Good Laboratory Practice
               GLP, Regulations, compliance, Testing, certification, reports, Guidelines, Manuals
 
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Information @ a Glance Contents on the CD ROM
  • 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
Basics & Background Information
  • Chemical Industry - India
  • Principles of Good Laboratory Practice
  • About GLP
  • European REACH Congress
  • Registration Committee (RC)
  • FAQ
  • World Crop Protection News

Technology Guidance

  • Manual for analysis of pesticide residue in Food
  • Guidance for the applicability of the principles of GLP
  • Book of Guidance - GLP
  • Training Manual
  • Guidance document for Pesticide registration
  • Guide Book - Quality practices
    for regulated non-clinical
    research and development
  • Application for Registration
  • Regulations Brochure
  • Manual for Inspectors monitoring complaisance with principles of GLP
  • Harmonization of Laboratory parameters for analysis food samples

Consultancy

  • Legal & Business Support services
  • Laboratory technology services
  • Research and testing services in the
    field of product safety assessment
  • Contract Research Services
  • Contract Research organization

Test Facilities

  • Product Safety Labs
  • Chemical Testing - Canada
  • Environmental testing
  • GLP toxicology services
  • List of GLP Certified Test Facilities in India

Certificates

  • GLP Certificate
  • Certificate - Chemical substances
  • Certificate of GLP Compliance

Special  Products Reports

  • Quality Control of Pesticide Products
  • Captan fungicide
  • Captan - Evaluation for acute reference dose
  • The Reregistration Eligibility Decision document for captan
  • Company Profile

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