Qualification Protocols and Deviations

How to Perform Impact Assessment for Equipment Deviations

How to Perform Impact Assessment for Equipment Deviations How to Perform Impact Assessment for Equipment Deviations The pharmaceutical industry operates under strict regulatory standards that dictate stringent requirements for validation processes. Ensuring that equipment used in manufacturing is properly qualified…

Acceptance Criteria for Repeating Failed OQ or PQ Tests

Acceptance Criteria for Repeating Failed OQ or PQ Tests Acceptance Criteria for Repeating Failed OQ or PQ Tests In the context of computer system validation in pharma, the execution of Operational Qualification (OQ) and Performance Qualification (PQ) protocols is critical…

Deviation Trending in Equipment Qualification Reports

Deviation Trending in Equipment Qualification Reports Deviation Trending in Equipment Qualification Reports The process of equipment qualification is a critical component of the pharmaceutical validation lifecycle that ensures systems and processes are designed, implemented, and operated correctly to produce consistent…

Writing CAPA for Failed Equipment Qualification Activities

Writing CAPA for Failed Equipment Qualification Activities Writing CAPA for Failed Equipment Qualification Activities In the highly regulated pharmaceutical industry, compliance with regulatory requirements necessitates robust validation processes. Among these processes, computer system validation (CSV) is a critical aspect that…

Template for Tracking Qualification Deviations

Template for Tracking Qualification Deviations Template for Tracking Qualification Deviations This article provides a comprehensive step-by-step tutorial on the qualification lifecycle, emphasizing the critical role of computer validation in the pharmaceutical industry. Each step aligns with the established guidelines from…

Justifying Retesting After a Protocol Deviation

Justifying Retesting After a Protocol Deviation Justifying Retesting After a Protocol Deviation In the highly regulated pharmaceutical industry, strict adherence to validation protocols is essential to ensure product quality and compliance with regulatory standards. One critical aspect of validation is…

Handling Minor vs Major Deviations in Qualification

Handling Minor vs Major Deviations in Qualification Handling Minor vs Major Deviations in Qualification The qualification and validation processes are crucial for ensuring that any computer systems utilized in the pharmaceutical industry operate within defined limits and functions effectively. In…

Who Approves Deviations in Equipment Qualification Protocols

Who Approves Deviations in Equipment Qualification Protocols Who Approves Deviations in Equipment Qualification Protocols In the pharmaceutical industry, ensuring the compliance and integrity of computer systems is essential for maintaining product quality and patient safety. This comprehensive guide outlines the…

Change Control During Qualification Execution: Guidelines

Change Control During Qualification Execution: Guidelines Change Control During Qualification Execution: Guidelines Effective change control is an essential component of computer system validation in the pharmaceutical industry. It ensures that any modifications made during qualification and validation processes do not…

Qualification Deviations That Lead to Audit Findings

Qualification Deviations That Lead to Audit Findings Qualification Deviations That Lead to Audit Findings Effective qualification and validation of pharmaceutical processes and systems are critical to comply with regulatory requirements and ensure product quality. However, deviations during qualification can lead…