1.0 OBJECTIVE
To lay down a standard procedure for procurements, receipt and storage of Primary Standard.
2.0 SCOPE
This procedure applies to all primary standards used for the standardization of the volumetric solutions and In-House Instrument Calibration in the (Name of Company)
3.0 RESPONSIBILITY
Officers / Executive – Quality Control shall be responsible for complies of this SOP
4.0 ACCOUNTABILITY
Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS
Format for label for primary standards Attachment-I
Format for list of primary standards Attachment-II
6.0 PROCEDURE
6.1 Commercially available AR/GR/Spectroscopy grade materials shall be procured and used for preparation of the primary standards.
6.2 Indent shall have AR/GR/Spectroscopy grade mentioned specifically for primary standards.
6.3 On receipt of Primary Standards, seven digits Reference Code No. is allotted to each primary standard received as per the example given below update the Primary Standards List.
Example : PS-001/11 where first two letter stands for primary standards followed by (-) than 001 represent first primary standard received followed by “ / ” and 4 standards for the current year.
6.4 Take a clean and previously dried, sufficient number of narrow mouth and amber color screw capped vials for keep primary standards in it. All the primary standards shall be treated as specified in the respective pharmacopoeia before storing it into the vials.
6.5 Each vial shall be labeled as per Format- SOP/QC/010/FT01-00.
6.6 Store the Primary Standards in desiccators unless otherwise mentioned on the label of the container.
6.7 If any specific storage conditions are mentioned on the label of the bottle, store the Primary Standards appropriately.
6.8 Label the desiccators containing Primary Standards, as “Primary Standards” and keep the updated Primary Standards List nearby.
6.9 Use the Primary Standards as per the “Directions of Use” mentioned on the label of the bottle. (e.g. Dry before use at 105°C for 4 Hr.)
9.10 Validity: Primary standards shall be valid up to two years after receipt or as per manufacturer’s specification.
7.0 REFERENCES
In-House
8.0 ABBREVIATIONS
SOP: Standard Operating Procedure.
QC: Quality Control.
°C: Degree centigrade.
AR: Analytical Reagent.
e.g.: For example.
Hr.: Hour.
GR: General Reagent.
FT:Format.
PS:Primary standard
9.0 DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
| Revision No. | Date of Revision | Reason for Revision |
LIST OF PRIMARY STANDARDS
| Sr. No. | Name of Primary Standard | Make | Grade | Mfg. LOT No. / Batch No. | Reference Code No. |
