Independent GCLP assessment of your laboratory’s quality systems and clinical trial sample analysis activities.
Global Pharma QA Ltd offers Good Clinical Laboratory Practice (GCLP) compliance assessment and certification for laboratories analysing samples from clinical trials.
The assessment considers the facilities, personnel, procedures, systems and records supporting the quality, reliability and integrity of laboratory work.
The applicable guidance and assessment scope are agreed before the audit, and based on the the European Medicines Agency’s (EMA) Reflection paper on laboratory analysis of clinical trial samples.
At Global Pharma QA Ltd., we are committed to aiding your GCLP Laboratory in achieving and maintaining compliance.
Our offerings include GCLP Compliance Certificate, renewable every two years.
The Certification process involves:
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Optional 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. This step would be shorter for high compliance laboratories. -
Optional GCLP Staff Training:
Comprehensive training for GCLP staff, culminating in a quiz and providing individual/group Training Certificate. -
2 or 3 Day Full GCLP Audit (Depends on the site initial compliance level):
When your laboratory is ready, we conduct a thorough 2 to 3 day GCLP Audit. Following the audit, an observations report is provided, and finalizing the inspection is after reviewing your 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 GCLP compliance!
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