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Auditing Services

Good Laboratory Practice (GLP) / Good Clinical Laboratory Practices (GCLP)

What is a Good Laboratory Practice (GLP) audit?

Good Laboratory Practice (GLP) audits are a required step in obtaining premarket approval of regulated products. GLP is a quality system that ensures the quality and credibility of research results. It involves the planning, performance, monitoring, recording, archiving, and reporting of non-clinical health and environmental safety studies.

GLP audits can be remote or onsite. QA professionals monitor GLP compliance by conducting audits of facilities, ongoing work, and various documents

Purpose of GLP Auditing

The main goal of GLP regulations is to ensure compliance in the conducting of nonclinical laboratory studies. These studies investigate certain test articles and test substances.

  • Test article – is any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation.
  • Test substance – is any substance or mixture that is administered or added to a test system in a study.

Conducting GLP audits is a required step in obtaining premarket approval of regulated products.

Non-Clinical (GLP) Auditing

  • Laboratories
  • Internal GLP Study
  • Internal GLP Facility
  • External GLP Study
  • External GLP Facility
    • Developmental & Reproductive Toxicology Study
  • Neurobehavior Study (Animal Model)
  • Toxicology Study (Animal Model)
    • Vivarium / Animal Husbandry
  • Bioanalysis Testing
    • Method Validation
    • Sample Analysis
    • Pharmacokinetics / Pharmacodynamics (PK/PD) Studies
    • Anti-Drug Antibody (ADA) Testing
    • Flow Cytometry Testing
    • qPCR Testing
    • Biomarker Testing
    • Immunology Testing
    • Immunohistochemistry Testing
    • Pathology / Histopathology Testing
  • QMS System
  • Archives
  • Gap Analysis
  • QMS Projects
  • Inspection Readiness and Mock Inspection

Importance of GLP Auditing

In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.

Auditing Services

Good Clinical Laboratory Practices (GCLP)

What is a Good Clinical Laboratory Practices (GCLP) Audit?

Good Clinical Laboratory Practice (GCLP) guidelines describe the application of those Good Laboratory Practice principles that are relevant to the analyses of samples from clinical trials while ensuring the purpose and objectives of the Good Clinical Practice principles are maintained.

Purpose of Good Clinical Laboratory Practices (GCLP)

The main objective of developing a quality system using GCLP standards was to provide research data that are of high quality and reliable while also achieving GCLP accreditation. GCLP was chosen as the best platform to achieve this because samples used for this research were being received from clinical trials.

Clinical GCLP Auditing

  • Bioanalysis Testing
  • Flow Cytometry Testing
  • qPCR Testing
  • Vendor Audits
  • Equipment / System Validation
  • QMS System
  • Archives
  • Gap Analysis
  • QMS Projects
  • Inspection Readiness and Mock Inspection

Importance of GCLP Auditing

Laboratories are a fundamental source of scientific evidence critical for clinical research and decision-making in clinical diagnostics and patient care. Because of this, laboratories must meet quality and management standards so that the results they produce are unbiased, accurate, and complete. GCLP provides a bridge between GCP and GLP audits and regulations.

GCLP compliance auditing allows for:

  • Laboratory results (research or diagnostic) that are reliable, reproducible and auditable.
  • The incidences of false negatives and false positives are reduced.
  • Results are assured to be of the highest quality.
  • Results are comparable to those obtained in other compliant laboratories around the world.
  • Building the confidence of staff, sponsors, and clients
  • Resources are efficiently managed therefore minimizing waste.
  • Uniformity and standardization of systems