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GLP

Good Laboratory Practice

Standard brief

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, GLP applies to many other non-pharmaceutical agents such as colour additives, food additives, food contamination limits, food packaging, and medical devices.

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Benefits

Primary Benefit of GLP

The primary benefit of following current Good Laboratory Practice is the creation of a document trail providing traceability for all measurements. This leads to the creation of technically defendable scientific data, by which its quality, reliability and trustworthiness can be assured.

Other Benefits of GLP

This in turn will lead to many other benefits for both the laboratory and its customers, including:

  • Increased confidence in the reliability and trustworthiness of laboratory data

  • Increased production of right first time results

  • Increased overall productivity

  • Increased laboratory reputation

  • Reduced need for re-work

  • Reduced time spent on non-revenue earning investigations

Concepts

  • Organization and Personnel – Responsibilities – Management, Sponsor, Study Director, Principal Investigator & Study Personnel
  • Quality assurance program – Quality Assurance Personnel
  • Facilities – Test System Facilities & Facilities for Test and Reference Items
  • Equipment, reagents and Materials
  • Test systems – Physical, Chemical & Biological
  • Test & Reference items
  • Standard operating procedures
  • Performance of Study – Study Plan & Conduct of Study
  • Reporting of results
  • Archival – Storage of Records and Reports

International Compliance

GDPR

General Data Protection Regulation for personal data. Learn More

HIPAA

Health Insurance Portability and Accountability Act. Learn More

HACCP

Hazard Analysis and Critical Control Points for food safety. Learn More

FSSC 22000

Food Safety System Certification for food safety and quality. Learn More

Global G.A.P.

Good Agricultural Practices for quality agricultural produce. Learn More

GDP

Good Distribution Practice for pharma and food sectors. Learn More

GMP

Good Manufacturing Practice for manufacturing sectors. Learn More

GLP

Good Laboratory Practice for systematic laboratory operations. Learn More

RoHS

Restriction of Hazardous Substances for products in EU. Learn More

HALAL

Food safety practices and systems as per Shariah, Islamic Law. Learn More

KOSHER

Food safety practices as per standards of Kashrut, Jewish Law. Learn More

Let's Work Together

European Assessment and Certification Ltd.
19, Layton Crescent, Slough, SL38DP, UK.
Company Number 12819256

+44 7459 282344
[email protected]