Good Laboratory Practice
GLP, Regulations, compliance, Testing, certification, reports,
Guidelines, Manuals
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- Good Laboratory
Practice (GLP) deals with the organization, process and conditions
under which laboratory studies are planned, performed, monitored,
recorded and reported.
GLP data are intended to promote the quality and validity of test
data.
- The US FDA introduced
GLP regulations
- Organization for
Economic Cooperation and Development (OECD) published a compilation
of Good Laboratory Practices. OECD member countries have since
incorporated GLP into their own legislations
- GLP is needed for: Non
clinical safety studies of development of drugs
Agricultural pesticide development
Development of toxic chemicals
Food control (food additives)
Test of substance with regard to
explosive hazards
- The GLPs apply to the
chemical procedures used to characterize the test article, to
determine the stability of the test article and its mixtures, and to
determine the homogeneity and concentration of test article
mixtures.
- The GLPs apply to the
chemical
procedures used to analyze specimens
- The GLPs do not apply
to the work done to develop chemical methods of analysis or to
establish the
specifications of a test article.
- Standard operating
procedures (SOPs) are written procedures for a laboratory’s program.
They define how to carry out protocol-specified activities
- One of the key
requirements of GLP and GMP regulations for analytical laboratories
is validation: equipment hardware, software, systems, methods
and data. Validation is not a one-time event but ongoing covering
all phases of a product or process.
- GLP applies to the
non-clinical safety testing of test items contained in the
pharmaceutical products, pesticide products, cosmetic products,
veterinary drugs, as well as food addtitives, feed additives,
herbal/plant extracts
- GLP Certification is
voluntary and any tesing facility in India which undertakes
non-clinical health and environmental safety studies will be
eligible to seek GLP Certification
- Government of India
established the National GLP Compliance Monitoring Authority (NGCMA)
under the under Ministry of Science and Technology, Department of
Science and Technology, New Delhi
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Basics & Background Information
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Chemical Industry - India
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Principles of Good Laboratory Practice
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About GLP
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European REACH Congress
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Registration Committee (RC)
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FAQ
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World Crop Protection News
Technology
Guidance
- Manual for analysis of pesticide
residue in Food
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Guidance for the applicability of the
principles of GLP
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Book of Guidance - GLP
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Training Manual
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Guidance document for Pesticide
registration
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Guide Book - Quality practices
for regulated non-clinical
research and development -
Application for Registration
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Regulations Brochure
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Manual for Inspectors monitoring
complaisance with principles of GLP
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Harmonization of Laboratory parameters for
analysis food samples
Consultancy
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Legal & Business Support services
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Laboratory technology services
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Research and testing services in the
field of product safety assessment
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Contract Research Services
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Contract Research organization
Test Facilities
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Product Safety Labs
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Chemical Testing - Canada
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Environmental testing
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GLP toxicology services
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List of GLP Certified Test Facilities in
India
Certificates
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GLP Certificate
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Certificate - Chemical substances
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Certificate of GLP Compliance
Special Products
Reports
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Quality Control of Pesticide Products
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Captan fungicide
-
Captan - Evaluation for acute reference
dose
-
The Reregistration Eligibility Decision
document for captan
- Company Profile
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