regulatory affairs services - sgs...the art” glp laboratories. the regulatory team will place,...
TRANSCRIPT
REGULATORY AFFAIRS SERVICES
WWW.SGS.COM
METHODS OF ANALYSIS
The analytical methods used in various sections of a registration package are the “foundation” to any dossier submission. It is essential that such methods are seen to be accurate, precise and robust, and with sufficient validation to ensure that they are fit for purpose. SGS experts will ensure that any methods included in submission dossiers meet all national and international regulatory guidelines.
The SGS regulatory team consists of highly experienced expert scientists representing each regulatory discipline, including specific expertise in methods of analysis. Additional expertise in method development and validation is offered in the global network of “state of the art” GLP laboratories. The regulatory team will place, manage and oversee all aspects of the conduct of method of analysis studies. The team can also offer technical support, if and when needed, in all analytical disciplines and techniques.
Methods of analysis are required for all aspects of registration of Plant Protection Products (PPP), from analysis of the active substance to set the specification to the determination of the amounts of product entering the environment and humans. For the active substance it is necessary to determine the levels of impurities plus the purity of the active substance. Once a validated method is finalised the specification for the active substance is determined based on the 5 batch analysis from non sequential production batches. This analysis can be carried out in specific laboratories within the SGS network in order to ensure the impossibility of cross contamination with the more sensitive determinations for residues.
Once a fully validated method has been developed for the active substance, a method for determination of the active within the formulated product is required, specifically for quality control and storage stability determination of the PPP.
The fate of the PPP within the environment and within humans is determined using highly specific, sensitive methods of analysis for the active substance and its metabolites as determined in radio labelled metabolism and E-fate studies. Methods are validated using a minimum of 5 replicates at specific levels (usually LOQ and 10 x LOQ) to demonstrate the validity of a given method, with recoveries within the guideline range of 70%-120%. Most methods are developed using modern techniques such as LC/MS/MS where two transitions are selected in order to demonstrate the specificity of a given methods. However where it is not possible to use these techniques a second confirmatory method is also developed and validated.
With the availability of the large network of laboratories within SGS it is possible to complete the Independent Laboratory Validation (ILV) of validated methods internally. The requirement is that the second laboratory has not had any previous experience with a given product determination, therefore the methods are routinely developed in a chosen laboratory and the ILV completed in a second GLP laboratory.
INDEPENDENCEINTEGRITYTRUSTRELIABILITYQUALITY
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 70 000 employees, SGS operates a network of over 1 350 offices and laboratories around the world.
SGS SERVICESSGS CAPABILITIESSGS has a number of state of the art laboratories in strategic regions of the World. The laboratories are accredited for a wide range of analytical determinations, fulfilling all the key requirements in method development and validation. SGS can meet all the regulatory requirements for methods of analysis and validation within the Global network.
The SGS regulatory team have extensive experience in preparing dossiers to establish a technical specification for plant protection products. There are experts with over 25 years experience in all aspects of method development, method validation and conduct of the various regulatory studies using these methods. In view of the fact that regulatory authorities are placing increasing demands upon applicants in order to ensure that methods are fit for purpose; SGS’s experts guarantee a high quality dossier.
SGS REGULATORY TEAM OFFERS:
• Placing the method determination within a suitable laboratory
• Technical advice on method refinement
• Continuous monitoring of the progress throughout the technical phase
• Assessment of the final report • Expert advice on alternative
techniques • Preparing the registration dossier to
the highest quality standards
WHY SGS• Global network of GLP accredited
laboratories
• Internal ILV method verification
• Technical advice on method refinement and development
• Confirmatory method techniques
• Unparalleled expertise
• State-of-the-art laboratories
ANALYTICAL METHODS
Analytical Standards and Samples
Methods for the Analysis of the Plant Protection Product
Description of Analytical Methods for the Determination of Residues in Crops
Other/Special Studies
Description of Methods for the Analysis of Soil
Description of Methods for the Analysis of Sediment
Description of Methods for the Analysis of
Water
Description of Methods for the Analysis of
Air
Description of Methods for the Analysis of
Body Fluids and Tissues
Development of Active substance
Product Chemistry Package Active substance
Manufacturing Process
Specification5-Batch Analysis
ANALYTICAL METHODS
Flow chart with chemical equations for each anticipated chemical reaction
Description of the manufacturing processFurther details, depending on country-specific requirements
Product Package Formulation
Content of the Active substance in the quantification of residues as determined in the metabolism studies
metabolites
• Soil • Water • Sediment • Air • Body fluids • Animal products
ANALYTICAL METHODS
Determination of active substance and
Development of Formulation
REGULATORY GLP LABORATORY SITES
To contact us:E: [email protected]/SeedAndCrop
WWW.SGS.COM
© S
GS
GR
OU
P M
AN
AG
EM
EN
T SA
– 2
012
– A
ll rig
hts
rese
rved
– S
GS
Bra
nd is
a r
egis
tere
d tr
adem
ark
of S
GS
GR
OU
P M
AN
AG
EM
EN
T SA