TITLE: GOOD LABORATORY PRACTICE (GLP)
SOP NO.:
QC00X-01
Effective Date:
DD/MM/YYYY
Company Logo
Supersedes :
QC00X-00
Page No.:
01 of end
Department:
Quality Control
Review Date:
DD/MM/YY
OBJECTIVE :
·To lay down a procedure for Good laboratory Practice guidelines during the analysisat the Quality control Department.
SCOPE:
·This SOP is applicable for the Staff of the Quality Control Department to follow the Good Laboratory Practice (GLP) guidelines implemented in the Quality Control Department in Evertogen Life Sciences Limited, Jadcherla.
RESPONSIBILTY(S):
·QC Executive / Executive: To follow the SOP.
·QC Head For the implementation and compliance of the SOP.
ABBREVIATIONS:
·SOP: Standard Operating Procedure
DEFINITIONS:
·Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which studies are planned,performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can assessed for pharmaceuticals, industrial chemicals, cosmetics, food and feed additives and biocides.
·GLP assures regulatory authorities that the data submitted are a true reflection Of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.
·Activity: One of the many different procedures that can be carried outwithin thelaboratories of the Quality Control Department such as a particular study,experiment, practical session or calibration of an instrument for example.
·Archive: An indexed collection of historical records and out of date documentation.
·Personnel: Refers to staff members making use of the laboratory.
PROCEDURE:
FACILITIES:
·Ensure that test facility is of suitable size and location to meet the roquirements of the activities that are carried out and to minimise any disturbances
Ensure that test facility has areas for the isolation of substances. or organisms which are to bio- hazardous.
·Ensure that the facility has provisions to regulate environmental conditions such asand humidity.
Collect, store and dispose of waste appropriately so as not to interfere with theintegrity of an activity.
·Ensure that suitable areas are available för supplies and equipment and that these areas provide protection against infestation, contamination and deterioration.
PERSONNEL:
·Ensure that each individual engaged in the conduct of orresponsible for the supervision of an activity has an educational background, training and experience to enable each individual to perform the assigned functions.
·Ensure that there is a sufficient number of personnel for theproper conduct of each activity.
·Ensure that personnel take necessary personal protective precautions designed to avoid contamination of test and products
·Ensure that individuals engaged in an activity wear appropriate clothing for the duties they are to perform.
·Report any critical condition’s that may be considered to have an adverse effect on Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.
EQUIPMENTS, MATERIALS AND REAGENTS:
·Ensure that the equipment used in the measurement or assessment of data is suitably located, of appropriate design and of adequate capacity to function according to the activities that are carried out.
·Periodically inspect, clean, maintain and calibrate the equipment according to each equipment’s SOP and ensure that records of such activities are maintained in each respective equipment logbook.
·Ensure that the equipment and other materials present do not interfere with test systems.
·Light should be adequate
·Electrical system in laboratory must not be over loaded. Voltage stabilizer must be provided to protect delicate instmments.
TEST AND REFERENCE SUBSTANCES
·Determine the identity, strength, purity and composition which define the test and reference substance and ensure that these are documented.
·Label each storage container for the test and reference substance with name, codenumber, batch number, and expiry date and storage conditions.
·Clean the working table, instruments before & after completion of analysis.
·Ensure that the temperature during dilution, at the time of volumetric measurement and standardization is maintained i. e. at about 25 C.
·Not enter in the areas which are restricted for entrance.
·Label the glassware. which is in use,
·Wipe the pipette before inserting in the volumetric flask.
·Make the dilutions carefully & accurately.
·Do not use contaminated sucker / rubber bulb.
·Make up the volume of the solution when it is at room temperature.
·Follow the methods properly & crosscheck once.
·Never leave any chemical reaction taking place on the gas i.e. boiling, distillation, refluxing unattended.
·Always fill burette taking it away from the stand in to the hand and using a glassfunnel. Adjust the reading to zero before starting titration.
·Use approximately 0.1 ml of indicator, during titration or standardization, unless otherwise specified.
·Never return unused reagent to the reagent container. Contamination of the whole
·reagent supply is more costly than the small amount of reagent discarded.
·Never stick a spatula in to a container of a solid reagent. Always roll the container to deliver the reagent in a controlled manner to the receiving
·Crosscheck the exactness of instrument method / program & sequence with respect to the method of analysis. Crosscheck the exactness of sequence with respect to the samples loaded in auto sampler.
·Avoid glassware breakage. Upon bivakage of any glassware intimate to your respective supervisor so that the for the same can be raised to avoid shortage of glassware.
·Record the values & results online.
·Check the entered values & figures for correctness online,
·Calculate the results using correct formula (as per method of analysis) & recheck once online.
·Do not overwrite the wrong entry. Cross it out with a line permitting the reading of
·original entry. Clearly write the correct entry near the cross out & sign the dataalong with the date on which correction is made.
·Do not leave the blank spaces. Draw a line across the page from left to right.
·All the document entries shall be made With indelible blue ink in clear & legible hand writing.
·Columns or rows not required shall be marked as ‘N.A.’.
·Use correct path of validated excel sheet for calculation of results.
·Ensure that the usage and consumption entry is made in the instrument and column log book and working standard log book respectively.
·Ensure that the test facility has a set of approved and revised SOPs.
·Review each SOP every 3 years from its date of approval or before if deemed necessary.
·Ensure that the personnel have access to the appropriate SOPs for during their activity and also to comply with the instructions given in these documents.
·Ensure that SOPS, manuals, published text books, analytical methods and articles relative to the activities that are being undertaken are available.
·Ensure that the latest authorized copy of each SOP is available in each laboratory. Justify, document and acknowledge any deviations from an SOP.
·SCHEDULE: Not Applicable.
·REFERENCE SOPs: Not Applicable.
·FORMATS/RECORDS: Not Applicable
·REFERENCE: 21 CFR Part 58.
REVISION HISTORY
Version
Effective
Summary of Revision
0.0
DD/MM/YYYY
New SOP
END O F THE DOCUMENT
Prepared By Checked By Approved By
Sign & Date
Name & Department QA Executive QC Manager QA Manager