SOP for Product Transfer to the Manufacturing Site

PURPOSE

To provide a procedure for product transfer of those developed in-house or products being transferred from Pharmainfo Ltd. to other manufacturing sites.

SCOPE

This procedure is applicable for the Transfer of products from Pharmainfo Ltd. (also called as Contract Giver) to other manufacturing sites (also called as Contract Acceptor)

Transfer of products developed in the Formulation Development Department (In-House products) to manufacturing at Pharmainfo Ltd.

RESPONSIBILITY

Production / QA Officer

• Initiate Protocol on Execution of Transfer Batch (PETB), in case of site transfer products.
• Organize CFT meetings and coordinate to complete identified prerequisites before conducting the manufacture of the transfer batch.
• Execute the manufacture of transfer batch(s).
• Evaluate the validation data.
• Coordinate and complete all the identified action points after manufacture of transfer batch(s) and close the protocol for execution of transfer batch.

Production / QA

• Initiate protocol on execution of transfer batch, in case of in-house developed products.
• Execute the manufacture of exhibit batch(s)

Production Head / QA Head

• Participate in the CFT meetings and evaluate the technical and /or documentation support required from the department.
• Ensure that the required support is provided within the agreed upon stipulated timeframe.
• Provide necessary inputs to CFT during the closure of the tech transfer process

Quality Assurance

• Approve the PETB in Phase I and Phase II
• Approve the PETB in Phase I (post-approval), II, and Phase III

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DEFINITIONS

Exhibit Batch (EB): The batch manufactured in the GMP environment for submission to applicable regulatory agencies for demonstrating the procedure and commitments in Master Documents

Confirmation Batch (CB): The batch was manufactured to evaluate the product's feasibility in the PharmaInfo manufacturing environment to build confidence to proceed with process validation.

Optimization Batch: The experience gained from the confirmation batch shall be utilized for suitable amendments in the process, material(s), specifications, etc. as found appropriate before beginning process validation.

Technology Transfer (TT): The transfer of manufacturing technology from PharmaInfo limited manufacturing site to another manufacturing site through process validation.

Transfer Batch: Any batch manufactured as exhibit batch or confirmation or optimization batch or technology transfer batch.

PROCEDURE

Development of in-house Products:

• The development of in-house products shall involve the following elements in brief.

1. Preparation of Product Development Plan
2. Analytical method development and validation
3. Vendor qualification (if applicable)
4. Equipment or change parts procurement (if applicable)
5. Packaging Material Development
6. Laboratory trials, testing and stability studies
7. Scale-up studies, testing and stability studies
8. Finalization of MFR
9. Finalization of finished product specification and testing procedure

Tech Transfer of Customer Products

• The technology transfer of Pharmainfo products to other manufacturing sites shall involve the following elements in brief. Refer to Annexure-1, for the flow chart.

1. Availability of Tech Pack from Pharmainfo /Contract Giver
2. Initiation of Risk Assessment.
3. Initiation of Manufacturing and Test licence.
4. Initiation of procurement process of material required for feasibility trials, confirmation batch, and validation batches.
5. Intimation of changes required (if any) for facilitating the tech transfer.
6. Preparation of draft MFR
7. Execution of feasibility trials (lab scale and /or production scale batch sizes)
8. Finalization of MFR
9. Finalization of finished product specification and testing procedure

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Transfer Process For Exhibition Batch or Confirmation Batch

• Phase I: Initiation of Protocol on Execution of Transfer Batch (PETB)

1. For in-house developed products, Once the following prerequisites are completed, Production shall initiate the PETB (Refer to Annexure-3).
2. PDR
3. MFR
4. Stability Protocol
5. MFR (MPR)
6. Finished Product Specification and Testing Procedure (QC)
7. In the case of TT products, QA shall ensure that the following prerequisites are completed; QA shall initiate the PETB (Refer to Annexure-3).
8. Tech-Pack
9. Training
10. Market Authorization (if applicable)
11. MFR
12. Finished Product Specification and Testing Procedure.

• The PETB shall be numbered as PETB/XX/YY/NN. Where XX is an abbreviation of the initiating department (either Quality Assurance or Production), YY is the year of initiation and NN is the serial number of PETB for the applicable department and year of initiation. Example: The first PETB initiated by Production in the year 2024 shall be numbered as PETB/PR/24/01. The list of PETB shall be maintained by the initiating department.
• QA shall review the completeness of all documents approve the Phase I PETB initiation process and stamp all the pages of approved PETB as ʽʽControlled Documents”.
• The production Head and QA Head of Contract Giver and Contract Acceptor shall organize the CFT meeting involving the following departments:

1. Production
2. Quality Control
3. Quality Assurance
4. Engineering
5. Stores

• The CFT shall discuss and identify the requirements to be completed before the execution of EB/CB.
• The identification shall be evaluated for their status. If the requirements (s) are not available at the time of CFT, the possible date of its completion shall be given by individual CFT members.
• QA ensures that the requirements are completed by the respective departments as stated in the PETB.
• Before the transfer batch, QA shall ensure that all the requirements are met as per PETB.
• QA shall finally evaluate the overall readiness to execute the EB or CB respectively. Any activity that is identified, but not completed shall need further resolution prior to execution of the transfer batch.
• In case of execution of EB/CB without completion of identified requirement, then the same shall be done after giving appropriate justification in the PETB. This shall be referred in the PETB (Phase I closure section of PETB).
• Production / QA shall sign the Phase I closure section of PETB indicating the readiness for conducting the EB/CB.
• QA shall approve the Phase I closure section of PETB indicating approval to execute EB/CB.

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Phase II: Execution of EC/CB and its closure by Contract Acceptor

1. Production/ QA of Contract Acceptor shall execute the manufacturing of EB/CB per the approved MFR.
2. The sampling at various stages of manufacturing EB/CB shall be done as described in the stability protocol and applicable SOPs or protocols.
3. In the case of EB, samples for Bio-Equivalence studies as requested by QC shall be taken, as per their study protocol.
4. The Quality Control Department shall test the samples as per the approved Specifications and Standard Test Procedures and test plan as described in the Stability Protocol/MFR/applicable SOPs of Contract Giver.

• Wherever applicable the validation of analytical methods shall be initiated by QC taken from the EB/CB.
• QA shall review the batch documents and release the batch following the applicable Plant SOPs
• Based on the following documents, the exhibit Batch Summary Report or Confirmation Batch Summary Report shall be compiled by Production and QA respectively.

1. Executed BMR
2. Executed BPR
3. Analytical data of specified samples
4. Analytical data of API and Excipients
5. Analytical data of Packing materials
6. Analytical data of Semi-Finished Goods
7. Temporary Change Controls/Deviations raised (if any) and its resolution.

• Any recommendations to modification in the Master MFR, Master BPR, Specifications or Standard Test Procedures shall be made through the summary report. QA / Production shall initiate the change control for initiating the applicable change as recommended in the summary report.
• Once the EB/CB summary report is approved, Production / QA shall organize the CFT.

1. During CFT, the phase II section of PETB shall be discussed. Once all applicable requirements are completed, the relevant department shall update the same and shall sign the PETB.
2. All the recommendations of the Summary Report shall be ensured for completion during this closure.
3. The Phase II closure of PETB shall be initiated by Production and shall be reviewed and approved by QA
4. The approval of Phase II PETB is indicative that the process of Validation can be initiated by Production.

Phase III: Executive of Technology Transfer (Process Validation) and its closure

• On completion of all activities at the closure of Phase II PETB, Phase III PETB shall be started which includes process validation
• The process validation shall be executed by QA with the support of cross-functional team members as per the approved MFR. The sampling at various stages of validation batches shall be done as described in the validation protocol, Stability Protocol, and applicable SOPs
• The Quality Control Department shall test the samples as per the approved Specifications and Standard Test Procedures and test plan as described in the Stability Protocol/MFR/applicable SOPs.
• QA shall collect the following data for preparation of the Process Validation Report.

1. Executed BMR
2. Executed BPR
3. Analytical data of validation samples
4. Analytical data of API and Excipients
5. Analytical data of Packing materials
6. Analytical data of Semi-Finished Goods
7. Analytical data of Finished Goods
8. Temporary Change Controls/Deviations raised (if any) and its resolution

• The process validation report shall conclude the validation and recommend any changes required in the Master Documents
• All requirements shall be filled in the Phase III portion of PETB and ensure that all the required actions shall be completed and closed.
• Once all the identified requirements are addressed, the same shall be recorded in the PETB. If the change control is raised for the initiation of applicable change, then the reference of change control shall be recorded in the PETB.
• If any item is pending for completion, the same shall be taken up by QA with the applicable department for resolution.
• Upon satisfactory review of all identified requirements, QA shall sign the Phase III closure of PETB to indicate that the technology transfer process has been completed.
• QA shall review the PETB and related documents for completeness and shall sign the PETB to indicate that the transfer process is completed satisfactorily.
• Where applicable the QA shall organize to send the executed documents to Customers/CG.

ABBREVIATIONS

API: Active Pharmaceutical Ingredient

CG: Contract Giver

BMR: Batch Manufacturing Record

CA: Contract Acceptor

BPR: Batch Packing Record

STP: Standard Test Procedure

CFT: Cross-Functional Team

PDR: Product Development Report

MFR: Master Formula Record

PETB: Protocol on Execution of Transfer Batch

MPR: Master Packaging Record

PM: Packing Material

FG: Finished Goods

RM: Raw Material

GMP: Good Manufacturing Practices

QC: Quality Control

ANNEXURES

Annexure-1: Flow chart for the product development process

Annexure-2: Product transfer process.

Annexure-3: Protocol for Execution of Transfer Batch

REVISION HISTORY

Nil

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