Frequently Asked Questions

Good Experimental Practice is a quality control system for the conducting and reporting of efficacy and phytotoxicity trials in accordance with EPPO standards PP1/181 and PP1/152. It covers various aspects, such as the conditions under which trials should be planned, conducted, assessed, recorded and interpreted so that results are comparable and reliable.

GEP was officially introduced to South Africa by the promulgation of the Regulations relating to agricultural remedies in August 2023 under the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act No. 36 of 1947) to align South Africa with international best practice and to improve the quality and credibility of efficacy and phytotoxicity data submitted in support of agricultural remedy registrations. The added benefit of GEP is that the regulatory process becomes more transparent, predictable and creates the potential for mutual recognition of data between regulatory authorities of different countries.

GEP is only applicable to efficacy and phytotoxicity trials conducted in support of agricultural remedy registrations (L registrations) under Act No 36 of 1947.

Residue trials are not governed by GEP – the quality control system used for residue trials is OECD GLP which is applicable to all non-clinical health and environmental studies.

Seeing as GEP was introduced via the Regulations relating to agricultural remedies, GEP is currently only a legal requirement for the registration of products falling into the description of an agricultural remedy under the Act:

Any chemical substance or biological remedy, or any mixture or combination of any substance or remedy intended or offered to be used for the destruction, control, repelling, attraction or prevention of any undesired microbe, alga, nematode, fungus, insect, plant, vertebrate, invertebrate, or any product thereof, plant growth regulators, defoliants, desiccants or legume inoculants.

Trial facilities must be a member of GEPSA, follow EPPO and GEPSA SOPs (as applicable) when conducting trials and successfully pass an independent audit. Seeing as GEP compliance is a new requirement in South Africa, the implementation thereof will be phased and the audit checklist and requirements for compliance will be updated by GEPSA regularly, until all aspects of GEP compliance is implemented in South Africa.

It is unlikely that GEP requirements will be in conflict with registration guidelines. However, in the event of uncertainty, registration guidelines will take precedence over GEP standards. Where conflicts are detected, please inform GEPSA as soon as possible to address the matter with the Registrar (Act 36 of 1947).

All facilities that conduct efficacy and/or phytotoxicity trials for the purpose of registering an agricultural remedy in South Africa under the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act No. 36 of 1947), must undergo a GEPSA audit to demonstrate GEP compliance. Registration holders/applicants that do not conduct their own trials, but outsource trials to other service providers, do not need to undergo a GEPSA audit, only the facility physically conducting the trials must be audited. It is however important for the registration holder/applicant to subscribe to the EPPO and GEPSA databases to access the most recent standard operating procedures for conducting trials in accordance with GEP.

GEP will be implemented in South Africa in a phased approach. This means that the requirements for GEP compliance will be updated regularly until all aspects of GEP are covered by the GEPSA scheme. During the first few years of implementation while the scheme is continuously being updated to increase the requirements for compliance, audits will be conducted on an annual basis. Once GEP is fully implemented in South Africa and a facility passes a GEPSA audit with no major non-conformances, audits may be conducted at less regular intervals.

It is imperative that audits are conducted by professional, independent auditors, who measures GEP compliance of facilities in a consistent, predictable way. For this purpose, GEPSA has partnered with an independent auditing firm, NSF which is a multinational company specialising in testing, auditing and providing technical services to a variety of industries.

GEP is a new requirement in South Africa and will be implemented in various phases. This means the requirements for compliance will be increased/updated over time until full compliance with GEP is reached. The audit checklist for the next phase of implementation will be shared by GEPSA in advance, to ensure facilities have sufficient time to prepare for their next audit.

If an auditor finds a facility non-compliant with certain requirements in the GEPSA scheme, these findings will be documented and communicated with the facility. Corrective actions will be decided on between the facility and auditor which must be addressed in an agreed timeframe to receive or maintain a GEP conformance letter. Major non-conformances that are not addressed in the agreed timeframe could lead to retraction of the facility’s conformance letter. Reinstatement is only possible once the non-conformances have been addressed and the facility has undergone a successful audit to confirm this. Facilities may also appeal the auditor’s decision in which case the matter will be escalated for further investigation.

Before the official audit, facilities should have their own internal audits to ensure compliance with the GEPSA scheme and audit checklist. Proof of an internal audit must be provided before an external audit can be reserved. The audit checklist for the next phase of implementation will be shared by GEPSA in advance, to ensure facilities have sufficient time to prepare for their next audit.

Further preparation include:

• Always use EPPO standards and GEPSA SOPs, as applicable, to plan and conduct trials

• Draft internal facility-based SOPs for all processes followed at the facility when conducting trials

• Ensure staff are sufficiently trained and competent for their allocated tasks

• Maintain complete and accurate records

The principles of GEP remain the same, regardless of referring to EPPO or GEPSA. GEP was developed by the EPPO and GEPSA is implementing GEP in South Africa according to the same principles as described by the EPPO, however there are a few minor differences to take note of:

• GEP is newly introduced to South Africa, consequently it is being implemented in a phased manner. Therefore, GEPSA will not require trial facilities to be fully compliant with all the GEP requirements as described by the EPPO from the initial implementation date. The requirements for GEP compliance under GEPSA will increase over time until the implementation of GEP in South Africa is fully aligned with that of the EPPO and other international standards.

• The EPPO has developed general and specific standards for use in the EPPO region. In most instances, these standards will be implemented by GEPSA without amendment. However, due to geographical differences between the EPPO region and South Africa, resulting in different crops, cultivars and pest species, there are cases where existing EPPO standards are not fit for local South African conditions, or in some cases no EPPO standard exists (for example in the case of endemic crops or pests that do not occur in the EPPO region). In these cases, GEPSA will amend EPPO standards or draft new local standards to suit local conditions.

• In the EPPO region, GEP compliance is enforced by the government, meaning government officials conduct audits of trial facilities. In South Africa, trial facilities are not audited by government officials, but by external independent auditors. Although the government will not conduct audits, they may conduct inspections of GEP trial facilities at any time to verify compliance – such inspections will however be communicated to facilities beforehand.

Don’t worry, we’ve got you covered. Below is a list of abbreviations, terms and general references used on the GEPSA website along with explanations.