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GLP Series (Schedule L): 11 Internal Quality System Audits

Writer's picture: Marketing - Walter®Marketing - Walter®

In the intricate landscape of laboratory operations, maintaining the highest standards of quality is paramount. Internal quality system audits serve as the linchpin of this commitment, assuring the integrity of analyses and ensuring compliance with both internal protocols and regulatory requirements. Let's delve into the key components that make these audits indispensable for the seamless functioning of our laboratory.

Internal Audit

Key Objectives:

 

1. Rigorous Audits for Unwavering Precision: Internal quality audits are carefully conducted with a predetermined schedule and procedure. Trained and independent personnel rigorously follow a checklist to verify that our operations align with the stringent requirements of our quality system and regulatory authorities. This systematic approach ensures that the integrity of our analyses remains uncompromised, reinforcing our commitment to precision.

 

2. Strategic Periodicity Led by Leadership: The periodicity of these audits is strategically fixed by the Head of the laboratory. Each activity undergoes thorough scrutiny at least once a year, ensuring a comprehensive evaluation of our processes. This strategic approach not only upholds our commitment to quality but also serves as a proactive measure to identify areas for improvement and implement corrective actions promptly.

 

3. Accountability and Corrective Action: The Head of the laboratory takes a central role in initiating corrective actions arising from audits. In the event of non-compliance or diversion from quality policies, the Quality Manager steps in. A detailed analysis is conducted, and necessary actions are taken with meticulous documentation. This dual-layered accountability ensures that our commitment to quality is not only monitored but actively reinforced through corrective measures.

 

4. Comprehensive Record-Keeping for Transparency: The Quality Manager plays a pivotal role in maintaining detailed records of analyses conducted. From the test system used to the date of analysis, this meticulous documentation ensures transparency and accountability. Copies of protocols associated with different activities checked during audits are preserved, creating a comprehensive repository that aids in continuous improvement.

 

Conclusion

 

In conclusion, our commitment to quality is fortified through the rigorous processes of internal quality system audits. As members of this laboratory, let's embrace these audits not only as evaluative measures but as catalysts for continuous improvement. By actively participating in the audit process, we contribute to the precision, compliance, and overall excellence of our laboratory operations.

 

Walter Healthcare exemplifies a commitment to GLP (Good Laboratory Practices) in its pharmaceutical endeavors, ensuring the highest standards of safety, quality, and integrity in the development of life-enhancing medicines.



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