Good Laboratory Practices (GLP)

by

Good Laboratory practices (GLP) in quality control

To define a procedure for Good Laboratory Practices (GLP).

 SCOPE

This SOP is applicable for quality control department for procedures for Good Laboratory Practices.

DEFINITION(S) & ABBREVIATION(S)

DEFINITION(S)

Good Laboratory Practices (GLP) is a quality system concerned with organizational process and conditions under which non-clinical health and environment safety studies are planned, performed, monitored recorded, archived and reported.

ABBREVIATION(S)

QAD     : Quality Assurance department

QCD     : Quality Control department

SOPs    : Standard Operating Procedures

GLP      : Good Laboratory Practices

ACS      : Analytical continuation sheet

CC No. : Change Control No.

RESPONSIBILITY

QC Person shall be responsible for:

To prepare the SOP

To follow the SOP for GLP in QC lab.

QC Head/Designee-QC shall be responsible for:

To provide training on approved procedure before implementation.

To ensure implementation of system as per defined SOP.

QA Personnel shall be responsible for:

To check and review the SOP.

To maintain the approved original copy of the SOP.

To maintain the records of control copy for issuance, retrieve and destruction.

Head QA/Designee shall be responsible for:

To approve new or revised SOP.

To ensure implementation of system as per defined SOP

Plant Head shall be responsible for:

To approve new or revised SOP

To ensure implementation of system as per defined SOP

PROCEDURE

SAFETY/PRECAUTION

Store chemicals safely as per MSDS.

Do not received the opened container and expired chemical.

Poisons and toxic chemical shall be stored under lock and key.

Use rubber suction bulb for manual pipetting, never suck the solution through mouth.

Always wear goggles or safety glasses.

 Personal Hygiene, Safety & House Keeping

All the persons working in labs should maintain the personnel hygienic conditions, with respect to haircut, trimmed nails, clean clothing, saving etc.

At the start of the day quality control department floors are first boomed & then wiped using disinfectants. These operations are carried out by housekeeping person under the

control of respective department as per SOP of Cleaning and sanitization procedure for laboratory .Subsequent to floor cleaning, Any waste material scrap etc. is put in the waste-bins provided in the laboratories which are emptied by the house keeping person at least once a day.

  • Food & Drinks for human consumption are not stored in lab.
  • Smoking or chewing of tobacco is not allow in factory premise.
  • Never use broken or deforming glassware in laboratory.

On completion of analysis, all the glassware used are removed from the working table by QC analyst and kept in the washing area to be cleaned and washed by the laboratory Attendant.

On completion of a day’s work the analyst ensure that all gas connections, air inlets, electrical connections, water taps are put off.

The inflammable and poisonous chemicals should be stored under lock and the control should be with authorized person only.

  • Fire Extinguishers should be provided at various location in the lab area.
  • During the usages of Hazardous Chemical wear safety goggles, gloves and nose mask.
  • Always wear laboratory coats and safety glasses, protective gloves whenever necessary.
  • No unauthorized experiments shall be done in the laboratory.
  • Never taste a chemical for identification. Smell chemicals only when necessary and do it by fanning the vapour towards the nose.
  • Never pour water into concentrated acid. Always pour the acid slowly into water while stirring.
  • Always flush the outside of acid bottle with water before opening. Do not put the stopper on the counter top where someone else may come in contact acid residue.
  • Where toxic or objectionable gases are to be given off during the experiment, conduct the experiment in the fume cupboard.
  • Take special care when dealing with mercury. Keep all mercury containers well stoppered. In case of an accident involving mercury, the area should be cleaned carefully until there are no globules remaining.
  • Keep chemical regents with labeled bottles. Read the label carefully before removing a reagent bottle. Do not take more chemical than required. When you finish, return the    bottle to its correct position on the shelf. Never return unused chemicals or solutions to the stock regent bottle. Label all containers before filling.
  • Never pipette any liquid by mouth. Use mechanical means such as rubber bulb or an automatic dispenser.
  • Never drink from a beaker.
  • Do not look down in to a test tube being heated or containing chemicals, and do not  point its open end at another person. (A reaction might cause the containers to be  ejected, resulting in any injury).
  • In the events of an apparatus on fire, turn off the heating source, if possible extinguish the fire by limiting the supply of oxygen to the fire and make sure there is no personal hazard.
  • Use tongs or asbestos gloves to remove all glassware from heat (hot glass can cause severe burns).
  • Ensure that no naked flame exists in the room when using low boiling point, flammable solvents, such as diethyl ether and preferably perform the experiment in a fume up board.
  • Always use a protective mask or perform the experiments under a fume hood in a well ventilated area when working with chlorine, hydrogen Sulphate, carbon monoxide,   hydrogen cyanide and other very toxic substance.
  • While working with volatile materials, remember that heat causes expansion and confinement of expansion results in explosion. Also remember that danger exist even though external heat is not applied.
  • Do not use Perchloric acid around wooden benches or tables. When using perchloric acid always wear protective clothing. (Perchloric acid is dangerous because it explodes    on contact with organic materials).
  • When hazardous materials are being used for example, highly toxic solutions or gases or highly flammable materials, follow the safety precaution given the working methods    carefully. If there is any doubt about the procedure, consult the manager QC.
  • Splattering from acids, caustic materials and strong oxidizing solutions on the skin or clothing should be washed off immediately with large quantities of water.
  • When there is a chemical splash created by alkali metals and phosphorus, clean the reminder of the substance from the skin first and wash continuous flow of water.
  • Do not keep solutions for a long time exposed to air. Strong some substance by exposing in the air for a long period of time like solutions of complex salts (ammonium, lead) and ethers can result in explosion.
  • Do not keep ammonium close to halogens, because if they interact they give exploding substance.
  • Salts of chlorine, bromine and iodine are very dangerous to keep close to easily oxidizing liquids like alcohols, because if they interact with each other they can give exploding mixture’s using hot plates and other electrical equipment’s, ensure the wire and plug are in good condition.
  • Never handle electrical connection with damp hands.
  • Ensure nobody should be in QC lab before closing of lab at evening.

Laboratory chemicals, regents, solution & Glassware’s:

Maintain a minimum level for chemicals and regents in the store.

An indent is placed by QC personnel with the purchase / stores department & on arrival of material in stores, material is verified by QC personnel for contents & quantity.

The material is issued on requisition and the quantities are recorded in stock register in respective labs, as per usages.

Check glassware for physical deformity.

All volumetric, test & indicator solutions required for analysis in the laboratory are prepared by QC Personnel/Analyst as per the respective SOP. Volumetric solutions are standardized by QC Personnel/Analyst for the exact concentration of the solution as per the SOP standard analytical procedure.

Indicator solutions are prepared by QC Personnel/Analyst as per the method detailed in the concerned pharmacopeia and standard Analytical Procedure. Prepare solutions in purified water.

All prepared solutions are stored in appropriate stoppered glass bottles of varying sizes a labeled by QC Personnel/Analyst on all bottles.

A record shall be maintained for the preparation of primary standards for the standardization of volumetric solution.

Position of the bottles containing solutions in an orderly manner on the racks meant for the purpose. Any solution bottle if removed for use shall be replaced back by QC personnel/Analyst after completion of work.

Verify all volumetric Glassware’s received in the laboratory for for their volume by the QC Personnel/Analyst & in the event of non-conformance, the glassware should be rejected. The certificates for the A-class Glassware’s provided by the manufacturer are maintained.

  • Use only AR/GR grade chemical for standardization.
  • Use clean and dry glassware for dilution use.
  • Always use such pipette whose tips are not broken.

Operation & Calibration of laboratory instrument:

  • Maintain room having sophisticated laboratory instruments at the temperature ranging. NMT 27ºC and the records are maintained.
  • All laboratory instrument carry a slip depicting the instrument no. Calibration done on, calibration due on and done by.
  • The instruments used in the laboratory are provided with the SOP’s. Calibration checks are performed by QC Personnel at assigned intervals as per procedure and are recorded in respective calibration format meant for that instrument.
  • Calibration of Grade A glassware not required. The certificates for the A-class Glassware’s provided by the manufacturer are maintained.
  • If continuation sheet required for data record or calculation then Analysis Work sheet (Attachment-l) shall be used. Analysis Work sheet also used for Analysis of Non routine, Miscellaneous and vendor sample or wherever worksheet is not available.
  • Affix the analysis status label on each instrument it should be maintain by analyst at the time of activity.
  • Calibration shall be perform as per respective SOP, and maintain the calibration calendar.

Sampling & Testing:

  • Sample, test and release raw materials as per respective procedure.
  • Receipt, testing & release of packing materials are performed as per the respective procedures.
  • Testing & release of in process samples is dine as per respective procedure.
  • The testing and release of finished samples is done as per respective procedure.
  • The test data with regarding and calculations of all raw & packaging materials is duly signed with date and is recorded in a worksheet or analytical protocol.
  • Any documents related to analysis or procedure (i.e. chromatograms, Test Data Sheet, calculation sheet etc.) have invalid or extra generated due to any reason. It should not be torn and its should be attached with original data after invalid stamp with comment.
  • During analysis if found any discrepancy, analyst shall inform immediately to Head QC/In-charge QC. It shall be handle as per respective procedure.
  • If any discrepancy observed, same shall be investigated as per respective SOP. After completion of investigation initial invalid data shall be invalidated to putted  INVALID DATA stamp.

 Reference Standards and Working Standard

  • Reference standards are procedure and maintained as per respective procedure.
  • If any reference or working standard has 2-8 °C storage condition then before use it should be attain room temperature.

 Proper Entry & Labelling

  • During the analysis Analyst /Personnel shall be enter proper details in respective log Book/Registers.
  • During the analysis Analyst shall write the proper details (Product Name, B. No. & Test) on the glassware which use in analysis.
  • Update the Analysis status on label which was affixed on instrument as per attachment-II

Data recording and review

  • After review of analytical data report shall be release in SAP system.
  • Data shall be recorded online during analysis as per respective analytical work sheet.
  • Any cutting shall be handled as per GDP sop or QMS tool.
Also read – GLP-GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS

Reference – Revised schedule- M (28th December, 2023)