Implementation of GEP in South Africa

DEAR INDUSTRY STAKEHOLDER

Good Experimental Practice (GEP) is an industry-wide Quality Management System designed to standardize the conduct of efficacy and phytotoxicity trials, thereby enhancing their quality and reliability. In South Africa, the system will be implemented based on the EPPO GEP framework.

1. Implementation Timeline and Core Principles.

Effective 25 August 2025, all efficacy and phytotoxicity studies conducted for the registration of Agricultural Remedies under Act No. 36 of 1947 must be compliant with GEP. The GEP framework is built on the following core principles for field trials:

• Trial Protocol: A detailed and standardized plan that defines objectives, methods, treatments, and assessment criteria to ensure consistency and reproducibility across all trials.

• Qualified Personnel: All individuals involved in the trials must possess the necessary training, expertise, and resources. GEPSA will provide a platform for ongoing training.

• Suitable Equipment and Facilities: All equipment and facilities must be appropriate for the study, properly maintained, and calibrated, with corresponding records and operational procedures in place.

• Proper Recording and Documentation: All data, observations, and deviations from the protocol must be meticulously documented and archived to ensure traceability and verifiability.

• Safety and Legal Compliance: Adherence to all relevant safety and legal standards is mandatory to ensure environmental and industry sustainability.

2. Standards and Standard Operating Procedures (SOP’s).

The GEP system will utilize the EPPO PP1 standards for the conduct and reporting of efficacy and phytotoxicity studies. Where these standards are not applicable to the South African environment (e.g., for indigenous pests), the GEP Steering Committee has developed Industry Wide Standard Operating Procedures (SOPs) with the help of volunteers and industry experts. In addition, each organization or facility is required to develop its own internal Facility SOPs to detail its unique internal processes.

3. GEPSA: The Implementing and Accreditation Body.

The GEP Steering Committee has established a Not-for-Profit Company, GEPSA, to oversee the seamless implementation of GEP in South Africa. GEPSA's responsibilities include:

• Serving as a central repository for GEP resources and SOPs. These will be made available through the official GEPSA Website.

• Facilitating audits and accreditation processes for Facilities conducting Efficacy and Phytotoxicity trials.

• Providing personnel and arranging training.

Membership is required for all facilities conducting trials. The links to apply for GEPSA membership was circulated in an email on 19 June 2025. If an application was not yet submitted, please do so as a matter of urgency.

4. Audits and Financial Obligations.

All facilities conducting GEP efficacy and phytotoxicity trials will be subject to audits to ensure compliance with the core principles. This requirement does not apply to residue studies, which are governed by the Principles of OECD GLP.

The GEPSA Steering Committee has approved the following fee structure:

• GEPSA Membership Fee: A flat fee of R 10,000.00 per user per year, which includes access to the GEPSA website and South African Industry Wide SOPs. This payment will be due within three months.

• Turnover Levy: Facilities will also be required to budget an additional 0.65% levy based on their turnover for GEP efficacy and phytotoxicity trials. This payment will be due in four instalments invoiced quarterly.

• Facility Audit Fee: The estimated cost for each facility audit is R 15,000, covering the internal and external auditor functions, the audit process, and the review. Each facility will be invoiced independently for this and audits will commence shortly.

A detailed Audit Pack will be circulated to all applicants on 18 August 2025. Facilities are strongly encouraged to finalize their internal Standard Operating Procedures before this date.

Please mark 28 August 2025 in your calendar for the Detailed Information Session on the implementation of GEP in South Africa. This will be a virtual meeting held via MS Teams. The MS Teams meeting link is included below. Please click here to add the event to your calendar.

Sincerely yours,
The GEP Steering Committee