Good Laboratory Practices

✔ If experimental work is conducted in

compliance with GLP, with or without the
use of computer, it should be possible for an
inspector, maybe four or five years hence,
to look at the records of the work and
determine easily why, how and by whom
the work was done, who was in control,
what equipment was used, the results
obtained, any problems that were
encountered and how they were solved.
 Good Laboratory Practices
Records
✔ All stability testing performed on API’s
✔ OOS Investigations
✔ Periodic calibration of laboratory Instruments
✔ Preparation and testing of laboratory reference
standards, reagents and standard solutions
✔ Modifications to an established analytical method
✔ Complete data derived from all tests
✔ Description of samples
 Good Laboratory Practices
✔ Reference to each method used
✔ Statement or weight or measure
✔ Complete record of raw data including
graphs, charts
✔ Record of calculations
✔ Statement of test results
✔ Initials or Signatures of analyst
✔ Initials or Signatures of 2nd person
 Good Laboratory Practices
✔ Specifications
✔ Standards
✔ Sampling plans
✔ Test procedures
✔ Reference standards
✔ Working standards
✔ Calibration
✔ Volumetric Solutions
 Good Laboratory Practices
✔ General Solutions
✔ Working standard protocols
✔ SOP’s
✔ Method validation
✔ Personnel validation
✔ IQ/OQ/PQ
✔ Stability data
✔ Label control
 Good Laboratory Practices
✔ Make all the entries in the approved /
authorised protocols only
✔ Keep only the required chromatograms
✔ Enter the weights / observations
immediately in the protocol
✔ Check the validity of the reagents and
volumetric solutions
✔ Always sign and date the chromatograms
 Good Laboratory Practices
✔ Do not overwrite
✔ Report all deviations and abnormalities to
the superior
✔ Check for the cleanliness of the instrument
before use
✔ Ensure that calibrations of all instruments
are done in time
✔ Prepare mobile phase freshly
 Good Laboratory Practices
✔ Make the entries of columns in the log book
✔ Maintain the instrument use log book
✔ Store the reference standards and working
standards properly
✔ Label all the glasswares in the laboratory
✔ Clean the glasswares as per procedure and
ensure it is clean and dry before use
✔ Follow specifications always
 Good Laboratory Practices
✔ Follow Standard Testing Procedures
✔ Inform all the OOS to the superiors
✔ Wear safety apparels wherever required
✔ Perform sampling as per procedure
✔ Destroy the excess samples
✔ Store the reference samples appropriately
✔ Do not give the results unless report is
completed
 Good Laboratory Practices
✔ Destroy the excess samples immediately
✔ Keep the samples to be analysed in
appropriate place
✔ Use always calibrated glasswares
✔ Use clean and dry scoops for sampling
✔ Always keep the laboratory clean
✔ Check for the current lots of reference
standards