Good Laboratory Practice - Pharmasquare

Good Laboratory

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

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

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

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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