Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 1 of 7
Protocol No.: PTP/22xxxx/yy
Product Transfer Protocol
For
(Product Name)
FORM No.: FGSPR/236.00
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 2 of 7
Protocol No.: PTP/22xxxx/yy
PROTOCOL APPROVAL:
The Product Transfer Protocol will be approved for functional specification of HPL and approval
shall be jointly responsible by followings:
Name Designation & Department Sign & Date
Prepared By
Reviewed By
Approved By
Distribution List:
Document History
FORM No.: FGSPR/236.00
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 3 of 7
Protocol No.: PTP/22xxxx/yy
S.
Date Code No. Reason
No.
01 PTP/22xxxx/yy
FORM No.: FGSPR/236.00
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 4 of 7
Protocol No.: PTP/22xxxx/yy
TABLE OF CONTENTS
S. No. Subject Page no.
1 Introduction
2 Objective
3 Scope
4 Responsibility
5 Product details
5.1 General Information
5.2 Formula Related Information
5.3 Reference documents
6 Critical Equipment and Utilities
6.1 List of Utilities
6.2 List of Manufacturing and Packaging Machine
7 Process flow diagram
8 Critical Process Parameters (CPP) and Comparison
9 Critical Quality Attributes (CQA) and Comparison
10 Stability
11 Conclusion
12 Abbreviations
FORM No.: FGSPR/236.00
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 5 of 7
Protocol No.: PTP/22xxxx/yy
1.0 INTRODUCTION
2.0 OBJECTIVE
3.0 SCOPE
4.0 RESPONSIBILITY
Department Responsibility
- To prepare the product specific transfer protocol
- To give training on transfer protocol
- To prepare the product transfer report
Production
- To execute the batches in accordance with GMP using approved
documentation.
- To provide the necessary resources.
Quality Assurance - To review and approve the Product Transfer Protocol.
- To provide the In-process data.
- To collect the sample for evaluation.
Quality Control - To analyze the Finished Product.
Engineering - To provide the utilities, status of calibration & preventive maintenance.
5.0 PRODUCT DETAILS
5.1 General Information
5.2 Comparison of Product Formula
5.4 Batch Size Comparison
5.3 Reference Documents
6.0 CRITICAL EQUIPMENT AND UTILITIES
6.1 List of Utilities
6.2 List of Manufacturing and Packaging Machine
7.0 COMPARISON OF PROCESS FLOW DIAGRAM
Existing New
Steps Steps
Machine Name Machine Name
Control Variables Control Variables
Critical Parameter Critical Parameter
8.0 CRITICAL PROCESS PARAMETERS (CPP) AND COMPARISION:
(Depending upon the nature of product, only use the applicable processes and parameters. If needed,
additional processes and parameters can be included in the table)
Granulation
Existing New
Machine parameter Acceptance Criteria
Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Description, Sealing quality &
Overprinting, Leak test,
Thickness, Hardness,
FORM No.: FGSPR/236.00
Disintegration time, Uniformity
of weight, Dissolution, Assay &
Microbial Analysis
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 6 of 7
Protocol No.: PTP/22xxxx/yy
Compression
Existing New
Machine parameter Acceptance Criteria
Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Coating
Machine parameter Existing New
Acceptance Criteria
(Preheating) Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Machine parameter Existing New
Acceptance Criteria
(Spraying Phase) Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Machine parameter Existing New
Acceptance Criteria
(Drying Phase) Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Machine parameter Existing New
Acceptance Criteria
(Cooling Phase) Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
Blistering
Existing New
Machine parameter Acceptance Criteria
Batch-1 Batch-2 Batch-3 Batch-1 Batch-2 Batch-3
9.0 CRITICAL TESTING PARAMETERS/ CRITICAL QUALITY ATTRIBUTES (CQA)
AND COMPARISION
(Depending upon the nature of product, only use the applicable processes and parameters. If needed,
additional processes and parameters can be included in the table)
No. of Acceptance
Process Parameters Results
Samples Criteria
Existing New
Physical & Chemical Test Batch Batch Batch Batch Batch Batch
Granulation 1 2 3 1 2 3
Existing New
IPC Testing (Physical Test) Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
Compression
Existing New
Release Testing (Physical and Chemical
Batch Batch Batch Batch Batch Batch
test)
1 2 3 1 2 3
FORM No.: FGSPR/236.00
Healthcare Pharmaceuticals Limited.
PROCESS TRANSFER PROTOCOL
Rajendrapur, Gazipur, Bangladesh
Product Name: Page 7 of 7
Protocol No.: PTP/22xxxx/yy
No. of Acceptance
Process Parameters Results
Samples Criteria
Existing New
IPC Testing (Physical Test) Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
Coating
Existing New
Release Testing (Physical and Chemical
Batch Batch Batch Batch Batch Batch
test)
1 2 3 1 2 3
Existing New
IPC Testing (Physical Test) Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
Existing New
Physical Testing (Release Specification) Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
Packaging
Existing New
Chemical Testing (Release Specification) Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
Existing New
Microbial Analysis Batch Batch Batch Batch Batch Batch
1 2 3 1 2 3
10.0 STABILITY
11.0 CONCLUSION
12.0 ABBREVIATIONS
FORM No.: FGSPR/236.00