1.0 PURPOSE
To provide a standard procedure for procuring, and handling intermediate checks certified reference materials used in the chemical testing laboratories.
2.0 SCOPE
2.1 This SOP applies to all personnel involved in the quantification of residues & metals in food and related products, using the Certified Reference Material.
3.0 RESPONSIBILITY
3.1 Chemist authorized for procuring, handling, and maintenance and intermediate checks certified reference material.
5.0 DISTRIBUTION
5.1 The Quality Assurance department is responsible to keep SOP ‘Master Copy’ approved through the Quality Manager.
5.2 The copy of the ‘Control Copy’ of SOP is being distributed in all user departments and placed near related Equipment/Instruments as a ‘Display Copy ’ if required.
6.0 DEFINITION (S) & ABBREVIATION(S)
6.1 Definitions
6.1.1 Certified Reference Materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. Certified reference material is a particular form of measurement standard..
6.2 Abbreviations
6.2.1 SOP: Standard Operating Procedure
6.2.2 CRM: Certified Reference Material
6.2.3 COA: Certificate Of Analysis
6.2.4 RPD: Relative Percent Difference
6.2.5 ID: Identification
6.2.6 R: Response
6.2.7 WS: Working Standards
6.2.8 NIST: National Institute of Standard & Technology
7.0 PROCEDURE
7.1 Procurement of certified reference materials
7.1.1 Certified reference materials are obtained from the approved manufacturers/suppliers. It is ensured that the procurement of certified reference materials from all sources meets the following minimum requirements.
7.1.2 A current and valid “ Certificate of Analysis” is available, with traceability, and a current expiration date. Wherever possible the NIST traceability is ensured while procuring the CRMs.
7.2 Receipt of certified reference materials
7.2.1 As soon as certified reference material is received in the laboratory. Each standard shall be given a code that shall uniquely identify the standard from neat standard to final dilutions. Receipt of the standard shall be documented and each standard is traceable. Records shall include name, unique code purity, lot number, Quantity received gross weight, date received, and expiration date.
7.3 Storage of certified reference materials
7.3.1 Certified reference materials are stored at the recommended temperature as mentioned in the Certificate of analysis.
7.3.2 Stock standards and dilutions including mixed standards are kept in refrigerators or freezers separately to avoid any contamination.
7.3.3 Access to the freezers and refrigerators is controlled and standard usage is documented through the appropriate records.
7.3.4 Refrigerator and freezer temperatures should be checked for temperatures by taking readings once a day and records are maintained for the same.
7.4 Preparation of Stock Standard Solutions.
7.4.1 Stock standards should be prepared in a separate area to avoid contamination of samples with the standard being prepared. Each stock is identified by a label with a unique code, name, concentration, date of preparation, solvent, initials of preparer, and expiration date of the solution.
7.4.2 Records should be maintained with regard to the details of stock preparation, which includes the amount of standard used, volume made up with solvent, the solvent used, lot no of used, purity of standard, the final concentration of stock solution obtained, and location of storage.
7.4.3 The stock solution of CRMs should be stored for a maximum period of 12 months or till it is consumed- whichever is earlier.
7.5 Preparation of Intermediate Dilutions
7.5.1 Intermediate dilutions, including mixed standards should be prepared away from the area. Each standard dilution should be given a unique identification code, and label which specifies the name, concentration, solvent, date of preparation, initials of preparer, and expiration details of solutions.
7.5.2 Data pertaining to the amount of stock standard solution used, the solvent used, made-up volume, date of preparation, final concentration obtained, and expiration date should be maintained.
7.6 Standard Intermediate Checking
7.6.1 To ensure the integrity of intermediate dilutions, checks should be carried out as detailed below:
7.6.2 The working standards (WS 1 ) and (WS 2) of the same concentration should be prepared from the stock solutions as well as intermediate dilutions, and subjected to the relevant equipment the responses R1 and R2 due to WS1 and WS2 respectively should be obtained.
7.6.3 RPD % should be calculated as follows :
Relative percent difference (RPD) = [{R1- R2}/[{R1+R2}/2]] X 100
NOTE : In case R2 is greater than R1, then formulae will be :-
RPD% = {R2- R1}/[{R1+R2}/2]] X 100
Acceptance Criteria : RPD( Relative percent difference NMT 10%
Documentation of the standard intermediate checking is maintained in logbooks.
7.7 Expired Standard Verification
7.7.1 Recertification of the expired standard should be done as follows to verify its integrity.
7.7.2 Responses of expired standard, when compared with the new standard, will be subjected to RPD%. The expired standard will be considered fit for the purpose if RPD% is less than 10%. Relevant data should be recorded in the log books along with chromatographs.
7.7.3 If the two standard’s response factors are not within 10 percent, the expired standard used will be considered as not fit for purpose and this data will be recorded in the laboratory’s record.
7.8 Working Dilutions / Mixed Standards
7.8.1 Mixed standards should be prepared in a separate area to avoid any possibility of cross contamination. The label includes pesticide Mis standard code-related information maintained in the logbook. The label also includes a solvent, date of preparation, expiration date, initials of preparer, and concentration of each standard in the log book.
8.0 PRECAUTIONS
8.1.1 Not Applicable
9.0 REFERENCE(S) & FORMATS
9.1 References
9.1.1 In-house
9.2 Formats
9.2.1 Format-I: Format for Document History Sheet
10.0 REVISION HISTORY
10.1 Maintain the history of SOP or document as per the format. It shall be provided along with the current version of the SOP.
END OF THE DOCUMENT
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3. List of All SOPs and Documents For Quality Assurance Dept.
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