SOP FOR GLP | STANDARD OPERATING PROCEDURE FOR GOOD LABORATORY PRACTICE

1.0	OBJECTIVE
1.1	To lay down a standard procedure for good laboratory practice.
2.0	SCOPE
2.1	This SOP shall be applicable to avoid the errors inherent during the performance of analysis in the Quality assurance Department (QAD) and Animal House Facility (AHF).
3.0	RESPONSIBILITY
3.1	Head- QA
3.2	QA Personnel (QAP)
3.3	Head- AHF
4.0	DEFINITIONS
4.1	Nil
5.0	PROCEDURE
5.1	All Personnel shall wear an apron in the laboratory and also safety glass, mask, and hand gloves whenever required.
5.2	Supervisors shall work at their designated workplace and should keep their workspace neat and clean (including tables and drawers).
5.3	All instruments should be cleaned and maintained properly by the respective operator of the instruments.
5.4	For analysis always use calibrated instruments.
5.5	The analyst shall make an entry in the instrument logbook daily for the analysis.
5.6	While performing any analysis always follow the respective standard operating procedure.
5.7	Use calibrated volumetric glassware only, when accurate dilution is required.
5.8	After completing analysis, all used glassware shall be emptied and kept for washing under the designed area.
5.9	Ensure that temperature during dilution, at the time of volumetric measurement, and standardization is maintained i.e. at about 25°C.
5.10	Handle the chemicals and solvents in a way to avoids spillage on the working bench and the floor.
5.11	In case of any spillage immediately clean the affected area, according to the type of spillage.
5.12	Never try and adjust the pH of a solution in a narrow-neck container, always use a beaker.
5.13	Never stick a spatula into a container of solid reagent, always roll the container to deliver the reagent in a controlled manner to the receiving beaker.
5.14	Never return unused reagents to the reagent container. Contamination of the whole reagent supply is more costly than the small amount of the reagent discarded.
5.15	Use Water for injection, unless otherwise specified, for preparation and standardization of solution.
5.16	Store the light-sensitive solution in the light-resistant (amber-colored) containers only.
5.17	Label all the reagents / biochemical kits for the Name, strength, prepared by & on, and shelf life.
5.18	Store toxic and flammable chemicals in a separate area under lock and key.
5.19	Store all the reference standards and stock of working standards in their specified area.
5.20	Working standards in use are to be stored in the desiccators provided at the specified environmental conditions. Bottles are sealed immediately after their use.
5.21	Hazardous and poisonous chemicals/solutions should be handled with precaution at the designed area.
5.22	Never look directly into the UV light.
5.23	If the instrument/equipment is found damaged, do not use it and consult an authorized person to get it repaired or changed.
5.24	Follow good documentation practices while recording any data.
5.25	Results of specification (OOS) should be immediately reported to QA/QC Manager.
6.0	ENCLOSURES
6.1	Nil
7.0	ABBREVIATIONS
7.1	SOP- Standard Operating Procedure
7.2
	GLP- Good Laboratory Practices
7.3	QAD- Quality Assurance Department
7.4	AHF- Animal House Facility
8.0	REFERENCES
8.1	In-house
9.0	REVISION HISTORY
9.1	Nil
END OF DOCUMENT 1. List of All SOPs and Documents for Good Laboratory Practice (GLP)

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