This comprehensive overview provides an in-depth look at the importance of good laboratory practice in the pharmaceutical industry and outlines the steps necessary to ensure successful laboratory operations.
DISTRIBUTION:
1.0 Purpose:
1.1 To lay down a procedure for Good Laboratory Practice.
2.0 Scope
2.1 This SOP shall apply to Good Laboratory Practice at (Company Name & location)
3.0 Responsibilities:
3.1 QC Executive/ Designee: To understand the procedure and to apply it in practice.
3.2 QC-Head/Designee: To review the SOP and its implementation.
3.3 QA-Head/ Designee: To approve the SOP and ensure its implementation.
4.0 Material and Equipment:
None
5.0 Procedure
5.1.1 Always follow respective standard operating procedures while performing any analysis.
5.1.2 Always use pure (AR/GR) material for standardization.
5.1.3 Always use calibrated volumetric glassware for accurate dilutions.
5.1.4 Room temperature i.e. 25°C during dilution, at the time of volumetric measurement and standardization.
5.1.5 Rinse the burette or other vessels used to collect the volumetric solution with the solution to be standardized.
5.1.6 Handle the chemicals and solvent carefully to avoid spillage of the chemicals on the working bench and the floor.
5.1.7 Immediately clean the affected area according to the type of spillage in case of any spillage.
5.1.8 Always add concentrated acid slowly to water while diluting and never add water to the acid.
5.1.9 Always wear full-seal goggles and a safety mask while handling concentrated acids and bases.
5.1.10 Always use a beaker or wide container while adjusting the pH of any solution. A narrow-neck container should not be used.
5.1.11 Never stick a spatula into a container never return the unused reagent. Roll the container to deliver the reagent to the receiving beaker.
5.1.12 While weighing the reagent never return the unused reagent to the reagent container, may cause contamination of the whole reagent supply which will be more costly than the small amount of reagent discarded.
5.1.13 Always use distilled water for the preparation and standardization of solution, preparation of buffer solution, indicator solution, and standard solution unless otherwise specified.
5.1.14 Standardize the volumetric solution with the method that is used for endpoint determination.
5.1.15 Light resistant container i.e. (Amber colored) should be used for light-sensitive solution.
5.1.16 Properly label all the reagents for name, strength, prepared by, and prepared date and shelf life.
5.1.17 During titration of colorless solutions in the burette, always consider the lower meniscus as the reading and in the case of colored solution always consider the upper meniscus as the reading.
5.1.18 During titration, always fill the burette taking it into hand from the stand using a glass funnel, and adjust the reading to zero before starting titration.
5.1.19 Approximately 0.1 ml of indicator, during titration or standardization, unless otherwise specified.
5.1.20 In case of iodometric titration use an iodine flask use broken glassware
5.1.21 Use a separate area under lock and key to store toxic and flammable chemicals.
5.1.22 Specified areas should be used to store reference standards and working standards.
5.1.23 Sealed the bottle of working standard immediately and stored it in the provided desiccator after using the working standard.
5.1.24 Never leave any chemical reaction taking place on the gas i.e. boiling, distillation, reflux condenser unattended.
5.1.25 Keep the container open while boiling anything, if not refluxing.
5.1.26 Check the LPG connection valve for any damage and if found repair it immediately.
5.1.27 Always close the valve first and then put off the compressor while working with them, if the compressor is closed first there might be a chance of an explosion.
5.1.28 While mopping the LAF bench, always keep the burner off.
5.1.29 Put on the UV light after completion of microbiological work.
5.1.30 Never look directly into the UV light.
5.1.31 Always use a calibrated instrument for analysis.
5.1.32 Consult QC manager/ Executive head to get repaired or changed if any instrument/ equipment is found damaged.
5.1.33 Always use distilled water to wipe off the pH meter or conductivity meter electrode with the help of tissue paper.
5.1.34 Never rub the electrode and keep all the electrodes dipped in distilled water.
6.0 Abbreviations:
6.2 QC: Quality Control
6.3 QA: Quality Assurance
6.4 NA: Not Applicable
6.5 LPG: Liquid Petroleum Reagent
6.6 AR: Analytical Grade Reagent
6.7 GR: General Reagent
6.8 UV: Ultra Violet
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