GEP Certification
Good Experimental Practice
What is GEP Certification?
“Good Experimental Practice” (GEP) certification is a designation that demonstrates an organization’s adherence to best practices and ethical standards in the conduct of experiments and scientific research. GEP is often associated with industries and sectors where experimentation plays a crucial role, such as pharmaceuticals, biotechnology, agriculture, and environmental science.
GEP certification signifies that an organization follows established guidelines, protocols, and regulations governing experimental practices. It emphasizes ethical considerations in experimental design, implementation, and reporting, ensuring the integrity, reliability, and reproducibility of experimental results.
Key aspects of GEP certification include compliance with standards, ethical conduct, quality assurance, documentation, training, and continuous improvement. Certified organizations prioritize ethical considerations, maintain robust quality assurance measures, and adhere to comprehensive documentation and record-keeping practices. They also invest in training and education to ensure personnel possess the necessary knowledge and skills for conducting experiments effectively.
By obtaining GEP certification, organizations demonstrate their commitment to upholding high standards of scientific conduct, ethical integrity, and quality in experimental research. This enhances trust among stakeholders, promotes collaboration, and contributes to the advancement of knowledge and innovation in various scientific disciplines.
Benefits of GEP Certification
Enhanced Credibility
GEP certification demonstrates an organization's commitment to upholding rigorous standards of scientific conduct and ethical integrity. This enhances the organization's credibility and reputation within the scientific community and among stakeholders.
Improved Quality Assurance
GEP-certified organizations implement robust quality assurance measures to ensure the accuracy, reliability, and reproducibility of experimental results. This leads to higher-quality research outcomes and strengthens confidence in the validity of findings.
Ethical Integrity
GEP certification emphasizes ethical considerations throughout the experimental process, including participant consent, animal welfare (if applicable), and avoidance of conflicts of interest. This promotes ethical integrity and trustworthiness in research practices.
Regulatory Compliance
GEP-certified organizations are more likely to meet regulatory requirements and standards set forth by governmental agencies, industry associations, and international bodies. Compliance with regulations enhances the organization's ability to navigate legal and regulatory frameworks effectively.
Risk Mitigation
By adhering to GEP principles and guidelines, organizations can mitigate risks associated with experimental research, including errors, biases, and safety concerns. This helps to protect the well-being of research subjects, personnel, and the environment.
Competitive Advantage
GEP certification differentiates organizations as leaders in the field of experimental research, giving them a competitive edge when seeking funding, partnerships, and collaborations. It also enhances their attractiveness to stakeholders who prioritize ethical and high-quality research practices.
Who can get GEP Certification?
Research Institutions
Universities, colleges, and other academic institutions conducting experimental research in various fields such as biology, chemistry, physics, and engineering.
Pharmaceutical Companies
Organizations involved in the research and development of pharmaceutical products, including drug discovery, clinical trials, and regulatory submissions.
Biotechnology Firms
Companies engaged in biotechnological research and development, including genetic engineering, bioprocessing, and biopharmaceutical production.
Agricultural Research Organizations
Institutions focusing on agricultural science, crop breeding, animal husbandry, and sustainable farming practices.
Environmental Research Agencies
Organizations studying environmental issues such as climate change, pollution, biodiversity conservation, and ecosystem restoration.
Government Research Laboratories
Public-sector institutions conducting scientific research in areas such as defense, health, energy, and national security.
Contract Research Organizations (CROs)
Companies providing outsourced research services to pharmaceutical, biotechnology, and other industries, including preclinical testing, clinical research, and regulatory support.
Non-governmental Organizations (NGOs)
Non-profit organizations involved in scientific research, advocacy, and policy development related to health, environment, and social issues.
Medical Research Centers
Facilities specializing in medical research, including hospitals, clinics, and research institutes conducting studies on diseases, treatments, and healthcare interventions.
Industrial research and development (R&D) departments
Departments within manufacturing companies conducting research to improve products, processes, and technologies.
Certification Bodies
Organizations authorized to conduct GACP audits and certify compliance with GACP standards, ensuring impartiality, competence, and adherence to accreditation requirements.
Research Institutions and Universities
Academic institutions conducting research on agricultural practices, botanicals, or natural products, incorporating GACP principles into their research protocols and projects.
Validity of GEP Certification
GEP certification is typically valid for a specified period, often 3 years, after which organizations must undergo recertification to maintain their certified status.
Documents Required for GEP Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of GEP Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the GAP between existing system related to GEP requirements
- Selecting the appropriate certification Body
- Based on the scope of your business & certification Body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- GEP Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to GEP requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Self Certification/NoBo
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the certification Body
Week 12
Self Certification/NoBo
- GEP certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
Who can issue the GEP Certification?
FAQ
GEP certification is a designation that demonstrates an organization’s adherence to established standards, protocols, and ethical principles in the conduct of experiments and scientific research.
Research institutions, pharmaceutical companies, biotechnology firms, agricultural research organizations, environmental research agencies, government laboratories, contract research organizations (CROs), NGOs, medical research centers, and industrial R&D departments can seek GEP certification.
Benefits include enhanced credibility, improved quality assurance, ethical integrity, regulatory compliance, risk mitigation, competitive advantage, collaboration opportunities, global recognition, and public trust.
Organizations undergo an assessment process conducted by a certification body to evaluate their compliance with GEP standards and guidelines. Successful completion of the assessment results in GEP certification.
GEP certification typically covers standards, guidelines, and regulations relevant to the organization’s field of research, such as those set forth by governmental agencies, industry associations, and international bodies.
GEP certification is typically valid for a specified period, often three years, after which organizations must undergo recertification to maintain their certified status.
Organizations must demonstrate ongoing compliance with GEP standards and guidelines through regular audits and assessments conducted by the certification body. Continuous improvement of experimental practices is also essential for maintaining certification.
You can verify an organization’s GEP certification by checking with the certification body that issued the certification or by consulting publicly available directories of certified organizations.