GLP

CMSIL

GLP Certification

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. GLPs were initially invoked in a reaction to malpractices in the laboratories conducting safety experiments of medicines.

What is GLP?

Good Laboratory Practices(GLP) is a quality system concerned with the organizational process and the conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The principle of Good laboratory practice (GLP) : to promote the development of quality and validity of test data used for determining the safety of chemicals, Pharmaceuticals, Food, Cosmetics etc. GLP refers to a quality system to ensure the uniformity, consistency, reliability, reproducibility, quality and integrity of the data. GLP gives true reflection of tested results. Good Laboratory Practices - Good laboratory practices embody a set of principles that provide framework within which laboratory work is planned, performed, monitored, recorded, reported and archived. Good laboratory practice must be planned, reliable, accurate, recorded, reported, monitor and archive all data generated during analysis or testing.
CMSIL

WHAT ARE THE BENEFITS OF GLP

GLP is to certify that every step of the analysis is valid orNot. Assure the quality & integrity ofdata submitted to FDA in support of the safety of regulated products. GLPs have heavy emphasis on data recording, record & specimen retention. Benefits of goodlaboratory practices. • It will give better image of company asa Quality producer in Global market. • Provide hot tips on analysis of data as well as measure uncertainty andperfect record keeping. • Provide guideline for doing testingand measurement indetail. • Provide guidelines and bettercontrol for maintenance of instruments, environment control, preservation of test records etc.

Start your journey to GLP certification

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The Certification Journey

Certification Achieved

Successful certification is communicated to the client. Certificates are issued.

Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made.

Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

Stage two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2

Certification Achieved

Successful certification is communicated to the client. Certificates are issued.

Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made.

Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

Stage two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2

GLP FAQ's

GLP guidelines outline specific requirements for the storage conditions, labeling, segregation, and documentation of laboratory samples and test substances to prevent contamination, degradation, or loss of integrity during storage and analysis.

GLP mandates the validation of analytical methods to ensure their accuracy, precision, specificity, and reliability for generating valid and reproducible test results in compliance with regulatory requirements.

Non-compliance with GLP can lead to data rejection by regulatory authorities, delays in product approval, legal implications, loss of credibility for the laboratory, and potential harm to public health and the environment

GLP emphasizes the humane treatment of laboratory animals, including proper housing, care, and handling, as well as the ethical use of animals in research to minimize pain and distress while obtaining valid scientific results.

Adhering to GLP standards enhances the credibility and acceptance of non-clinical data by regulatory authorities worldwide, facilitating the approval process for new pharmaceuticals, chemicals, and other regulated products.

While GMP focuses on manufacturing processes and GCP on clinical trials, GLP specifically pertains to the conduct of non-clinical safety studies, emphasizing the integrity and validity of data generated in laboratory settings.

GLP ensures the consistency, reliability, and quality of non-clinical safety data generated during research and development by defining standards for conducting and reporting laboratory studies.

GLP stands for Good Laboratory Practice. It is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.

Industries involved in the testing of chemicals, pharmaceuticals, pesticides, cosmetics, and other products that require non-clinical safety assessments are typically required to follow GLP guidelines to ensure the validity and reliability of the data generated.

Compliance with GLP is typically overseen by regulatory authorities such as the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) in Europe. These authorities conduct inspections of testing facilities to ensure adherence to GLP standards.

1.Test Facility Organisation and Personnel. 2. Quality AssuranceProgramme(QAP). 3. Facilities. 4. Apparatus, Material and Reagents. 5. Test systems. 6. Test and Reference Substances. 7. Standard Operating Procedures(SOP). 8. Performanceof The Study. 9. Reporting of Study Results. 10. Storage and Retention of Records and materials.

In the early 70’s FDA became aware of casesof poor laboratory practice all overthe United States. • They discovered a lot fraudulent activities and alot of poor labpractices. • Examples of some of these poor lab practices foundwere 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual labstudy. 3. Inadequate test systems.