Standard Operating Procedure (SOP) for Process Validation

Cleaning of High Performance Liquid Chromatography (HPLC)

1. Purpose

The purpose of this Standard Operating Procedure (SOP) Process Validation is to outline the procedures and guidelines for the validation of manufacturing processes within [Company Name]. This SOP Process Validation aims to ensure that processes consistently produce products that meet quality, safety, and regulatory requirements.

2. Scope

This SOP for Process Validation applies to all manufacturing processes within [Company Name], including new processes, modified processes, and existing processes that require revalidation. It encompasses the planning, execution, and documentation of process validation activities.

3. Definitions

3.1 Process Validation:

The documented evidence that a manufacturing process is capable of consistently producing products meeting predetermined specifications and quality attributes.

3.2 Qualification:

The documented process of demonstrating that equipment or systems are properly installed, function correctly, and perform within specified limits.

3.3 Protocol:

A detailed written plan specifying the steps to be taken, materials to be used, and acceptance criteria to be met during process validation.

4. Process Validation Planning

5. Process Identification

5.1 The Quality Control department, in collaboration with relevant stakeholders, shall identify processes requiring validation based on risk assessment, regulatory requirements, and criticality to product quality.

5.2 New processes and significant process changes shall be prioritized for validation.

6. Protocol Development

6.1 For each identified process, a validation protocol shall be developed, outlining the objectives, scope, acceptance criteria, testing methods, and validation approach.

6.2 The protocol shall be reviewed and approved by relevant departments before validation activities commence.

7. Process Qualification

8. Installation Qualification (IQ)

8.1 The Equipment Maintenance team shall ensure that equipment or systems to be used in the validated process are properly installed, calibrated, and meet required specifications.

8.2 The installation qualification shall be documented and approved before proceeding to the next validation phase.

9. Operational Qualification (OQ)

9.1 The process shall be operated under normal conditions, and critical parameters shall be tested to verify consistent and reliable performance.

9.2 The operational qualification shall be documented, and results shall meet predefined acceptance criteria.

10. Performance Qualification (PQ)

10.1 The process shall be subjected to a series of tests to demonstrate that it consistently produces products meeting specified quality attributes.

10.2 The performance qualification shall be conducted under actual production conditions and extensively documented.

11. Validation Completion and Reporting

12. Data Analysis and Reporting

12.1 The collected data from the validation activities, including IQ, OQ, and PQ, shall be analyzed to ensure compliance with acceptance criteria and product specifications.

12.2 A validation report shall be prepared, summarizing the results, conclusions, and any deviations encountered during the process validation.

13. Approval and Documentation

13.1 The validation report shall be reviewed and approved by relevant departments, including Quality Assurance and Regulatory Affairs.

13.2 The approved validation report shall be appropriately documented and maintained for future reference and regulatory compliance.

14. Process Revalidation and Change Control

15. Revalidation

15.1 Processes shall undergo periodic revalidation according to a predetermined schedule or when significant changes occur.

15.2 Revalidation shall follow similar protocols and procedures as initial process validation.

16. Change Control

16.1 Any changes to the validated process, equipment, or critical parameters shall be assessed for their impact on product quality and may require revalidation.

16.2 Change control procedures shall be followed, including assessing the need for revalidation and obtaining necessary approvals.

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