GOOD LABORATORY PRACTICE
Good Laboratory Practice (GLP) is a set of principles that govern the planning, execution, monitoring, documentation, reporting, and archiving of laboratory studies. GLP is critical to assuring the traceability and credibility of provided data and successfully resolving the issue of non-reproducibility in pharmaceutical analysis. Moreover, it minimizes adverse drug effects and enhances human health and environmental safety profiles. Transparent and detailed documentation under GLP enhances accountability and precision by assigning responsibility at each step of the experiment. Notably, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) recognizes GLP as a prerequisite for the successful international registration of pharmaceuticals. GLP certification benefits organizations by enhancing data reliability, improving regulatory compliance, and bolstering their reputation. It streamlines the approval process, reduces time-to-market, and mitigates risks associated with non-compliance. Furthermore, GLP fosters collaboration, boosts scientific credibility, and ensures data integrity, ultimately contributing to better decision-making and increasing human health and environmental safety.
CERTIFICATION AND AUDITING SERVICES BY CERTPRO FOR GLP
At CertPro, we understand the significance of adhering to Good Laboratory Practice (GLP) guidelines and the benefits of obtaining GLP certification for organizations seeking to enhance their laboratory processes. We offer comprehensive assistance to organizations pursuing GLP certification. Our team of experts will guide you through the certification process, ensuring that your laboratory practices align with the latest GLP standards. We will collaborate closely with your team to develop and implement a tailored GLP compliance framework that addresses your specific needs and regulatory requirements in the industry.
WHY CHOOSE CERTPRO FOR GLP CERTIFICATION AND AUDITING?
CertPro is a reliable and trustworthy partner for Good Laboratory Practice (GLP) certification and auditing services. With our extensive experience spanning nearly a decade, we possess in-depth knowledge of the complexities associated with laboratory management. Here are several compelling reasons why CertPro is the perfect solution for your GLP certification needs:
|Time to Certification||4x faster than traditional approaches|
|Price||Competitive rates with flexible options|
|Process||Streamlined and efficient methodology|
|Expertise||10+ years of industry experience|
CERTPRO’S COST-EFFECTIVE APPROACH TO GLP CERTIFICATION
When it comes to Good Laboratory Practice (GLP) certification, the overall cost is a crucial factor to consider, as it encompasses various elements that impact expenses. At CertPro, we recognize the significance of cost-effectiveness and aim to deliver customized and affordable solutions to fulfill your organization’s GLP requirements. Here’s a summary of our cost-effective approach to GLP certification:
|No. of employees||Timeline||Cost (approx.)|
|1 – 25||4 weeks||2500 USD|
|25-100||6 weeks||3500 USD|
|100-250||6-8 weeks||5000 USD|
|250 plus||8 weeks||Custom plans|
UNDERSTANDING THE GOOD LABORATORY PRACTICE
GLP is a set of principles and quality standards that guide the planning, execution, monitoring, recording, reporting, and archiving of laboratory studies. It aims to ensure the credibility, traceability, and reliability of data submitted in various fields, particularly in the pharmaceutical industry and other regulated sectors. GLP is not a scientific management system but a quality management system that assures study conduct, data collection, and results reporting. It focuses on maintaining the highest standards of study integrity, data management, and documentation.
One of the primary objectives of GLP is to address the issue of non-reproducibility in biopharmaceutical experiments. By following GLP guidelines provided by the OECD, laboratories can establish transparent and detailed documentation of their work, ensuring accountability and precision. GLP emphasizes the importance of adherence to protocols and the assignment of responsibility at various steps in the experiment. This approach helps improve the quality, integrity, and reliability of studies, as well as the traceability of data.
Within the framework of GLP, establishing a Quality Assurance unit (QA) is a crucial component. The QA unit assumes the role of an independent body responsible for monitoring the entire study process, including conduct, analysis, and reporting. It verifies adherence to written procedures and ensures that necessary reviews and approvals follow the organization’s Standard Operating Procedures (SOPs). Through QA audits, confidence is gained in the proper execution of procedures, although they do not guarantee scientific quality or the absence of errors in the analysis.
KEY PRINCIPLE OF GOOD LABORATORY PRACTICE
GLP principles encompass the integrity, traceability, and quality of data in laboratory studies, containing the following key aspects:
- Organization and Personnel
- Management Responsibilities: Clearly defined roles and responsibilities for management personnel overseeing GLP studies
- Sponsor Responsibilities: The Sponsor of the study holds responsibility for the GLP compliance of the study.
- Study Director Responsibilities: The study director is accountable for the overall conduct and integrity of the study.
- Principal Investigator Responsibilities: The principal investigator oversees the scientific aspects of the study.
- Study Personnel Responsibilities: All personnel involved in the study must have defined responsibilities and appropriate training.
- Quality Assurance Program
- Quality Assurance Personnel: Dedicated personnel responsible for implementing and maintaining the quality assurance program, conducting audits, and ensuring compliance with GLP standards
- Test System Facilities: Adequate facilities, including appropriate housing, feeding, and care, for the test system (e.g., laboratory animals) used in the study
- Facilities for Test and Reference Items: Proper storage and handling facilities for the test and reference items used in the study
- Equipment, Reagents, and Materials
- Ensure that the laboratory equipment, reagents, and materials used in the study are suitable, calibrated, and maintained as per GLP requirements.
- Test Systems
- Physical or Chemical: Guidelines that govern the selection, handling, and characterization of physical or chemical test systems utilized in the study
- Biological: Guidelines for the Selection, Handling, and Housing of Biological Test Systems, such as Laboratory Animals
- Test and Reference Items
- Guidelines regarding the handling, characterization, storage, and documentation of the test and reference items employed in the study
- Standard Operating Procedures
- Detailed procedures and protocols that define how specific tasks should be performed during the study ensure consistency and reliability.
- Performance of Study
- Study Plan: These principles require a comprehensive plan that contains the study’s objectives, methodology, and schedule for development.
- Conduct of Study: Adherence to the study plan, proper data collection, documentation, and record-keeping throughout the study
- Reporting of Results
- Clear and accurate reporting of study results, including the presentation of data, statistical analysis, and interpretation of findings.
- Archival: Records and Report Storage
- Proper storage and retention of all study-related records and reports is required to ensure accessibility and traceability for future reference and regulatory purposes.
These principles collectively provide a framework for maintaining quality, integrity, and consistency in laboratory studies conducted under GLP guidelines. Compliance with these principles ensures that studies are well-documented, reliable, and reproducible, enhancing the credibility of the data generated.
STEPS TO OBTAIN GLP CERTIFICATION
Novice organizations face a significant challenge in implementing the OECD Principles of Good Laboratory Practice (GLP). The objective is to establish a sequential framework for implementing GLP. While there are multiple approaches to achieving GLP compliance, we recommend the following steps for implementing GLP:
- Organization: Conduct comprehensive GLP training for all staff members. Establish an organizational structure that includes designated management personnel, study directors, quality assurance personnel, and an archivist. Management should appoint individuals for these roles and establish a standardized format for handling personally identifiable information. Organize personnel records, prepare an SOP, analyze and revise staff organization charts and documents, designate a responsible person for managing the SOP system, and establish an SOP for the archiving process.
- Responsibility: Ensure the approval of protocols and study plans, provide access to SOPs, conduct studies under GLP principles, develop workflow SOPs for protocols, comply with SOP instructions, record raw data, and accurately interpret, analyze, document, and report the results.
- Facility: It ensures that the physical infrastructure, equipment, and environmental conditions meet GLP requirements. Implement appropriate maintenance, calibration, and validation procedures for laboratory equipment. Develop SOPs for facility management, equipment usage, and maintenance. Regularly inspect and audit the facility to ensure compliance with GLP guidelines.
- Quality Assurance Unit: To establish the Quality Assurance (QA) unit, develop an Operational Assessment (OA) program utilizing the approved protocol. Implement three inspection methods to identify and report deviations to the Study Director (SD) and management. Set up the QA unit and conduct training sessions for staff members to ensure their proficiency in verification and inspection techniques.
- Apparatus, Materials, and Reagents: Establishing clear guidelines for the identification, handling, and storage of all apparatus, materials, and reagents It includes specifying the use of reagents in procedures as outlined in Standard Operating Procedures (SOPs). Additionally, develop rules and SOPs for various tasks, such as solution preparation, to ensure consistent and accurate practices throughout the organization.
- Establishment: Establish rules for the acquisition and approval of raw data. Define the process for auditing raw data in all operating units and develop Standard Operating Procedures (SOPs) for verification and quality control (QC) tasks.
- Raw Data: Prepare validation protocols for systems requiring validation, identify and formally deploy validated systems, draft approved validation reports, and establish rules for organizing access rights through an SOP.
- Achieve Documentation: Review existing SOPs and compile a list of remaining SOPs. Develop a timeline for completing these SOPs, including authorship and revision time. Create a comprehensive calendar for ongoing studies. Conduct a second gap analysis to identify any remaining areas of non-compliance with GLP.
REQUIREMENTS FOR GLP CERTIFICATION
GLP accreditation encompasses several Key requirements similar to ISO 17025, with additional specifications. These requirements include:
- Test Facility Management (TFM): Effective management of the test facility, ensuring adherence to GLP principles and guidelines
- Study Director (SD): Appoint a study director who oversees the conduct of each study, ensuring compliance with GLP requirements.
- Archivist: Designating an archivist responsible for organizing and maintaining the test facility’s records and documentation
- Independent Quality Assurance Unit and QA Program: Establishing an independent quality assurance unit that monitors and audits the test facility’s activities to ensure compliance with GLP standards
- GLP-compliant study conduct and Study Inspection: Conducting studies in a manner that aligns with GLP guidelines and subjecting them to regular inspections to assess compliance
- GLP-compliant study documentation: Develop comprehensive study protocols, reports, and statements from the study director and quality assurance, following GLP guidelines.
- GLP Archive: Maintaining an archive system that securely stores test data and documentation for a minimum period of 15 years to ensure traceability and data integrity
- GLP Training: Providing appropriate training to personnel involved in GLP studies to ensure they are familiar with GLP principles, procedures, and requirements
GLP places significant emphasis on the traceability and safety of the original test data (raw data) and assigns clear responsibilities to individuals involved in the study process.
BENEFITS OF GLP CERTIFICATION
Adhering to Good Laboratory Practice (GLP) offers significant benefits for Data traceability, quality, and credibility. Additionally, it brings numerous benefits for both the laboratory and its customers. Here are the key points highlighting the benefits of GLP:
- Documented Trail and Traceability:
- The establishment of a documented trail ensures traceability for all measurements.
- Enables easy tracking and verification of data, enhancing transparency and accountability.
- Scientifically Sound Data:
- GLP ensures the generation of scientifically sound data of high quality, reliability, and credibility.
- Adherence to GLP principles promotes accurate and valid results, minimizing errors and discrepancies.
- Enhanced Confidence:
- Following GLP instills greater confidence in the reliability and trustworthiness of laboratory data.
- Stakeholders, including clients and regulatory bodies, have increased confidence in the data produced.
- Improved Accuracy:
- Adhering to GLP principles increases the production of right-first-time results.
- Minimizes errors reduces the need for repeated experiments and ensures data accuracy and validity.
- Increased Productivity:
- GLP practices contribute to enhanced overall productivity within the laboratory.
- Streamlining processes, minimizing errors, and optimizing resource utilization lead to improved efficiency.
- Enhanced Reputation:
- Following GLP standards enhances the laboratory’s reputation for delivering high-quality and reliable data.
- Builds trust among clients, regulatory authorities, and stakeholders in the laboratory’s capabilities.
- Reduced Re-work:
- Adherence to GLP reduces the need for rework and repeated experiments.
- Saves valuable time, effort, and resources by minimizing errors and ensuring data integrity.
- Efficient Investigations:
- GLP implementation reduces the time spent on non-revenue- earning investigations.
- Allows the laboratory to focus more on productive activities and scientific advancements.
Embracing GLP principles establishes a robust data trail, ensuring traceability and scientifically sound data. Benefits include increased data confidence, improved accuracy, enhanced productivity, a higher reputation, reduced rework, and efficient investigations. Adhering to GLP enables laboratories to consistently produce reliable results, meeting regulatory requirements and customer expectations.
ELIGIBILITY FOR GLP CERTIFICATION
GLP certification is a voluntary process applicable to industries, test facilities, and laboratories working with the mentioned chemicals and seeking approval from regulatory authorities before marketing their products. It is particularly relevant to organizations involved in the development, testing, and registration of pharmaceuticals, color additives, food additives, food packaging, medical devices, and other regulated products. By seeking GLP compliance certification, these entities demonstrate their commitment to adhering to the highest standards of laboratory practices, ensuring data integrity, and meeting regulatory requirements. GLP certification allows organizations to enhance their credibility, improve the quality and reliability of their data, and facilitate the approval process for their products, thereby benefiting both the organization and the regulatory authorities responsible for ensuring public health and safety.
GLP CERTIFICATION COST
The main factors affecting the cost of GLP certification are as follows:
- Reporting, Recordkeeping, Reading, and Understanding: These activities involve the documentation and management of data, results, and records, which contribute to the overall cost of GLP certification.
- Standard Operating Procedures (SOP): The development, implementation, and adherence to SOPs require resources and training, adding to the cost of GLP certification.
- Training: Training personnel on GLP principles and practices incurs additional costs.
- One-time Costs: Certain costs, such as initial setup and implementation of GLP compliance measures, are considered one-time costs but can be significant in the overall certification process.
- Annual Costs: Ongoing expenses related to reporting, recordkeeping, and other recurring activities contribute to the Annual cost of maintaining GLP certification.
- Number of Sponsors: The number of organizations or sponsors affected by the proposed rule directly impacts the average cost per sponsor. Increased sponsors lead to lower costs per sponsor, and conversely,
The cost of GLP certification is contingent upon diverse factors and subject to variation depending on the specific context and certification requirements.
THE DIFFICULTIES AND SOLUTIONS IN MAINTAINING GLP
Maintaining GLP compliance involves addressing various challenges in different areas. Here are the challenges to maintaining GLP and potential solutions for each:
Challenges and Solutions for Maintaining GLP:
- Inspection: Preparing for and undergoing Inspections by regulatory authorities
- Solution: Conduct regular internal audits, ensure proper documentation, and implement robust quality assurance measures.
- Quality Assurance: Maintaining a robust quality assurance program
- Solution: Implementing quality control measures, conducting regular audits, providing adequate training, and fostering a culture of quality consciousness.
- Management: Ensuring effective management for GLP compliance
- Solution: Establishing clear roles, ensuring adequate resources, and promoting a culture of compliance through communication and performance evaluations
- Animal Facilities: Meeting regulatory requirements for animal facilities
- Solution: Ensuring appropriate housing, hygiene, care, and ethical treatment, and providing training and supervision.
- Laboratory Equipment Areas: Proper equipment maintenance, calibration, and validation
- Solution: Develop equipment management programs, establish maintenance schedules, conduct regular calibrations, and ensure proper documentation.
- Training: Providing adequate training on GLP requirements
- Solution: Providing comprehensive initial and ongoing training, offering refresher courses, and conducting competency assessments
- Standard Operating Procedures (SOPs): Developing and maintaining valid SOPs
- Solution: Establishing a system for SOP development, review, approval, and distribution and ensuring compliance with documented procedures
- Data Management: Ensuring data integrity, storage, retrieval, and security
- Solution: Implementing robust electronic data management systems, ensuring backups, maintaining data integrity through audit trails, and following data archiving procedures
Addressing these challenges requires a proactive approach, commitment from management, and a dedicated quality management system. Regular training, communication, internal audits, and continuous improvement efforts are essential to maintaining GLP compliance and ensuring the generation of reliable scientific data.
DURATION OF GLP CERTIFICATION: HOW LONG DOES IT LAST?
GLP certification has a validity period of three years. The regulatory authorities conduct annual surveillance of the certified entity during this time to ensure ongoing compliance with GLP principles and requirements. The surveillance activities involve inspections, audits, and assessments to verify that the certified organization continues to adhere to the prescribed standards.
After three years, a reassessment evaluates compliance and performance to determine certification renewal. It includes examining laboratory practices, documentation, quality management, and adherence to GLP guidelines.
The validity of the GLP certificate assures stakeholders that the certified organization has consistently maintained compliance with the required standards over an extended period. It demonstrates the organization’s commitment to quality, integrity, and accountability in their laboratory studies, ensuring the reliability and trustworthiness of the generated data.
CERTPRO: YOUR GUIDE TO ACHIEVING GLP CERTIFICATION
CertPro specializes in assisting businesses to obtain GLP (Good Laboratory Practice) certification through comprehensive auditing, consulting, and certification services. With a team of experienced auditors and consultants, CertPro guides your business through the Certification process, ensuring compliance with GLP regulations and industry best practices. They assess your laboratory practices, identify areas for improvement, and help implement effective quality management systems. CertPro provides documentation support and expert guidance to ensure compliance with GLP requirements. By partnering with CertPro, your business can demonstrate its commitment to maintaining a higher standard of data integrity, accuracy, and reliability in laboratory operations. Achieving GLP certification with CertPro’s assistance enhances your reputation, instills confidence in customers and stakeholders, and positions your laboratory for compliance with regulatory requirements and industry expectations.
IS GLP CERTIFICATION MANDATORY?
GLP certification is not mandatory in all cases, but it is often required or highly recommended for organizations involved in nonclinical research and development, product testing, and regulatory submissions.
CAN A SMALL ORGANIZATION OBTAIN GLP CERTIFICATION?
Yes, GLP certification is available for organizations of all sizes. The requirements and processes may vary based on the organization’s scope and complexity, but small organizations can also achieve GLP certification by implementing the necessary systems and practices.
SHOULD testing FACILITY MANAGEMENT BE AN INDIVIDUAL OR A TEAM?
Under GLP principles, it is allowed to have either an individual or a team responsible for test facility management. In the case of a team, it is necessary to clearly define the management responsibilities assigned to each individual based on their roles within the facility. This documentation ensures clarity, defines communication lines, avoids conflicts of interest, and ensures compliance with the requirements of the GLP Principles.
IS IT PERMISSIBLE FOR THE HEAD OF TEST FACILITY MANAGEMENT TO ASSUME RESPONSIBILITY FOR QUALITY ASSURANCE?
No, assigning the responsibility of quality assurance to the head of test facility management would create a conflict of interest, resulting in non-compliance. In such cases, it is recommended to engage an external quality assurance function, especially for small test facilities.
ARE GLP INSPECTORS AUTHORIZED TO COMMENT ON STUDY-RELATED SCIENTIFIC ISSUES?
GLP inspectors may comment on study-related scientific issues depending on the specific circumstances. Deviations from the study plan methodology or issues impacting data validity fall under GLP concerns. When appropriate, the receiving authority’s assessor evaluates study design issues and advises informing them.
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