TEM-300: PRODUCT TRANSFER PROTOCOL

[Insert name of product/s covered by the protocol]

WRITTEN: CHECKED:

Signature:

Position:

Date:

AUTHORISED TO PROCEED:
Insert name of transferring site Insert name of receiving site
Quality Quality
Manufacturing Manufacturing
Assurance Assurance
Signature:

Position:

Date:

PROTOCOL COMPLETE
Insert name of transferring site Insert name of receiving site
Quality Quality
Manufacturing Manufacturing
Assurance Assurance
Signature:

Position:

Date:

Transfer Protocol Objective

The objective of this protocol is to provide an overview, strategy and documented evidence of the
activities carried out in support of the transfer of insert product name/s from insert transferring
site name to insert receiving site name.

The details collated within this guidance document will also support the necessary information required to
submit the change of site information to local and Overseas Regulatory Authorities.

Any changes to materials, processes or testing procedures should be evaluated and approved.

Insert pictures of the products being transferred. Include photographs of the various packaging formats.

General Information
Complete table as required.
ITEM CURRENT PRODUCT TRANSFERRED PRODUCT

Company

Site Of Manufacture
Bulk Description
and Batch Size
Finished Goods
Descriptions and
Sizes
Reason for Transfer

Documentation Transfer
Transfer a copy of all product documentation from transferring facility to receiving facility. Record all
documents codes, versions and descriptions in Appendix 1.

Technical Documents to be transferred should include the following:

 Formulation sheets
 Manufacturing Instructions
 Packaging Instructions
 Product specifications and Test Methods
 Raw Material Specifications and Test Methods
 Packaging Component Specifications
 Relevant Standard Operating Procedures

Tick the appropriate box to identify the responsible party

RESPONSIBILITY
 Transferring Receiving
Facility Facility

Transfer of Technical Documents 

Transcribing Documents into new site format 

Note: it is imperative that all documents transferred are listed and verified to ensure that we
maintain a legal record of what has been sent.

Process / Equipment Description

Attach a process comparison for the current and proposed manufacturing and packaging processes and
highlight any differences, including critical parameters where special attention may be required for bulk
manufacture or packaging. Also include in this comparison, the registered details for the product (where
available). Refer to Appendix 2.

Attach an equipment comparison for the current and proposed manufacturing and packaging equipment
and highlight any differences. Refer to Appendix 2.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving
Facility Facility

Current vs Proposed Manufacturing

Current vs Proposed Packaging

Current vs Proposed Equipment

Product Formulation & Batch Size

Attach a copy of the current and proposed product formulations and batch size details. Individual
ingredient concentrations should remain unchanged irrespective of changes to the batch size. The
formulation information should detail actual ingredient quantity including % concentration information.
Refer to Appendix 3.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY
 Transferring Receiving Facility
Facility

Current & Proposed Formulation attached

Materials / Components Suppliers & Manufacturers

This section should identify any planned changes to packaging or raw materials.

Complete a comparison of current versus proposed packaging components including manufacturer

details. Reference any change controls as necessary. Refer to Appendix 4.

Complete a comparison of current raw materials versus proposed materials. This will also include
identifying differences in specifications and manufacturers. Reference any change controls and material
evaluations as necessary. Refer to Appendix 5.

Include copies of raw material origin (BSE / TSE statements) in Appendix 6.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Current & Proposed Starting materials

Raw material comparison and evaluations

Raw Material Origin

Analytical Method Transfer

This section should outline the method validation and transfer strategies to be applied.

The analytical methods used for starting materials originate from standard insert relevant compendia and
codex references (BP, USP, FCC etc). The receiving site will use these standard monographs to assess
the suitability of individual starting materials. In some instances starting materials may contain specific in-
house tests designed to add value to the product and should remain unchanged.

Given the simplicity of the starting material testing methods and their general monograph origin, it is not
considered necessary to perform analytical method transfer for the starting materials.

It is a corporate requirement that an Analytical Method Transfer be completed between the transferring
and the receiving laboratories according to the guidelines set out in [enter guide name]. Also specify any
additional regulatory requirements that must be satisfied.
NOTE: If any of the analytical methods are not validated, then a validation strategy for these methods
should be outlined in this section.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Method Validation

AMTE protocol preparation

AMTE testing

Comparative Dissolution

Comparative Bulk Product Testing

Validation Strategy
This section should outline the trial and validation strategies to be applied to process, packaging,
equipment, utilities, facility and computers.

A total of insert # of process or packaging batches will be manufactured at the Receiving Facility. Testing
will be as specified in the Validation Protocol in accordance with receiving site Quality Standards and
approved by the appropriate authorities.

IQ, OQ and PQ will be performed on insert the equipment, facility, utility, or computer names. Testing will
be as specified in the Validation Protocol in accordance with Site Quality Standards and approved by the
appropriate authorities.

Copies of the approved protocols and reports should be attached to Appendix 8.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Process Validation (documentation and

execution)

Packaging Validation (documentation and

execution)

Equipment Validation (documentation and

execution)
 Computer Validation (documentation and
execution)

Facility / Utility Validation (documentation and

execution)

Cleaning Assessment
It is a corporate requirement that Cleaning Validation be performed on all product contact equipment
according to the guidelines set out in PQS V7105. An assessment of the products under transfer should
be made against the site Cleaning Validation Plan to determine if the products alter the existing validation
strategy. A copy of this assessment should be included in Appendix 9.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Cleaning Assessment

Stability
The first three validation batches of each product shall be placed on stability. Stability will be performed in
accordance with regulatory requirements for the appropriate markets. Copies of the approved protocols
should be attached to Appendix 10.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Stability Requirements

Batch Manufacturing Order

Attach an uncontrolled copy of the Batch Instructions used to manufacture each of the validation batches
to Appendix 11.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY
 Transferring Receiving Facility
Facility

Batch Records ✔

Certificates of Analysis (C of A)
Include C of A’s for each of the validation batches. Refer to Appendix 12.

Tick the appropriate box to identify the responsible party

RESPONSIBILITY

Transferring Receiving Facility

Facility

Validation report and Certificates of Analysis ✔

Appendices

Appendix Number Appendix Description Number of Pages

Appendix 1 Documentation Transfer

Process / Equipment Description and Critical

Appendix 2
Parameters

Appendix 3 Product Formulation and Batch Sizes

Appendix 4 Packaging Components

Appendix 5 Raw Material Comparison

Appendix 6 Raw Material Origin

Appendix 7 Analytical Method Transfer

Appendix 8
Validation Strategy
Appendix 9 Cleaning Cycle Assessment

Appendix 10 Stability

Appendix 11 Batch Manufacturing Order

Appendix 12 Certificate of Analysis

Appendix 1

Documentation Transfer

(Attachment)

Documentation Transfer List

Insert details of ALL Technical Documents transferred.

Provided Received
Document Version By By
Description
Number Number Initial & Initial &
date date
 Appendix 2

Process / Equipment Description and Critical

Parameters

Process Description for insert name of product Tablets

Insert details of each major step in the manufacturing and packaging processes

REGISTERED
CURRENT PROPOSED
PROCESS (IF DIFFERENCES
PROCESS PROCESS
APPLICABLE)

Critical Parameters for insert name of product

Insert details of any critical process parameters

 PARAMETER CURRENT PROCESS REFERENCE PRO

Equipment Overview

Insert details of all manufacturing and packaging equipment

PROPOSED
PROCESS CURRENT EQUIPMENT DIFFERENCES
EQUIPMENT

Appendix 3

Product Formulation and Batch Sizes

Attach a copy of the current and proposed formulation details

 Appendix 4

Packaging Components

PACKAGING COMPONENTS

Insert name of components.

Complete table with details of all components. Repeat for each component under transfer.

ITEM Current Product Transferred Product

Item
Description
Specification #
Supplier
Manufacturer

Item
Description
Specification #
Supplier
Manufacturer

Item
Description
Specification #
Supplier
 ITEM Current Product Transferred Product

Manufacturer

Item
Description
Specification #
Supplier
Manufacturer

Appendix 5

Raw Material Comparison

MANUFACTURING BILL OF MATERIALS

Complete table with details of all raw materials.

ITEM Current Product Transferred Product

Material Description
Material ID #
Specification
Reference
Supplier
Manufacturer
Standard Quantity per
Batch

Material Description
Material ID #
Specification
Reference
Supplier
Manufacturer
Standard Quantity per
Batch
ITEM Current Product Transferred Product

Material Description
Material ID #
Specification
Reference
Supplier
Manufacturer
Standard Quantity per
Batch

Material Description
Material ID #
Specification
Reference
Supplier
Manufacturer
Standard Quantity per
Batch

Appendix 6

Raw Material Origin

Attach BSE / TSE certificates

Appendix 7

Analytical Method Transfer

Attach Method transfer and Validation Reports as required.

Appendix 8

Validation Strategy

Attach Trial and Validation Protocols and Reports as required.

Appendix 9

Cleaning Cycle Assessment

Attach Cleaning Assessment Reports as required.

Appendix 10

Stability
 Attach Stability Protocols as required.

Appendix 11

Batch Manufacturing Records

Attach copies of the completed manufacturing and packaging batch records from
each validation batch

Appendix 12

Certificate of Analysis
Attach copies of the C of A’s from each validation batch