In this article, we will discuss the validation summary report for a computerized system in the pharmaceutical industry. The following section explains 10 components of VSR along with examples and statements.
What a Validation Summary Report?
Let’s understand what a validation summary report is. It’s a report where you capture all the details of performed validation activities, such as the deliverables you prepared, IQ/PQ satisfactorily performed, and if any discrepancies are observed, then the details of the discrepancy along with the resolution. Such details need to be defined in the validation summary report. The validation summary report provides an overview of the entire validation project. It also ensures that the system is qualified in compliance with all applicable regulatory requirements and procedures.
Related: Responsibilities of the Validation Team to Meet the cGMP Compliance
A Practical Approach to writing a Validation Summary Report:
Below are the 10 components of a Validation Summary Report in Pharmaceuticals:
1. Purpose:
Now, Next, we will discuss the practical approach to writing a validation summary report. The first component of the validation summary report is the purpose section, which defines the objectives of the validation approach. In this section, we need to define the objectives, such as summarizing the activities and deliverables identified in the validation protocol to validate the system.
2. Validation Overview:
The second component is the validation overview section. Here, we need to describe the detailed overview of the system, such as change control details (change control number, initiation, and approval date) and validation protocol details (protocol number and execution status). We also need to define the conclusion statement, stating that the system was successfully validated and released for routine use in the production environment. we also need to define that the system was correctly installed and validated, ensuring that the hardware and software are accurately installed according to installation requirements and can consistently produce results meeting predefined acceptance criteria, demonstrating suitability for the intended use.
Related: 4 Types of Process Validation in Pharmaceutical and Protocol
3. Testing summary:
The third component of the validation summary report is the testing summary. Here, we need to define the IQ testing summary, including the start and completion dates of installation qualification, IQ acceptance criteria, IQ status, and any discrepancies observed. Similarly, we need to define the OQ testing summary and PQ testing summary, including start and completion dates, acceptance criteria, status, and discrepancies observed.
Example:
| Sr. No. | Testing Protocol No. | Test ID | Status | Discrepancy | Remark |
|---|---|---|---|---|---|
4. Discrepancy and Closure Status:
The fourth component is the discrepancy and closure status. Here, we need to define all discrepancy details observed during the validation activities, including test ID, test step details, discrepancy number, details of the discrepancy, resolution, and closure status.
5. Supporting Documents:
The fifth component is the supporting documents section, where we define the supporting documents prepared for the validation activities, such as vendor audit reports and training records.
6. Existing System Retirement:
The sixth component is the existing system retirement section, describing change control details for the retirement of an existing system if applicable.
7. System inventory:
The seventh component is the system inventory, describing if the system has been added or removed from the inventory list.
8. Summary of Validation Deliverables:
The eighth component is the summary of validation deliverables, mentioning all deliverable names, document numbers, and approval dates.
9. Conclusion and intended use statement
The ninth component is the conclusion and intended use statement, stating that all qualification activities were performed as per the approved validation protocol and met all acceptance criteria of the validation approach.
10. System release and intended use statement
The tenth component is the system release and intended use statement, certifying that after approval of the report, the system can be used routinely for its intended purpose and has been successfully validated as per approved validation protocol, regulatory requirements, and in-house procedures.
Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at [email protected].
