| Receiving, Storage and usage of reference standard/primary/analytical standards |
1.0 OBJECTIVE To lay down a procedure for describe the steps to be followed during procurement and handling of standard/primary/analytical standards 2.0 SCOPE This SOP is applicable for describe the steps to be followed during procurement and handling of reference standard/primary/analytical standards in Quality Control Department. 3.0 RESPONSIBILITY QC – Officer/ Sr. Officer /Executive/Sr. Executive and above. 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Definitions: 5.1.1 Primary Standard: Primary standards are reagents that are extremely pure, stable, and have no waters of hydration. They are established by organizations such as the National Institute of Standards and Technology (NIST) in the United States, National Physical Laboratory (NPL) in the United Kingdom etc. Primary standards that are used for the standardization and re-standardization of volumetric solutions are also known as volumetric standards in quality control lab. Alternatively, substances or chemicals procured along with the certificate of analysis from the authorized manufacturers to be used in the standardization of volumetric solutions. 5.1.2 Reference Standard: These are authentic substances of high purity with critical characteristics and suitable for their intended purposes. These are supplied by the official pharmacopoeia agencies. (e.g. drug substances, excipients, impurities) 5.1.3 Analytical Standard: Reference materials, which are procured from reputed manufacturers or supplied by the approved vendors and R&D / PDL. (E.g. internal standards.) 5.2 Receipt of standard/primary/analytical standards: 5.2.1 The reference/primary/analytical standard shall be procured from authorized agents or manufacturers only. 5.2.2 Ensure to procure the correct lot of reference/primary /analytical standard. 5.2.3 On receipt of reference/ primary/analytical standard ensure that the supplied reference/primary and analytical standard is of current lot with the catalogue; if the supplied reference/primary and analytical standard is not of current lot then return the same to the supplier or manufacturer. 5.2.4 After receipt of reference/primary and analytical standard the details shall be recorded in the format XXX “Reference/primary and Analytical standard receipt log” and allot a unique number as below: For Reference Standard E.g. QC/RS/001/XX QC : Quality Control RS : Reference Standard 001 : Continuous serial number starting from 001 XX : Last two digit of Standard receipt year. For example: QC/RS/001/23. 5.2.5 Prepare the Reference standard label and stick properly to a respective vial (as mentioned in Format No.: XXX). For Primary Standard E.g. QC/PS/001/XX QC : Quality Control PS : Primary Standard 001 : Continuous serial number starting from 001 XX : Last two digit of Standard receipt year. For example: QC/PS/001/23. 5.2.6 Prepare the Primary standard label and stick properly to a respective vial (as mentioned in Format No.: XXX. For Analytical Standard E.g. QC/AS/001/XX QC : Quality Control AS :Analytical Standard 001 : Continuous serial number starting from 001 XX : Last two digit of Standard receipt year. For example: QC/AS/001/23. 5.2.7 Prepare the Reference standard label and stick properly to a respective vial (as mentioned in Format No.: XXX. 5.2.8 When usage of reference/primary and analytical standard the details shall be recorded in the format XXX “Reference/primary and Analytical standard usage log”. 5.2.9 File the documents received like certificate, MSDS etc., in the reference/primary and analytical standard document file. 5.3 Storage of reference/primary and analytical standards: 5.3.1 Store the reference/primary and analytical standard in the original stopper containers, with special precaution taken if specified on the label. 5.3.2 Use the reference/primary and analytical standard up to validity period recommended by the manufacturer or as indicated in the catalogue of official reference standards. 5.3.3 Use only current lot of reference/primary/analytical standard and check the current lot of reference standards with reference standard catalogue monthly. 5.3.4 After removal of reference/primary/analytical standard for use from the storage place, keep aside for attaining the room temperature, if required. 5.3.5 Do not transfer back the withdrawn quantity of reference/primary and analytical standard into its original container. 5.3.6 The analyst should keep the reference/primary and analytical standard out of storage for as short period as possible to prevent light and moisture affecting the standard. 5.3.7 After usage of reference/primary and analytical standard return it back to the appropriate storage location immediately. 5.3.8 Use the reference/primary and analytical standard only for the purpose, for which it is recommended. 5.3.9 Prepared impurity solution can be used till the system suitability passes unless otherwise used in quantification. |
