SOP for Good Laboratory Practices (GLP)
Learn how to write a (Standard Operating Procedure) SOP for Good Laboratory Practices (GLP) to ensure compliance and maintain quality in laboratory environments.
1. PURPOSE
To outlines the practices and guidelines to be followed to ensure Good Laboratory Practice (GLP) is implemented and maintained.
2. SCOPE
This SOP is applicable to all laboratory personnel for research, testing, and analysis conducted within the laboratory setting.
3. RESPONSIBILITIES
3.1 QC Executive/Officer/Analyst: Responsible to perform all laboratory activities following the steps in this SOP.
3.2 Quality Control (QC) Manager: To ensure compliance with all laboratory activities and to approve results for accuracy.
4. ACCOUNTABILITY
Head of the Quality Control Department
5. ASSOCIATED DOCUMENTS / REFERENCES
5.1 21 CFR Part 58 – Good Laboratory Practices for Nonclinical Laboratory Studies (FDA)
5.2 ICH E6 Good Clinical Practice Guidelines
6. PRECAUTIONS
6.1 Handle all chemicals, including solvents, in accordance with Material Safety Data Sheets (MSDS).
6.2 Dispose of samples and solvents in accordance with laboratory safety protocols.
7. PROCEDURE
7.1 All laboratory studies and experiments must be planned, conducted, and documented in accordance with GLP principles.
7.2 Adequate resources, including trained personnel, equipment, and materials, must be available for the successful execution of studies.
7.3 A study protocol must be prepared and approved prior to the initiation of any experiment, outlining the objectives, methodology, and evaluation criteria.
7.4 All raw data, study protocols, and reports must be accurately recorded, maintained, and archived.
7.5 All records must be legible, dated, and signed by the responsible personnel.
7.6 Any changes to records must be documented with clear reasons for the changes (e.g., corrections, additions).
7.7 Always conform to the applicable standard operating procedure while doing any analysis.
7.8 For uniformity, only use pure (AR/GR grade) materials.
7.9 When precise dilutions are needed, only use calibrated volumetric glassware.
7.10 Make that the temperature is kept at around 25°C±2°C during dilution, volumetric measurement, and standardization.
7.11 Use the solution to be standardized to rinse the burette or other container that was used to collect the volumetric solution.
7.12 Never mix water with acid while diluting; instead, add concentrated acid to the water gradually.
7.13 Take care when handling the chemicals and solvents to prevent spills on the floor and work bench.
7.14 Cleaning the impacted area right away, depending on the type of spill, is important.
7.15 Unused reagent should never be put back in its container. The tiny amount of reagent that is thrown away is less expensive than contaminating the entire supply.
7.16 Unless otherwise noted, prepare and standardize the solution by injecting it with water.
7.17 Unless otherwise indicated, use water for injection for making buffer, indicator, or standard solutions.
7.18 Standardize the volumetric solution using solely the endpoint determination technique.
7.19 When working with concentrated acids and bases, put on a safety mask and full-seal goggles.
7.20 A solution’s pH should never be changed in a narrow-neck container. Use a beaker at all times.
7.21 Do not insert a spatula into a jar of solid reagents. Roll the container every time to assure that the reagent is transferred to the receiving beaker in a regulated practice.
7.22 Keep all of the working standards and reference standards in the designated area.
7.23 In-use working standards must be kept in the designated desiccator. Additionally, the bottles are sealed right away after usage.
7.24 A chemical reaction on the gas, such as refluxing, distillation, or boiling, should never be left unchecked. 7.25 The light-sensitive solution should only be kept in the amber-colored, light-resistant containers.
7.26 Label each reagent with its name, strength, preparation date and time, and shelf life.
7.27 In the event of colorless solutions in the burette, use the lower meniscus as the reading when doing titration. Think about the upper meniscus while dealing with colored liquids.
7.28 Always use a glass funnel to fill the burette after removing it from the stand and placing it in your hand. Before beginning the titration, set the reading to zero.
7.29 Unless otherwise noted, use around 0.1 ml of indicator during titration or standardization.
7.30 Never use damaged glassware, and use an iodine flask for iodometric titration.
7.31 Keep combustible and dangerous substances locked up in a separate location.
7.32 If the container isn’t refluxing, keep it open when heat anything.
7.33 Examine the LPG cylinder and pressure tubing for any leaks or damage, and replace the tubing if necessary.
7.34 When working with them, always shut off the compressor after closing the LPG valve, as doing so increases the risk of an explosion.
7.35 When cleaning the LAF bench, always keep the burner off and put on the UV light after doing any microbiological job.
7.36 Always avoid looking any object directly at UV light.
7.37 Always utilize calibrated tools for analysis.
7.38 If an instrument or piece of equipment is discovered to be damaged, do not use it and ask the manager or executive to get it fixed or replaced.
7.39 Cleaning any electrode on a conductivity or pH meter should be done with water for injection and then carefully wiped off with tissue paper.
7.40 Keep all of the electrodes continuously dipped in the injection water and avoid rubbing them.
7.41 Laboratory operations must comply with health and safety regulations to protect personnel, test systems, and the environment.
7.42 Proper waste disposal procedures must be followed, and environmental controls must be in place to prevent contamination or hazardous exposure.
7.43 Personal protective equipment (PPE) must be used as appropriate, and safety protocols must be strictly followed.
7.44 Regular internal and external audits of laboratory practices must be conducted to ensure compliance with GLP principles.
7.45 Any deviations from GLP must be documented and corrective actions taken to resolve the issue and prevent recurrence.
7.46 Laboratory personnel must cooperate with inspections by regulatory agencies and external auditors.
7.47 Non-compliance with GLP principles will be taken seriously and may result in corrective actions, including re-training, reassignment of duties, or disciplinary measures as appropriate.
7.48 All incidents of non-compliance must be documented, investigated, and reported.
7.49 If the deviation is out of range, report it to the engineering department. Affix “UNDER MAINTANANCE” label to prevent further use until fault is rectified.
7.50If deviations from GLP are identified, a corrective action plan must be developed and implemented. The QA unit should verify the effectiveness of corrective actions taken.
8. ABBREVIATIONS / DEFINITIONS
8.1 Good Laboratory Practice (GLP): A system of management controls for research and testing to ensure the consistency, reliability, and quality of data and results.
8.2 Laboratory: Any facility where experiments, tests, or research activities are performed.
8.3 SOP: Standard Operating Procedure
8.4 QC: Quality Control
8.5 PPE: Personal Protective Equipment
8.6 LPG: Liquefied Petroleum Gas
8.7 UV: Ultraviolet
8.8 LAF: Laminar Air Flow
8.9 AR grade: Analytical Reagent Grade
8.10 GR grade: Guaranteed Reagent Grade
8.11 GLP : Good Laboratory Practice
9. ANNEXES
N/A
10. Revision History
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |
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