No separate AMTR is applicable here. A waiver report can be filed in such cases.
5.1.4 Key factors involved in a successful transfer of an analytical method include documentation, analytical data evaluation, information, communication, risk assessment, sample handling, storage, and training.
5.1.5. Analytical method transfer involves the following prerequisites,
– Analytical Method
– Specifications
– Method equivalency/ superiority report (Wherever applicable)
– Material Safety Data Sheets, if any
– Analytical method validation report and Method development report (as applicable).
– Gap assessment (whenever applicable)
5.1.6. Analytical method transfer protocol and report shall also have provision for details of Deviations from the protocol with the justification and investigation done during the method transfer.
5.2 Types of Transfers of Analytical procedures:
5.2.1 Analytical Method Transfer, also referred to as the Transfer of Analytical Procedures (TAP) or Method Transfer, is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (i.e., the transferring unit). This ensures that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended.
5.2.2 TAP or Method Transfer can be performed and demonstrated by several approaches.
5.2.3 Types of Transfers of Analytical procedures
· Comparative testing
· Co-validation between Two or More Laboratories
· Revalidation/Verification
· Transfer Waiver
5.2.3.1 Comparative Testing:
Comparative testing performed on homogeneous lots of the target material (i.e. standard production batches or samples intentionally prepared for the test e.g. by spiking relevant accurate amounts of known impurities into samples or as mentioned in the method transfer protocol.
Comparative testing requires the analysis of predetermined number of samples of the same lot by both the transferring and receiving units.
If the receiving unit meets a predetermined acceptance criterion for the recovery of an impurity in a spiked product. Such analysis is based on a preapproved transfer protocol and meeting the predetermined acceptance criteria is necessary to assure that the receiving unit is qualified to run the procedure.
5.2.3.2 Co-validation between Two or More Laboratories:
The complete or partial validation of analytical procedures by receiving unit. The laboratory that perform the validation of an analytical procedure is qualified to run the procedure.
The transferring unit can involve the receiving unit in a interlaboratory covalidation, including them as a part of the validation team at the transferring unit and thereby obtaining data for the assessment of reproducibility.
The above assessment shall be performed through preapproved transfer protocol that provides the details of the procedure, the samples to be used and predetermined acceptance criteria.
5.2.3.3 Revalidation /Verification:
Revalidation or partial revalidation is another acceptable approach for transfer of a validated procedure or as defined in preapproved method transfer protocol. Refer current edition of SOP for Analytical Method Validation And Verification and USP general chapter for validation of Compendial procedure (as applicable).
5.2.3.4 Transfer Waiver:
The Analytical method transfer or TAP may be omitted under certain circumstances. In such instances, the receiving unit is considered to be qualified to use the analytical procedures without comparison and generation of interlaboratory comparative data. Transfer waiver shall be justified in case of following scenario;
D-1: The new product composition is comparable to that of an existing product and /or the concentration of an active ingredient is similar to that of an existing product and is analyzed by procedure with which the receiving unit already has experience.
D-2: The analytical procedure being transferred is described in the USP-NF and is unchanged. Verification shall be applied in this case.
D-3: The analytical procedure transferred is the same as or very similar to procedure already in use.
D-4: The personnel in charge of the development, validation or routine analysis of the product at the transferring unit are moved to the receiving unit.
A report shall be prepared with justification for Analytical method transfer waiver. Refer attachment 3 for format.
5.2.4 Analytical method transfer is divided into following phases;
A. Receipt and Review of documents.
B. Gap Assessment
C. Preparation of Protocol
D. Approval of Protocol
E. Execution stage
F. Testing
G. Assessment of Results
H. Deviations / Investigations
I. Preparation of AMTR
J. Approval of AMTR
K. Post-transfer phase
5.3. Receipt and review of documents:
5.3.1. Detailed description of the analytical methods, specifications should be provided by the Transferring site (TS) to the Receiving site (RS). This includes the Method validation report of method to be transferred, detailed specification, method equivalency/superiority over official methods in case method under transfer are in-house and official monograph exists for the same.
5.3.2. Documents should be reviewed by the Receiving site with regard to the feasibility of performing the required analytical methods, e.g. equipment availability, capacity, experience.
5.3.3. The necessity of the analytical expert of the TS at the RS (or vice versa) for training purpose should be evaluated.
5.3.4. Preparing requisites like standards, samples, equipment’s or any other requirements as applicable etc.
5.4. Gap Assessment:
Gaps (if any) which are anticipated during method transfer should be assessed, documented (as per current edition of SOP, ‘GAP ASSESSMENT’, and should be reported in the analytical method transfer protocols. Identification of the critical element of a process which is available at TS but missing at the RS shall be assed in the gap assessment. E.g. System suitability procedures, instrument make/models, specific requirements from Transferring Site, training of personnel, Analytical Method validation report, Analytical data (as applicable).
5.5. Preparation of Protocol :
5.5.1. An Analytical method transfer protocol (AMTP) should be prepared by the transferring site. In exceptional cases where the transferring site is a API manufacturer, then the AMTP can be prepared by Receiving site. In case of client driven projects the preparation of AMTP/ AMTR etc. will be as per client requirements.
5.5.2. The AMTP shall contains the following,
5.5.2.1 Goal and scope:
The purpose of Analytical method transfer shall be defined appropriately to identify the details of experiment and cause of transfer. The objective of method transfer shall be defined appropriately with justification in the protocol.
5.5.2.2 Laboratory Involved:
The details of transferring site and Receiving site shall be define with detailed name of organizations.
5.5.2.3 Transfer Team:
The details of personnel of Transferring site and Receiving site involved shall be identified with their names and designation, department.
5.5.2.4 Document(s):
The details of documents required to perform analytical method transfer to be available at Transferring site and Receiving site shall be identified with document name and document code.
5.5.2.5 Instruments and Equipment:
The details of Instruments and equipment required for transfer shall be identified and listed.
5.5.2.6 Material(s):
The details of materials like but not limited to Reference standard/ Working standard/ Column details, Impurity standard, Placebo details, Test samples details.
5.5.2.7 Gap Assessment:
The brief detail of gap assessment shall be notified with reference in the gap assess report format. Identification of the critical element of a process which is available at TS but missing at the RS shall be assed in the gap assessment.
5.5.2.8 Site readiness of receiving site:
The Criticality of Analytical Methods shall be assessed to identify and specific requirement that the analytical method shall require transfer or not critical to perform method transfer.
For Example:
| Analytical methods | Critical | Not critical | Assessment/ comments |
| Average weight | X | √ | This test requires weighing of samples using analytical balance and calculation, hence no method transfer required. . |
5.5.2.9 Acceptance criteria:
The Acceptance criteria listed below should be derived according to method and are calculated on the basis of the specification. The minimum number of determinations for each test that needs to be carried out at RS is specified. It is possible to define different acceptance criteria, but these have to be justified based on analytical expertise (e.g. analytical values observed are very much below the specification, very hygroscopic or unstable analytical sample).
The following table shows the details of number test samples to be used:
| Analytical Test Methods | No. of Determinations1 | Acceptance criteria forRaw material, chemical intermediates, active pharmaceutical ingredients | Acceptance criteria forDrug product, pharmaceutical product, pharmaceutical intermediates |
| Identification | At each site 1 analyst x 1 Lot in 1 prepn. | Complies with specification | Complies with specification |
| Identification(IR) | At each site 1 analyst x 1 Lot in 1 prepn. | Results of TS and RS must comply with the specification and must be comparable. | Results of TS and RS must comply with the specification and must be comparable. |
| Identification(UV Spectrum) | At each site 1 analyst x 1 Lot in 1 prepn. | Results of TS and RS must comply with the specification ABS. Maxima observed at ± 3 nm or as per methodology. | Results of TS and RS must comply with the specification ABS. Maxima observed at ± 3 nm or as per methodology. |
| Dissolution test (Immediate release and(Extended release) | At each site 1 analyst x 1 Lot n= 6 per lot | Not Applicable | 1. The % release from six determinations should be within limits as specified in test method. 2. #For the comparisons of results of precision and method transfer, the absolute difference in the mean values of the dissolution results of both the parameters using the same strength does not exceed 10 % at time points with less than 85% dissolved and does not exceed 5% for time points above 85 % dissolved or Compare profile data (e. g. F2, Shall be more than 50). Note: Acceptance criteria may be product specific which can vary for different dosage forms for the same API also. Refer USP general chapter <711> OR individual set for Extended release. |
# Acceptance criteria may be product specific which can be vary for different dosage forms for the same API also and other statistical tests and limits may be used.
| AnalyticalTest Methods | No. of Determinations1 | Acceptance criteria For Raw material, chemical intermediates, active pharmaceutical ingredients | Acceptance criteria For Drug product, pharmaceutical product, pharmaceutical intermediates |
| Assay, Blend Assayand Uniformity of dosage unit by Content Uniformity, Preservative Content (By HPLC, GC, Titration) | At each site 1 analyst x 1 Lot in 6 replicate prepn. | The % RSD of 12 determination shall be £ 2.0% | 1. The % Assay, % Blend Assay or % preservative content from six determinations should be within limits as specified in test method.2. % RSD of six determinations should be not more than 2.0% for assay and Blend Assay and not more than 5.0% for preservative content.3. The %RSD of 12 determinations from precision study and method transfer activity study together should not be more than 2.0% and Blend Assay for assay and not more than 5.0% for preservative content. |
| For CU;At each site 1 analyst x 1 Lot in n=10 | 4. For Uniformity of dosage unit by Content Uniformity, the % content from ten determinations should meet the Pharmacopoeial requirements / specification for both sites. |
| Analytical Test Methods | No. of Determinations1 | Acceptance criteria For Raw material, chemical intermediates, active pharmaceutical ingredients, Drug product, pharmaceutical product, pharmaceutical intermediates |
| Residual Solvents3 | At each site 1 analyst x 1 Lot in 6 replicate prepn. | 1. The % RSD of the solvents in six spiked sample preparations should be NMT 15.0%.2. The overall % RSD from total 12 determinations (6 of precision and 6 of intermediate precision) should not be more than 15.0%.3.The Overall recovery of spiked sample shall be 80.0% to 120.0%. |
| Impurities 3 e.g. Related substances, enantiomer, Degradation product | At each site 1 analyst x 1 Lot in 6 replicate prepn. | %RSD limit for both individual and total impurities is tabulated in below table |
| Impurities Found | %RSD Limit for six determinations | %RSD Limit for six determinations for intermediate precision and 12 determinations for comparison of Receiving site and transferring site |
| Less than 0.05% or LOQ (whichever is higher) | Not to be reported | Not to be reported |
| ≤ 0.2% | Not more than 20.0% | Not more than 20.0% |
| > 0.2% | Not more than 10.0% | Not more than 10.0% |
$The overall recovery of spike sample shall be 80.0% to 120.0%
$ For Genotoxic impurities acceptance criteria will be defined as per pre-approved method transfer protocol/ proposed by transferring unit and receiving unit.
| Analytical Test Methods | No. of Determinations1 | Acceptance criteria For Raw material, chemical intermediates, active pharmaceutical ingredients, Drug product, pharmaceutical product, pharmaceutical intermediates |
| Water orLoss on drying | At each site 1 analyst x 1 Lot in 2 replicate prepn. | The % water content or Loss on drying should be within limits as specified in the test method.Not more than 3.0 % – Difference less than or equal to 0.5 % absolute3.0 % to 10.0 % – Difference less than or equal to 1.0 % absolute > 10.0 % – Individually set |
| Microbial test (MLT) | At each site 1 Lot | Conforms to pharmacopoeia requirements |
| Analytical Test Methods | No. of Determinations1 | Acceptance criteria for Cleaning validation by swab and rinse method |
| *Cleaning Validation | For swab and rinse analysis, 6 sample preparations at each site for 100% level for respective surface. | The % recovery of each individual sample at each level should not be less than 50% and not more than 125%.*Note: If the % recovery obtained at mentioned levels (even one sample at any level) is between 50% to 80% then a correction factor should be applied to calculate results in actual analysis. The results obtained with the test method should be multiplied with the correction factor. This correction factor should be incorporated in the MOA finalized after validation. (Correction factor = 100 / % recovery). |
1 Number of determinations carried out at TS and RS, more or less determination may be appropriate to prove successful method transfer depending on method complexity and/or criticality. The actual number of determinations chosen is set and justified in the AMTP.
2 A simple comparative analysis is insufficient if the samples chosen for the AMT contain an amount of impurity lower than the level of quantification. In such cases Stress batches or samples spiked with impurities can be used for the transfer analysis.
3 Limit of Detection, Limit of Quantitation and Specificity test can be included as transfer criteria as per requirement.
5.5.3. Draft AMTP should be carefully assessed by the Receiving site for the readiness of the Site with respect to the analytical method described. AMTP should be received from the TS and should have the provision for individual results data reporting of TS and RS.
5.5.4. After confirmation from the Receiving site, the AMTP should be approved and signed by the Transfer team of TS and RS.
Note:
1. All other transfers which are not mentioned in this SOP shall be performed as per the predefined protocol (as applicable).
2. Experimental procedures and acceptance criteria for any method transfer activity can be altered as per the predefined protocol on a case-to-case basis but should be scientifically justifiable (as applicable).
3. Method transfer shall be performed by QC analyst in presence of AMV analyst and AMV analyst will explain in detail about analytical methodology and hence, method transfer activity is considered as intermediate precision.
4. Addendum method transfer shall be performed on the basis of case to case and shall be performed as per the predefined addendum method transfer protocol.
5. In case of method transfer taken from other laboratory/vendor, the results shall be compared with manufacturer batch COA i.e. batch release COA from manufacturer. In this case the acceptance criteria will be as per preapproved method transfer protocol/as proposed by transferring unit and receiving unit.
5.6. Execution stage:
5.6.1. The following documents should be supplied by the transferring site to receiving site
· Relevant Specification (s), if applicable
· Relevant Standard Operating Procedure (s ), if applicable
· Material Safety Data Sheets, if applicable.
· Analytical Method : Detailed test procedure and its validation additional information on routine performance and behavior of concerned methods. may include development reports or other knowledge repositories, monitoring of SST, results or other data, control charts, unusual and OOS-results, information regarding calculation methods (decimal places, average calculation), acceptance criteria and specifications. Stability studies are an excellent source to evaluate the real routine performance of an analytical procedure.
5.6.2. The following material (s) should be transferred from transferring site to Receiving site
· Reference or Working standard
· Test sample (s)(with exceptions of pure analytical projects where test samples may be provided by clients)
· Reagent (s)/ columns if applicable (in case of difficulties in procuring at RS)
5.7. Testing
5.7.1. The testing program defined in the AMTP should be executed by the TS and RS accordingly.(Data already available at TS prior to start of AMT may be used if justified)
5.7.2. The testing program has to be finalized within a reasonable time frame by both TS and RS. The difference in time between testing performed at RS and TS should be scientifically justifiable, if not otherwise agreed the final assessment should be the responsibility of the TS.
5.7.3. The complete raw data should be retained within the site that conducted the analytical testing.
5.7.4. Necessary changes and adaptation in the method parameter should be discussed and documented by RS and TS.
5.8. Assessment of Results:
5.8.1. Assessment of all results is performed by the TS therefore the RS should submit the results of the tests including relevant raw data to the TS for the assessment.
5.8.2. Assessment should be finalized on the basis of results of TS and RS and the acceptance criteria in the AMTP.
5.8.3. If the acceptance criteria are not met, an investigation should be performed at both sites.
5.8.4. If complexity, robustness and/or reproducibility of the analytical methods are not sufficient for AMT, the analytical methods have to be improved. This should be discussed in detail in the Analytical method transfer report. (AMTR). A new AMT should be started with modified analytical methods.
5.9. Laboratory investigations or Incidences /Deviations.
5.9.1. All the Laboratory investigations and Deviations shall be routed through laboratory standard operating procedures.
5.9.2. All the Laboratory investigations and Deviations shall be thoroughly investigated to root cause identification, documented and justified.
5.9.3. The conclusions of Laboratory investigations and Deviations Shall address the required changes to transferring analytical methods and further related actions. Method re-evaluation shall be carried out on the basis conclusion of Deviation or Investigation. In such cases investigation at the TS shall be carried out for the failure of the method in spite of the successful method development.
5.10. Preparation of AMTR
5.10.1. After finalization of the assessment the Analytical method transfer report (AMTR) should be prepared by the TS.
5.10.2. AMTR should be prepared to document the activities performed during the AMT.
5.10.3. AMTR should contains the following,
5.10.3.1 Goal and Scope
The Analytical method transfer report shall describe complete details of product, strength, dosage from Transferring site to Receiving Site.
5.10.3.2 Laboratory Involved
The details of Transferring site and Receiving site shall be reported with detailed name of organizations.
5.10.3.3 Transfer Team
The details of personnel of Transferring site and Receiving site involved shall be reported with their names and designation, department.
5.10.3.4 Document(s)
The details of documents required to perform analytical method transfer to be available at Transferring site and Receiving site shall be reported with document name and document code.
5.10.3.5 Material(s)
The details of materials like Reference standard/ Working standard/ Impurity standard, Placebo details, Test samples used in method transfer shall be reported.
5.10.3.6 Training visit (If applicable)
The scope of training visit shall be reported with brief description. Details of the training visit shall be reported including the start date to the end date from TS at RS. SOP driven training records shall be generated and reported.
5.10.3.7 Acceptance criteria
The details of the test method under transfer shall be reported with their acceptance criteria.
For Example,
| Analytical methods | Experimental program | Acceptance criteria |
| Dissolution | 1Test each with 6 individual units at TS & RS | 1. The % release from six determinations should be within limits as specified in the test method.2. For the comparisons of results of precision and method transfer, the absolute difference in the mean values of the dissolution results of both the parameters using the same strength does not exceed 10 % at time points with less than 85% dissolved and does not exceed 5% for time points above 85 % dissolved.Note: Acceptance criteria may be product specific which can vary for different dosage forms for the same API also. Refer USP general chapter <711>. |
5.10.3.8 Experimental details and results
The experimental details and data results obtained during the transfer of the analytical method like Documentation of Raw data, Results of analytical method shall be reported.
Report the individual data of the RS as well as the TS for each test in the transfer report.
Example, for the test Dissolution results,
| Vessel No./Tablet No. | Transferring Analyst TSWith Name and detailsBatch No. details | Receiving Analyst RSWith Name and detailsBatch No. details |
| 1 | ||
| 2 | ||
| 3 | ||
| 4 | ||
| 5 | ||
| 6 | ||
| Mean | ||
| SD | ||
| %RSD | ||
| % absolute difference in Mean value |
| Result No. | Total of 12 units results of Analyst TS and Analyst RSBatch No. details |
| TS-1 | |
| TS-2 | |
| TS-3 | |
| TS-4 | |
| TS-5 | |
| TS-6 | |
| RS-1 | |
| RS-2 | |
| RS-3 | |
| RS-4 | |
| RS-5 | |
| RS-6 | |
| Mean | |
| SD | |
| %RSD |
5.10.3.9 Deviations:
Any deviation from the protocol shall be documented as per current SOP of deviation or incidence documentation. The deviation investigation shall be perform to justify the deviation from the transfer protocol and documented properly for root cause identification.
5.10.3.10 Investigation/ Incidences
Any investigation during the analytical method transfer shall be performed and reported as per current SOP of investigation. All the outcome of the investigation shall be documented and reported to the transferring site for further evaluations. The changes to analytical procedure shall be communicated from the transferring site to the receiving site based on the corrective action and preventive action of investigation and the same shall be reported.
5.10.3.11 Justification and Conclusion
Based on the root cause identification failure or approval of analytical method transfer shall be concluded and reported. Re-transfer of method shall be justified in case of failure of method transfer.
5.10.3.12 Follow up tasks
On successful completion of analytical method transfer follow up tasks for Transferring site and Receiving site shall be proposed such as but not limited to modifications in analytical procedures and method of analysis with suitable justifications.
5.10.3.13 Changes to the analytical methods
Required changes or proposed changes to the analytical procedure if any which are identified during the transfer of method, during investigation shall be reported in final analytical method transfer report.
5.10.3.14 Discussion and conclusion
Based on collective data, the final conclusion of analytical method transfer shall be reported. It includes deviations, investigation and analytical results compilation.
5.10.3.15 Comments/remarks
Any specific comments/remarks to address the final analytical method transfer shall be reported.
5.11. Approval of AMTR
The AMTR is approved and signed necessarily by the transfer team of TS and RS.
The approved version of the AMTR should be available within a reasonable time after performing the analytical tests. If no follow up tasks are required, AMT can be considered to be closed after AMTR approval.
5.12. Post-transfer Phase
5.11.1. During the post- transfer phase all follow up tasks stipulated in the AMTR are executed.
5.11.2. All changes and adaptations to the analytical methods should be assessed with regards to,
· Relevance for registration, If changes/adaptation have relevance to registration, a formalized Change control to be initiated.
· Validation status of the analytical methods. In case of changes or if modifications affect the validity of current validation, a revalidation of the analytical methods should be performed by RS. An AMT can be finalized after all follow up tasks are finalized. This should be approved by TS and RS.
References:
1. Current USP General Chapter < 1224 > Transfer of Analytical Procedures
2. Annex 7 WHO guidelines on transfer of technology in pharmaceutical manufacturing
6.0 Acceptance Criteria:
Not Applicable
7.0 Frequency:
Whenever method to be transfered from one site to another site
8.0 Format for recording:
8.1 Format for AMTP
PROTOCOL APPROVAL
| PREPARED BY: | Name and Designation, AMV | Sign:Date: |
| CHECKED BY | Name and Designation, AMV | Sign:Date: |
| CHECKED BY: | Name and Designation, QC | Sign:Date: |
| APPROVED BY: | Name and Designation ,Client/Transferring Site ( if applicable) | Sign:Date: |
| APPROVED BY: | Name and Designation , QA | Sign:Date: |
| 1. Goal and Scope |
| 2. Laboratories Involved |
| TS ( Company name, details) | RS (Company name, details) |
| 3. Transfer Team |
| Name | Department | Function |
| Transfer Team LeaderTransfer Analyst | TS | |
| Transfer Team LeaderTransfer Analyst | RS |
| 4. DocumentsThe following documents are prerequisite to perform the Analytical method transfer correctly. These documents have to be available to both, TS and RS, prior to start the Analytical Method Transfer |
| Document Name | Document code |
| 5. Instruments and EquipmentThe following equipment ( including e.g. HPLC column) has to be available for performing the analytical method: |
| 6. Material |
| 6.1 Reference Standard(s)/Working StandardThe following reference standard (s) ( including certificate of Analysis) are needed during the Analytical Method transfer. These substances have to be available to both TS and RS, prior to start of the AMT. |
| Name | Batch Number | Expiry Date | Storage condition | Remarks |
| 6.2 Placebo Samples(s)The following sample(s) (including suitable documents e.g. certificate of analysis) are needed during the analytical method transfer. These samples have to available to both TS and RS prior to start the AMT |
| Name | Batch Number | Expiry Date | Storage condition | Remarks |
| 6.3 The following test samples are going to be analyzed during the AMT. These test samples are provided by TS to RS prior to start of the AMT. |
| Name | Batch Number | Expiry Date | Storage condition | Remarks |
| 7. Gap assessment |
| 8. Site readiness of receiving siteThe RS reviewed the analytical methods. All equipment necessary for performing the analytical test is available and all pre requisition for the use of the equipment is fulfilled (eg. Qualification and calibration) All personnel are adequately trained and are familiar with the basic principal of the analytical methods described. Thus the RS is ready to receive the analytical methods. |
| 9. Criticality of Analytical methodsThe criticality of the analytical methods is evaluated in a risk assessment |
| Analytical methods | Critical | Not critical | Assessment/ comments |
| 10. Acceptance criteriaThe success of the Analytical method transfer will be assessed. The results obtained at both sites are set in relation to the acceptance criteria. |
| Test | Experimental program | Acceptance criteria | Remark |
8.2 Format for AMTR
| PREPARED BY: | Name and Designation, QC | Sign: Date: |
| CHECKED BY: | Name and Designation, QC | Sign: Date: |
| CHECKED BY: | Name and Designation, AMV | Sign: Date: |
| APPROVED BY: | Name and Designation, Client/Transferring site ( if applicable) | Sign: Date: |
| APPROVED BY: | Name and Designation , QA | Sign: Date: |
| 1. Goal and ScopeThis Analytical method transfer report describes the complete analytical method transfer of( Name of product, strength and dosage form) from TS to RS |
| 2. Laboratories Involved |
| TS (Company name , details) | RS (Company name , details) |
| 3. Transfer team |
| Name | Department | Function |
| Transfer team leaderTransfer Analyst | TS | |
| Transfer team leaderTransfer Analyst | RS |
| 4. DocumentsThe documents as defined in the analytical method transfer protocol have been used to perform the analytical method transfer. |
| 5. MaterialThe reference standards, placebo samples and test samples as defined in the analytical method transfer protocol were provided by TS to RS and have been used to perform the analytical method transfer. |
| 6. Training visit ( If applicable )A visit for training purposes by an expert of the TS took place from ( dd/mm/yy) to ( dd/mm/yy) at the RS. The scope of the visit was ( short description) |
| 7. Acceptance CriteriaThe acceptance criteria for the transfer of the analytical methods are: |
| Analytical methods | Experimental program | Acceptance criteria |
| 8. Experimental Details and Results: In the following the experimental details and results obtained during the transfer of the analytical methods are listed. |
| 8.1 Documentation of Raw DataThe complete documentation of the analytical testing including all raw data is under the control of the respective site. The reference to the documentation is: |
| TS | RS |
| 8.2 Results of the analytical method (1) |
| Parameters | Difference | Acceptance criteria | Results of assessment | ||
| 8.3 Results of the analytical method (2) |
| Parameters | Results of analysis TS | Results of analysis RS | Difference | Acceptance criteria | Results of assessment |
| 9. Deviation: |
| 10. Investigation: |
| 11. Justification and Conclusion: |
| 12. Follow up tasks During the analytical method transfer the following follow up tasks have been identified |
| Follow up tasks | Responsibility TS/RS |
| 13. Changes to the analytical methodsDuring the analytical method transfer the following changes to the analytical methods have been identified. |
| 14. Discussion and conclusionThe analytical method transfer was performed according to the established analytical method transfer protocol.All results comply with the respective acceptance criteria established.The transfer of the analytical methods for (name of product, strength and dosage form) is completed successfully. |
| 15. Comments/ Remarks |
8.3 Format for Analytical Method transfer waiver
| PREPARED BY: | Name and Designation, QC | Sign: Date: |
| CHECKED BY: | Name and Designation, QC | Sign: Date: |
| CHECKED BY: | Name and Designation, QA | Sign: Date: |
| APPROVED BY: | Name and Designation ,Client/Transferring site ( if applicable) | Sign: Date: |
| APPROVED BY: | Name and Designation , QA | Sign: Date: |
| 1. Methods for which transfer shall be waived off :- Product :- Test Method :- |
| 2. Justification for waiver |
