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Good-laboratory-1

Good Laboratory

quality system covering the organizational process and conditions under which non clinical laboratory studies.

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The principles of
"Good Laboratory Practice"

  • Testing and reference items
  • Equipment, materials, and reagents
  • Record keeping, reporting, storage, and retrieval
  • (Biological) test systems
  • Quality assurance procedures
  • Procedures for test/analysis methods
  • Computer-supported systems
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GLP-compliant testing and approval

The steps involved in testing:

  • The testing manager accepts the testing assignment and draws up a test plan for it.
  • Before the work can start, the quality assurance staff, testing manager, and party who commissioned the assignment must approve and sign the test plan.
  • The test plan includes the test procedure, test methods, and frequency of execution.
  • Its scope may also cover regular quality assurance inspections that monitor compliance with GLP principles.
  • A trial run of the test procedure is performed and the raw data documented.

The steps involved in approval:

  • It is not possible for approval to be granted until all the documentation is complete, and has been documented and archived.
  • If anything has not been documented, then the approval process automatically deems it as something that has not been performed.
  • Any missing documentation may result in the product failing to receive approval, incurring significant financial loss and wasted time.

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good laboratory

Quality System

Quality System

Quality System

good laboratory

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