- 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
- 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
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
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Quality Control
Reason for Revision
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|
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube