Follow
1.0 OBJECTIVE
To lay down a procedure for Technology Transfer of products from one site to another site.
2.0 SCOPE
This SOP is applicable to the products to be transferred from Track-I/Sending unit to (Compnay Name).
3.0 RESPONSIBILITY
3.1 Concerned R&D/QA Head of Receiving Unit shall be responsible to ensure that Transfer of Technology from Sending Unit to Receiving Unit is successfully done.
3.2 QA/R&D/Production of receiving unit shall be responsible for effective implementation and monitoring of procedure.
3.3 Receiving unit is responsible for preparation of the product technology transferprotocol & report.
3.4 Receiving unit & Sending unit are responsible for reviewing & approval of the product technology transfer protocol & report.
4.0 ACCOUNTABILITY
4.1 Executive Director, Manufacturing / Executive Director, Quality.
5.0 PRECAUTIONS
5.1 Maintain the confidentiality for all kinds of product technology transfer process.
5.2 Change control procedure to be followed for any kind of changes during the Technology transfer process.
6.0 PROCEDURE
6.1 Technology Transfer
A documented evidence to transfer the chemistry, manufacturing, packing & analytical methods of existing products from one location to another location to maintain consistent performances of the process / methods that the quality of the transferred products remain unchanged.
Technology transfer can occur between:
i) R&D department and manufacturing site of Beximco Pharmaceuticals Limited.
ii) Beximco Pharmaceuticals Limited and other manufacturing sites.
The same procedure will be followed for both the cases and the data covering for Technology transfer is of development, Production and Quality control. The unit managing the process will be describing in the Technology transfer protocol.
6.2 Before starting the product Transfer, Receiving unit shall ensure that following documents are received from the Sending Unit.
6.2.1 Product details.
6.2.2 Tentative Raw Material Requirement.
6.2.3 Tooling Details (Change Parts).
6.2.4 Raw Material Specification.
6.2.5 Intermediate Product Specification.
6.2.6 Finished Product Specification.
6.2.7 Method of Analysis (STP) – Raw Material.
6.2.8 Method of Analysis (STP) – Finished Product.
6.2.9 Master Formula Record / Copy of BMR.
6.2.10 Master Packaging Docket / Copy of BPR.
6.2.11 Packaging Material Specification.
6.2.12 Reference Standards for Raw Material.
6.2.13 Analytical Method Validation Summary Report.
6.2.14 Process Validation Summary Report.
6.2.15 Stability Study Summary Report.
6.2.16 Bioequivalence (BE) study Report.
6.2.17 Approved / Control Sample of any Current batch.
6.3 The Technology Transfer is divided in different categories as mentioned below:
6.3.1 Technology Transfer of products from Track – I (Sending Unit) to Track – II (Receiving Unit) for existing products/new products.
6.3.2 Technology Transfer from other than Track – I (Sending Unit) to Track – II (Receiving Unit) for existing products/new products.
6.4 Procedure of Technology Transfer from one site to another site
6.4.1 Technology Transfer Team comprising of representative from Production, QA, Validation, R&D/Regulatory Affairs, Engineering and QC department in receiving unit and Technical experts of Sending unit.
6.4.2 QA/R&D of receiving unit shall prepare a technology transfer Protocol as per the Annexure – V & Report as per the Annexure – VI. For technology transfer protocol and report QA shall issue the protocol and report number and maintain the log register (Annexure – IV).
The unique document number for product technology transfer protocol shall consist of 11 characters, broken down as follows –
( – – – ) ( / ) (- – -) ( / ) ( – – – )
Document Code Slash Product code Slash Sequential No.
Document identification codes for product technology transfer protocols (3 alphabetical characters) as defined below.
For product technology transfer protocol of NAPA Tablets shall be
e.g. TTP/NAT/001 Where,
TTP is the code of product Technology Transfer Protocol / is separator
NAT is the product code of Napa tablets / is the separator 001 is the sequential number starting from 001, 002 & so on.
The unique document number for product technology transfer reports shall consist of 11 characters, broken down as follows –
( – – – ) ( / ) (- – -) ( / ) ( – – – )
Document Code Slash Product code Slash Sequential No.
For product technology transfer report of NAPA tablets shall be
e.g. TTR/NAT/001 Where,
TTR is the code of product Technology Transfer Report / is separator
NAT is the product code of Napa tablets / is the separator
001 is the sequential number starting from 001, 002 & so on.
6.4.3 R&D/QA of Track – II (receiving unit) shall request to R&D department of Track – I (sending unit) for technology transfer documents as mentioned in Annexure – I and same shall be verified by R&D/QA (Track – II).
6.4.4 In case of technology transfer from other than track-I site, R&D/QA of receiving unit shall request the responsible person of sending unit for technology transfer documents as mentioned in Annexure – I and same shall be verified by R&D/QA.
6.4.5 After receiving the entire Technology Transfer Documents from sending site, concerned department of receiving site shall prepare documents needed for planning and execution of Technology Transfer in Track – II format.
6.4.6 The responsibility of preparation of documents in Track – II format shall be mentioned in Annexure – II.
6.4.7 Technology Transfer team of Track – I (sending site) shall co-ordinate with technology Transfer Team of Track – II (receiving site) for technical information and planning of Technology Transfer.
6.4.8 In case of technology transfer from other than track-I site, sending unit shall co-ordinate with technology Transfer Team (receiving unit) for technical information and planning of Technology Transfer.
6.5 The Technology Transfer process is divided in different stages as mentioned below:
6.5.1 Preparation of tentative Batch Manufacturing Record & Batch Packing Record
6.5.1.1 R&D/QA/Production department of Receiving Unit shall prepare tentative Batch Production Record (Manufacturing & Packing) based on the Master Formula Record (MFR) of sending site and same shall be approved by QA.
6.5.1.2 After approval of tentative BMR and BPR, QA shall control and issue copies as per the Document Control procedure. (SOP No.: QA002).
6.5.2 Preparation of documents required for Analysis and Testing
6.5.2.1 Quality Control department of receiving site shall prepare the Specification, Standard Test Procedures (STP) and General Test Procedure (GTP) in reference to sending unit
documents and/or BP/EP/USP and based on the Master Formula Record (MFR) of sending site and same shall be approved by QA.
6.5.2.2 QA shall control and issue copies as per the Document Control procedure.
6.5.3 Analytical Method Validation
6.5.3.1 Analytical method transfer shall be carried out as per Analytical Method Transfer Procedure. (SOP No.: QA046)
6.5.3.2 Analytical method transfer protocol will be prepared for transferring of analytical methods from sending unit.
6.5.3.3 Quality Control department shall prepare the Analytical Method Validation protocol based on the analytical methods to be transferred if the method is not validated and the same shall be approved by QA. If the transferred method is a validated one then only verification will be done to demonstrate the suitability. In case the method is not validated either complete validation of the transferred method to be done or analytical method to be developed/written as per the pharmacopoeial and the same shall be validated.
6.5.3.4 After the Analytical Method validation the Quality Control department shall prepare the validation summary report.
6.5.3.5 After successful method validation, QC shall inform through QA to production department for starting Optimization batches.
6.5.4 Process Optimization
6.5.4.1 Based on the Tentative Batch Production Record (Manufacturing & Packing) Validation /QA department shall prepare Optimization Protocol.
6.5.4.2 During the process optimization minimum one batch shall be taken for the optimization as per the tentative Batch Production Record (Manufacturing & Packing) and if required optimization process parameters shall be extended for other batches.
6.5.4.3 Technology Transfer team of BPL Track –II shall execute the process optimization activities in co-ordination with Production, R&D, QA, Validation, QC and Engineering department. If required Technology Transfer team of BPL Track –I shall be present during execution.
6.5.4.4 Any deviation observed during the process optimization shall be documented.
6.5.4.5 If optimization process is found satisfactory, Technology transfer Team shall plan for Process validation of next three consecutive batches.
6.5.5 Process Validation
6.5.5.1 Validation/QA department shall prepare the Validation Protocol based on the tentative Batch Production Record (Manufacturing & Packing) and Process Optimization Report.
6.5.5.2 Process validation shall be executed as per the approved validation protocol.
6.5.5.3 Technology Transfer team of BPL Track –II shall execute the validation activities in co-ordination with Production, R&D, QA, Validation, QC and Engineeringdepartment. If required Technology Transfer team of BPL Track –I shall be present during execution.
6.5.5.4 In case of technology transfer from other than track-I site, technical & analytical experts from sending unit will be invited during optimization and process validation batches manufacturing. It may not be possible for sending site experts to stay till to completion of three process validation batches, only the critical steps of manufacturing /analysis will be performed on their presence and report will be sent to their site for review & approval.
6.5.5.5 Validation / QA department shall compile summary report of three consecutive batches based on the process observations and QC analytical results.
6.5.6 Preparation of Final MFR and BMR / BPR for Commercial Production
6.5.6.1 After successful execution of validation batches R&D/QA shall prepare the final MFR and BMR / BPR for further production and send it to QA for approval, control and issuance as per document control procedure (SOP No.: QA002).
6.6 Artwork Preparation and Approval
6.6.1 SBM/IMT shall prepare the artwork in consultation with QA, R&D and Production and same shall be forwarded to Production, R&D, QA, QC for review and finally approved by QA.
6.7 Clearance for Optimization Batch
6.7.1 Before planning for Optimization batch, Validation /QA department shall review the status of Technology Transfer documents as per checklist attached in Annexure – II.
6.8 Stability Testing
6.8.1 For existing products from Track-I the optimization batch and first validation batches shall be kept on stability studies by the QC department as per the stability plan/protocol. As the product is already in the market, the batch can be released to the local market after 3(three) months of accelerated stability study while the stability will continue as per the plan.
6.8.2 For new product and the products from other than Track-I the optimization and validation batches shall be kept on stability studies by QC department as per the stability study plan/protocol. In this case the batch(s) shall be released after completion of 6(six) months accelerated stability study.
6.9 Summary Report
6.9.1 A summary report of technology transfer shall be prepared by QA department as per Annexure – III.
6.10 The summary report shall be reviewed by QA/ Validation department and finallyshall be approved by the R&D, Production, QC and QA.
6.11 A training program shall be conducted for the shop floor personnel make them to conversant with precautions/ changes during handling of new product and formulation handing over to production for routine use.
