SOP for Good Laboratory Practice in Pharmaceutical Industry

1.0 Purpose:

To lay down a procedure for Good Laboratory Practice.

2.0 Scope:

This SOP shall apply to Good Laboratory Practice at (Company name and address).
Responsibilities:
  • QC Executive/ Designee: To understand and apply the procedure in practice. 
  • QC-Head/Designee: To review implementation.
  • QA-Head/Desigpee: To approve the SOP
sop-for-good-laboratory-practice

3.0 Good Laboratory Practice:

3.1 Procedure:

3.1.1 Always follow respective standard operating procedures while performing any analysis.
3.1.2 Always use pure(AR/GR)  material for standardization.
3.1.3 Always use calibrated volumetric glassware for accurate dilutions.
3.1.4 Room temperature, i.e., 25°C At the time of dilution, volumetric measurement, and standardization.
3.1.5 Rinse or standardize the burette or other vessels with the solution used to collect the volumetric solution.
3.1.6 HandJethechemicalsandsolvent carefully to avoid pillage of the
chemicals on the working bench/and the floor.
3.1.7 Frequently clean the affected area according to the type of spillage in case of any spillage.
3.1.8 Always slowly add concentrated acid to the water while diluting, and never add water.
3.1.9 Always wear full-seal goggles and a safety mask while handling concentrated acids and bases. '
3.1.10 Always use a beaker or wide container while adjusting the pH of the solution. The analyst should not use a narrow-neck container.
3.1.11 Never stick a spatula into a container of solid reagent. Roll the container to deliver the reagent to the receiving beaker.
3.1.12 While weighing the reagent, never return the unused reagent to the reagent container, as it may cause contamination of the whole reagent supply, which will be more costly than the small amount of reagent discarded.
3.1.13 Always use distilled water for the preparation and standardization of solution, preparation of buffer solution, indicator solution, and standard solution unless otherwise specified.
3.1.14 Standardize the volumetric solution with the method used for endpoint determination.
3.1.15 The analyst should use a light-resistant container, i.e.(amber-colored) for the light-sensitive solutions.
3.1.16 Properly label all the reagents for name, strength, preparation by, prepared date, and shelf life.
3.1.17 During titration of colorless solutions in the burette, always consider a lower meniscus as the reading. In the case of a colored solution, always consider the upper meniscus as the reading.
3.1.18 During titration, always fill the burette, taking it to hand from the stand using a glass funnel, and adjust the reading to zero before starting titration.
3.1.19 Approximately 0.1ml of an indicator during titration or standardization unless otherwise specified.
3.1.20 In the case of iodometric titration, use an iodine flask. Use broken glassware
3.1.21 Use the separate area under lock and key to store toxic and flammable chemicals.
3.1.22 The analyst should use specified areas to store references and working standards.
3.1.23 Seal the bottle of working standard immediately and store it in the provided desiccator after using the working standard.
3.1.24 Never leave any chemical reaction on the gas, i.e., boiling, distillation, reflux condenser, unattended.
3.1.25 Keep the container open while boiling anything, if not refluxing.
3.1.26 Check the LPG connection valve for any damage and, if found, repair it immediately.
3.1.27 Always close the valve first and then put off the compressor while working with them; if the compressor is closed first, there might be chances of an explosion.
3.1.28 While mopping the LAF bench, always keep the burner off.
3.1.29 Put on the UV light after completion of microbiological work. Never look directly into the UV light.
3.1.30 Always use a calibrated instrument for analysis.
3.1.31 Consult the QC Manager/Executive head to get repaired or changed if any instrument/equipment is damaged.
3.1.32 Always use distilled water to wipe off the pH meter or conductivity meter electrode with the help of tissue paper.
3.1.33 Never rub the electrode, and keep all the electrodes dipped in distilled water.

4.0 Abbreviation:

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
NA: Not Applicable
LPG: Liquid petroleum Gas
AR: Analytical Grade Reagent
GR: General Reagent
UV: Ultra Violet


0/Post a Comment/Comments