- Objective:To lay down a procedure for the handling of Primary Standard.
- Scope:This Standard Operating Procedure is applicable to Quality Control Department followed at Pharmaceutical Company name with location.
- Responsibility:QC personnel shall be responsible to follow the procedure as per SOP.
- Accountability:Department Head & QA Head shall be accountable for implementation of this SOP.
- Abbreviations and Definitions:
- SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
- QC: Quality Control
- COA :Certificate of Analysis
- MSDS :Material Safety Data Sheet
- Procedure:
- Chemicals which shall be used in the calibration of instrument or in the standardization of volumetric solution shall be categorized as primary standards.
- QC personnel shall keep MSDS and COA of each primary standard.
- Separate out one container of the each reagents / chemicals which are to be used as primary standard.
- Take these containers in a separate cup-board labeled as Primary Standard.
- Maintain the date of opening on primary standard at the time of opening for use and also mention use before date on the label.
- Assign Identification number for primary standards follows:PS/XX/YY
Where,
PS : Stand for Primary Standard
XX : Stand for serial number
YY : Stand for serial Year
- All opened primary standard shall be used within 2 years from the date of opening or up to expiry date (if mentioned), which ever is earlier.
- If pharmacopeial reference standards are being used for instrument calibration then these reference standards shall be handled as per SOP.
- All primary standards shall be kept in tight containers at the room temperature, unless any other storage condition is specified on the label.
- Never add remaining quantity of the transferred material back into stock bottles.
- Maintain the list of primary standard as per Annexure – I and consumption record of primary standard as per Annexure – II .
- Forms and Records (Annexures)
- List of Primary Standard – Annexure – I
- Consumption record of Primary Standard – Annnexure – II
- Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Quality Control
- History
| Date | Revision Number |
Reason for Revision |
| 12/04/05 | 00 | New SOP |
Annexure – I
List of Primary Standard
| Sr. No. | Identification Number | Name of Chemical / Reagent | To be used for |
Annnexure – II
Consumption record of Primary Standard
| Name of Primary Standard: Primary Standard ID. No.:
Batch No. / Lot No.: Make: Gross Weight / Total Volume: Date of opening: |
||||||||
| Sr. No. | Date | Opening Quantity | Quantity Used | Balance Quantity | Used For | Used By | Checked By | Remarks |
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