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GLP

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GLP Certification

Good laboratory practice (GLP) is a set of guidelines designed to ensure the quality and integrity of non-clinical laboratory studies used to support research or marketing permissions for items regulated by government agencies.The pharmaceutical business and the mandatory non-clinical animal testing that must be carried out before new drug products are approved are the two things that the word GLP is most frequently linked to. Nonetheless, GLP covers a wide range of other non-pharmaceutical substances, including food additives, medical equipment, food packaging, food contamination limits, and color additives.

What is GLP?

GLP is a quality system for nonclinical health and environmental safety research that includes planning, performance, monitoring, recording, archiving, and reporting processes. Good laboratory practice (GLP) aims to improve the quality and validity of test data used to assess the safety of chemicals, pharmaceuticals, food, and cosmetics. GLP is a quality system that ensures data is consistent, reliable, reproducible, and of high quality and integrity. GLP provides a realistic reflection of test results. Good Laboratory Practices are principles that guide laboratory work planning, performance, monitoring, recording, reporting, and archiving. Good laboratory practice involves planning, reliability, accuracy, recording, reporting, monitoring, and archiving.Good Laboratory Practices are guidelines for planning, performing, monitoring, recording, reporting, and archiving laboratory work. Effective laboratory practice involves planning, recording, reporting, monitoring, and archiving all data generated during analysis or testing.
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WHAT ARE THE BENEFITS OF GLP

GLP certification ensures the validity of each step in the analysis. Assure the quality and integrity of data. submitted to FDA to ensure the safety of regulated items. GLPs prioritize accurate data recording and specimen retention. Benefits of following appropriate laboratory techniques. • Enhance the company's image as a quality producer in the global market. • Offer valuable insights on data analysis, uncertainty measurement, and record-keeping. • Provide detailed testing and measurement guidelines. • Improve rules and controls for instrument maintenance, environmental control, and preservation of test records.

Start your journey to GLP certification

Contact our team today to receive a free no-obligation competitive quotation from our dedicated business development team. We will devise a comprehensive quote that will align with your occupational health and safety requirements. We tailor our quotes to meet your needs, and we support a range of ISO standards, including ISO 27001, ISO 9001 and Cyber Essentials. Learn more about Certification Europe’s accreditations, discover our client testimonials and find out more about working with us.

The Certification Journey

5
Certification Achieved

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

4
Certification Review & Decision

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

3
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.

2
Stage two

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

1
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.