STANDARD OPERATING PROCEDURE FOR PREPARATION AND HANDLING OF WORKING STANDARD

1.0 OBJECTIVE

1.1 To lay down a standard procedure for preparation, storage, and use of Working Standards in an Animal House Facility

2.0 SCOPE

2.1 This SOP shall be applicable to all working standards which are used as a reference standard in analysis in Animal House Facility (AHF).

3.0 RESPONSIBILITY

3.1 Head- QA

3.2 QA Personnel (QAP)

3.3 Head- AHF

3.4 All Personnel involved in the handling of Reference Standards and preparation and handling of Working Standards

4.0 DEFINITIONS

4.1 Nil

5.0 PROCEDURE

5.1 Handling of Reference Standards

5.1.1 Reference Standards shall be procured from approved vendors.

5.1.2 After receiving the reference standards, enter the details of reference standards in a format no. F………………...

5.2 Preparation and Handling of Working Standard

5.2.1 Working Standards shall be procured from approved vendors. Working Standards shall always be standardized against Reference Standards. If Reference Standards are not available, Working Standard shall be standardized against the previously standardized working standard.

5.2.2 Perform the recommended assay in triplicate.

5.2.3 The average of three results shall be used to determine the assay value. The RSD of 3 assay values shall not be more than 1.0 %.

5.2.4 Record the analysis details in the working sheet for Working Standard (Format No. F......................).

5.2.5 Record the details of the Working Standard in format No.: F...................................

5.2.6 The label of Working Standard shall contain the following details:

5.2.6.1 Working Standard Number

5.2.6.2 Name of Working Standard

5.2.6.3 Assay

5.2.6.4 Prepared on

5.2.6.5 Use before

5.2.6.6 Prepared by

5.2.6.7 Opened on

5.2.7 On the opening of the bottle, the Analyst shall mention the date of opening the bottle.

5.2.8 The Working Standard shall be used within one year from the date of Standardization or within the time specified depending upon the stability /nature of the Reference Standard.

5.2.9 The new Working Standards shall be prepared before the expiry of the existing Working Standard.

5.3 Storage and Consumption

5.3.1 The Working Standard bottle, which is in use, shall be stored in desiccators with silica gel at the indicated temperature. Store the remaining bottle of Working Standard and Reference Standards in the refrigerator at 2-8° C or the temperature indicated.

5.3.2 The vials remaining after one year shall be destroyed as per the procedure accepted for disposal of test items.

5.3.3 Refrigerated vials should be brought to room temperature before use.

5.3.4 The consumption record of the Reference Standard and Working Standard shall be maintained in format No. F……………. and format No. F……………… respectively.

5.4 Numbering system For Working Standard

5.4.1 All Working Standards shall be numbered as per a unique numbering system of 14 characters as below:

XXX/YYY/ZZ/001

Where first three characters are ‘XXX’ which signifies working standard name code (A……), 5th, 6th and 7th characters are ‘YYY’ which signifies ‘Department Code’ to which Working Standards belongs i.e. DQA for Quality Assurance, AHF for Animal House Facility 9th and 10th characters are ‘ZZ’ which signify the last two digits of the year in which working standard prepared; The 12th,13th and 14th characters are ‘001’ signify the Sr. No. of working standard; Character No. 4th, 8th, and 11th characters are oblique mark ‘/’.

5.4.2 For example: First …….. Working Standard prepared in 2015 from Reference Standard shall be given numbering as …………...

6.0 ENCLOSURES

6.1 Annexures

Sr. No.	Annexure Title	Annexure No.	No. of pages
1.	Working standard name code	A………………….	01

6.2 Formats

Sr. No.	Format Title	Format No.	No. of pages
	Record of Reference Standard Details	F……………………..	01
	Record of Working Standard Details	F……………………..	01
	Consumption Record for Reference Standard	F…………………….	01
	Consumption Record for Working Standard	F…………………….	01
	Working sheet for working standard	F…………………….	01
	Label for working/reference standard	F…………………….	01

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

7.3 AHF- Animal House Facility

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1 Nil

END OF DOCUMENT

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