SOP on Handling of Primary Standard

• 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

                                                             Annexure – I

                                              List of Primary Standard 

                                                            Annnexure – II

                                      Consumption record of Primary Standard 

Pharma More Jobs and post Please click here