Glp

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