Regulatory Context

The regulatory landscape for clinical trials is constantly evolving, with increasing requirements to ensure patient safety and data integrity.

The International Council for Harmonisation (ICH) developed the Good Clinical Practice (GCP) guidelines, which define key requirements, including the roles of the Ethics Committee, sponsor, and investigator. However, it provides limited guidance on the standards for analysing samples from clinical trials.

Since sample analysis is a critical component of the clinical trial process, generating important data across various endpoints, it must be conducted to rigorous standards. Ensuring proper collection, analysis, and reporting is essential to protect patient safety and guarantee that the data produced is reliable, accurate, and compliant with GCP regulations.

What is GCLP?

Good Clinical Laboratory Practice (GCLP) provides a unified framework for laboratories analysing clinical trial samples. It establishes clear guidelines on facilities, systems, and procedures, ensuring compliance with international regulatory expectations. This standard promotes global acceptance of clinical data by regulatory authorities.

GCLP Guidelines

Originally produced in 2002 and updated in 2012, the GCLP guidelines define quality systems for laboratories handling clinical trial samples. These guidelines have been widely adopted by organisations such as:

• World Health Organization (WHO),
• Pharmaceutical companies,
• Research institutions & Non-Governmental Organisations (NGOs),
• Hospitals & Contract Research Organisations (CROs),
• Academic institutions.

GCLP is recommended for any organisation analysing human samples from clinical trials, whether for safety screening, pharmacokinetics, electrocardiogram analysis, or any other clinical trial sample requiring evaluation.

GCLP Accreditation Scheme

The GCLP Accreditation Scheme allows laboratories to demonstrate compliance with international standards, ensuring:

• Reliability, quality and integrity of data,
• Regulatory acceptance by global agencies,
• Protection of patient rights and confidentiality.

Since 2003, over 100 laboratories worldwide (UK, Europe, Africa, Asia, and the USA) have joined the scheme. Participants include:

• Hospital Laboratories,
• Central Laboratories,
• Company Laboratories,
• Research Laboratories,
• Investigator Site Laboratories.

‘Regardless of the laboratory’s specific work, it can join the GCLP accreditation scheme as long as it analyses human samples from clinical trials.’

Accreditation Process

1. Application received from new laboratory or confirmation received from an existing member of the scheme to initiate their follow up surveillance audit. Same process is followed hereafter.
2. Audit date is scheduled & auditor(s) is/are appointed.
3. Opening meeting: The auditor(s) explain(s) the purpose and scope of the audit.
4. Audit Process: review of documentation, ongoing work, Laboratory facilities. Potential laboratory personnel interviews.
5. Close out meeting: Auditor(s) present audit findings & indicate the recommended category of accreditation.
6. Report sent to Laboratory within 20 working days.
7. Response from the Laboratory in writing within 30 working days of the date on the report. Actions taken or planned, including timelines, to be notified to action owner.
8. Accreditation Certificate Issued
   Category:
   Full accreditation: No significant non-compliances raised (i.e. no critical or major non-compliance).
   Conditional accreditation: Numerous significant major non-compliances raised (Category remains until follow up surveillance audit).
   If accreditation is not granted based on the responses received from the Laboratory, the Laboratory must address all the issues of concern before re-applying for accreditation.

All steps of the accreditation process are operated by Pharmalys Ltd.

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