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"Good Clinical Laboratory Practice" (GCLP) serves as a recommendation/guideline, offering comprehensive insights into the quality system applicable to organizations and individuals involved in the analysis of samples from clinical trials. This guidance encompasses the necessary facilities, systems, and procedures crucial for ensuring patient safety and maintaining the reliability, quality, and integrity of work and results throughout their contribution to a clinical trial. 

At Global Pharma QA, we are committed to aiding your GCLP Laboratory in achieving and maintaining these guidelines.

Our offerings include GCLP Compliance Certificate: We provide a GCLP Compliance Certificate that is renewable every two years.
 

The Certification process involves:

  1. Gap Analysis:
    For the initial Certification, we recommend a thorough Gap Analysis. This process identifies gaps in GCLP Compliance, offering observations and actionable advice to address and close these gaps effectively.

  2. GCLP Staff Training:
    Comprehensive training for GCLP staff, culminating in a quiz and Training Certification.

  3. 2 or 3 Day Full GCLP Audit (Depends on the site initial compliance level): 
    When your laboratory is ready, we conduct a thorough 2-day GCLP Audit. Following the audit, a detailed report is provided, highlighting observations and finalizing the inspection after reviewing Corrective and Preventive Actions (CAPAs). This process results in the issuance of a GCLP Compliance Certificate, which is valid for two years and can be extended after a reinspection.

 

Trust Global Pharma QA to guide your GCLP Laboratory through this important certification process, ensuring adherence to international standards and best practices in clinical trial sample analysis - The best evidence of your compliance!

Copyright © Orit Galperin. All rights reserved.

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