Good Laboratory Practices (GLP-REACH)
"GLP requirements are enforceable in the studies of registration of active ingredients and commercial products (pesticides, biocides, rodenticides, insecticides, fungicides, disinfectants, wood treatments, products of biological origin, etc.). Moreover, certification in the field of chemicals allows us to offer analytical services for the implementation of programs that comply with REACH legislation. Among the studies that are routinely performed:"
"5 Lots (determining the wealth of active ingredients in a compound or substance, taking into account 5 production batches)"
The purpose of these studies is to determine the wealth of active ingredients in a material or chemical substance, taking into account 5 production lots. In this way, this study evaluates the production homogeneity. These studies determine water contamination levels from known sources. This information is directed towards the registration of a product and preparation of a manufacturing safety record
"Dissipation of pesticides (to determine the persistence of an active ingredient / formulated on different arrays that can be contacted)"
The purpose of these studies is to determine the persistence of an active material or formulation in various matrices with which it might come into contact. Safety periods vary widely depending on the conditions that can be present.
Stability (accelerated, ambient temperature and low temperatures)
The purpose of this study is to determine the shelf life of a product by looking at how the product's wealth varies over time, simulating conditions that will be met during storage of the product. These studies have two phases: accelerated and ambient temperature.
The ambient temperature studies are performed by controlling temperature and humidity. These studies can last from 3 to 4 years, depending on the interests of the client and the product at hand. Accelerated studies last 15 days and the stored samples are placed in the warehouse at 129ºF ± 35ºF. Temperature variations con be performed but various exist due to where the product will be finally registered.
Determination of the wealth of active ingredients in any compound
The purpose of these studies is to determine the wealth of active ingredients in material or chemical substances. This determination can be made for in any material. Each determination can have various purposes: Evaluate homogeneity of production, establish stability of ingredients over time, assure that a commercial container actually contains what its safety label states, and endorsement by manufacturers of the viability of their storage techniques as per GLP procedures (for reproducibility of results).
Identification and characterization of physicochemical properties
The purpose of these studies is the characterization of physicochemical properties of any chemical substance. The characterization of these properties is required for the registration of chemical products imported or distributed at a rate greater than one ton per year. One of the priorities of REACH legislation is to keep such substances from causing harm to public health and the environment.
AGQ recommends the elaboration of these studies under GLP guidelines to assure reliability of results and to avoid registration problems.
