Pesticide Registration GLP 5 Batch Analysis

Pesticide Registration GLP 5 Batch Analysis is a fundamental step in the registration process, providing regulatory agencies with the essential data needed to assess the quality and consistency of pesticide formulations.

Regulatory directive requiring analysis of 5 batches
Europe - Regulation (EC) 1107/2009, referencing SANCO 3030/99 rev.4.
United States - The U.S. Environmental Protection Agency (EPA) Pesticide Assessment Guidelines OCSPP 830.1700 and 830.1800 in accordance with 40 CFR Part 158OPPTS.
Brazil - Brazilian Association of Technical Standards (ABNT) NBR 14029: 2005, NBR 14029-2016.
Argentina - The National Service for Agri-Food Health and Quality (SENASA) requirements.
Mexico - The Federal Commission for Protection against Sanitary Risks (COFEPRIS) requirements.
Worldwide - The Food and Agriculture Organization (FAO) and the International Union of Pure and Applied Chemistry (IUPAC) requirements.
Step-by-step process of 5-batch analysis
Protheragen-ING Lab follows a phased process, moving to the next phase based on previously obtained results and providing a full GLP report for submission to the appropriate regulatory agencies.

Step 1: Screening of Batches

Using GC (FID), HPLC (UV), and Ion Chromatography, we can quickly and easily screen your pesticide batches in a semi-quantitative procedure to find ingredients exceeding 0.06% w/w.

Step 2: Impurity Identification and Separation

In the event that contaminants are found during the screening procedure, they are identified and separated by additional analysis. Impurities can be identified and their composition and structure can be ascertained by the use of sophisticated analytical techniques such as GC-MS, LC-MS-MS, and NMR.

Step 3: Determination of Analytical Reference Standards

To guarantee accurate results, these analytical reference standards are employed as benchmarks throughout the analysis. On request, we can collect reference standards from other sources; alternatively, we can provide analytical reference standards from our synthesis laboratory, saving you both time and money. Our synthesis lab guarantees quality and helps to avoid delays.

Step 4: Analytical Method Development

Analytical methods are developed to determine the concentrations of active ingredients and impurities present in a pesticide batch. This includes selecting appropriate analytical techniques, optimizing instrument parameters, and determining appropriate sample preparation methods.

Step 5: Method validation according to regulations

All methods developed are validated according to the EU SANCO 3030/99 rev.4 guidelines and all other requirements of the submitting region.

Step 6: Quantitative Analysis of The Active Ingredient and All Components

Quantitative analysis of the pesticide batch's active ingredient and all other ingredients (such as solvents and contaminants) utilizing ion chromatography, GC (FID), and HPLC (UV).

Step 7: Critical Stage Checks

Throughout the batch analysis process, QA checks and monitors key stages to ensure accuracy, reliability and compliance.

Step 8: Full GLP Report

Once the analysis is complete, a comprehensive GLP report is prepared. This report includes detailed information on the analytical methods used, validation data, quantitative analysis results, impurity profiles, and any deviations or problems encountered during the analysis.

Step 9: Post-Submission Support

After submitting a pesticide registration application, we can provide post-submission support. This support can include addressing regulatory inquiries, providing additional data or information upon request, and assisting with any further analysis or clarification required by the regulatory agency.