good laboratory practices

admin

3 hours ago

GOOD LABORATORY PRACTICES

1.0 Purpose
1.1 To describe a procedure for implementing Good Laboratory Practices (GLP) in the Quality Control Lab.

2.0 Scope
2.1 This standard operating procedure is applicable for implementing Good Laboratory Practices (GLP) in QC Laboratory at ABC Pvt. Ltd.

3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP
Assistant Manager Reviewing and Training of SOP
Manager QC Implementation of SOP

4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.

5.0 Procedure
5.1 Gowning and Work Habits
5.1.1 All Department employees shall wear an apron, cap and slippers (of designated colour) /shoe

cover in the laboratory, as per the standard gowning procedure.
5.1.2 Analysts shall work at the respective workplace and keep them neat and clean (including table and drawers).
5.1.3 Analyst shall wear safety glasses, nose masks and hand gloves, whenever required during the testing.
5.2 Quality Control Laboratory Premise
5.2.1 Quality Control Laboratory function shall be free from dust and other disturbances. Mopping of the

floor shall be done twice daily with potable grade water.
5.2.2 The premise of Quality Control department shall be well ventilated, with proper arrangements of air

conditioning. Microbiological areas have independent AHUs to avoid contamination.
5.2.3 The laboratory plan including its furniture shall be constructed in such a way to facilitate smooth working.
5.2.4 Working tables shall be smooth and resistant to most of the acids, alkalis and solvents and easily cleanable.

Floor and ceilings shall also be easily cleanable.
5.3 Instruments
5.3.1 Wherever required, instruments shall be kept in controlled temperature and humidity,

as per manufacturer recommendations.
5.3.2 All instruments shall be kept clean every time and serviced regularly as per the Annual Maintenance

Contracts and/or paid service plan with the outside agencies or from the In-house resources. A record of the

service performed on each instrument shall be maintained.
5.3.3 Instruments shall be calibrated and/or validated as per applicable SOPs. Record of calibration

and / or validation shall be maintained.
5.3.4 Standard operating procedure for each instrument shall be made available separately for its

operation and calibration.
5.3.5 All the instruments shall be switched off after use, unless required.
5.4 Glassware
5.4.1 All the glassware shall be procured from standard glassware manufacturers.
5.4.2 Glassware used for quantitative purposes shall be calibrated on the first time receipt of the glassware

and/or the frequency defined in the SOP for calibration of glassware.
5.4.3 Glassware shall be cleaned properly as per SOP after each analysis, and dried before next use.
5.4.4 The analyst shall verify the cleanliness of the glassware by visually inspection, before use.
5.4.5 After completion of analysis, glassware containing hazardous chemicals and poisonous materials shall

be emptied immediately into the sink under continuous flow of water, and then shall be kept in the washing trays.
5.5 Documentation
5.5.1 Current departmental SOPs shall be strictly followed by all employees in the laboratory.
5.5.2 Properly authorized specifications, Standard test procedure and other required work instructions

shall be available in Quality control laboratory for each analysis for each product.
5.5.3 All the materials shall be analyzed strictly as per the respective current specifications.
5.5.4 Recording of primary data shall be done in controlled protocol formats only.
5.5.5 No change in document shall be allowed unless a written authorization through proper change

control procedure is being followed.
5.5.6 After analysis all the test Protocols along with supporting raw data documents, graphs, printouts,

samples, report etc. shall be submitted to Manager Quality Control/Manager-Quality Assurance.

It shall be checked, verified and stored along with the respective document folder.
5.6 Chemicals and Reagents
5.6.1 All the chemicals shall be stored as per their properties and hazardous nature viz. inflammable,

at the designated place.
5.6.2 All the chemicals and reagents shall be labeled properly on receipt. Labels on chemicals and

reagents shall bear the standard labels.
5.6.3 All chemicals/ reference standards/ working standards shall be kept back to their respective

designated place after use and should be sealed properly.
5.6.4 Chemicals and reagents shall not be pipette through mouth. Pro-pipettes or rubber bulbs

shall be used for this purpose.
5.6.5 Chemicals and reagents taken out for analysis shall not be returned back to the mother

container. This shall be discarded.
5.6.6 Hazardous solutions shall be handled with precaution at the designated area.
5.6.7 No storage of any solutions (except stock solution with proper labels) in refrigerator or in

cupboards shall be done.
5.7 Personnel Training
5.7.1 Laboratory staff shall be adequately qualified and sufficient in number to perform the

assigned analytical work.
5.7.2 All the personnel shall undergo on-the job training in all Quality Control and Quality

Assurance functions.
5.7.3 Each new recruit shall undergo induction training and training related to the different analysis areas.
5.8 Safety
5.8.1 Proper hand gloves, goggles and nose masks shall be used during handling of volatile corrosive chemicals.
5.8.2 First aid chart shall be available in the chemical testing room. Necessary first aid box shall

be available in laboratory, with instant access.
5.8.3 All the electrical lines and gas lines shall be switched off after use.
5.8.4 Proper safety precautions, wherever specified, shall be followed during analysis.
5.8.5 Smoke alarms, fire extinguishers and water showers shall be installed/kept for safety purpose.
5.9 House keeping
5.9.1 Laboratory shall be neat and clean. The record of its cleaning shall be maintained as per SOP

on Good Housekeeping Practices.
5.9.2 Instruments, working tables and drawers shall be kept clean by the analyst.
5.10 Miscellaneous
5.10.1 Results of out of specifications (OOS) shall be immediately reported to

Manager- QC/ Manager-Quality Assurance. For any action anomaly, SOP on the OOS shall be followed.

6.0 Reference
As per Schedule L1

7.0 Attachments
Not Applicable

8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.

9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure

10.0 Revision History