Primary and Secondary Standards Handling SOP

Standard Operating Procedure (SOP) for Handling of Primary and Secondary Standards used in Quality Control Laboratory for Analytical Purpose.

Handling Procedure for Primary and Secondary Standards

1.0   PURPOSE :

    • The purpose of this SOP is to define the procedure for handling of primary and secondary standards used in analysis.

2.0   SCOPE :

    • This procedure is applicable to all primary and secondary standards, which are used for the preparation and standardization of volumetric solution in quality control Laboratory.

3.0   RESPONSIBILITY:

    • QC Analyst shall be responsible for handling, usage and discardation of  the primary and secondary standards as per the SOP and to maintain proper documentation as per the defined procedure.
    • QC Head shall be responsible to provide training to all the concerned persons in QC and to ensure that the system is followed as per the SOP.
    • QA shall be responsible to review the SOP and to ensure the implementation of the system as per the SOP.
    • Plant Head and Quality Head shall be responsible for approval of the SOP.

 4.0   ABBREVIATIONS:

    • COA : Certificate of analysis.Primary and Secondary Standards
    • QC : Quality Control
    • QA   : Quality Assurance
    • SDS : Safety Data Sheet
    • SOP    : Standard Operating Procedure
    • DEFINITION:
    • Primary standard: Standard which is used for standardization.
    • Advertisement
    • Secondary standard: Standard which is used for preparation of volumetric solutions.

5.0   PROCEDURE FOR HANDLING OF PRIMARY AND SECONDARY STANDARDS :

    • Receipt of Primary and Secondary Standards:

    • Reagents of best available quality shall be procured for  usage as Standards.
    • Designed person shall ensure the intactness and condition of container at the time of receipt.
    • Designed person shall ensure the availability of COA at the time of receipt and put Sign and date after verifying the COA for correctness and completeness.
    • Storage of Primary and Secondary Standards:

    • Primary and Secondary standards shall be stored as per the storage conditions mentioned on the container label.
    • If the storage condition is not mentioned on the container , it shall be considered from  the manufacturer  COA or  SDS of  the reagent
    • If the storage condition is not available from any of the above sources or any other reliable source, the standards shall be stored below 25°C.
    • Label shall be affixed on the container as per label given below mentioning the storage condition of the reagent.
    • Coding and labelling of Primary and Secondary Standards :
    • Analyst or designed person from QC shall allocate the identification (code No.) to the standards.
    • Coding system for the primary standards shall be as follows.
      • Code No. = P / XX
      • Where,
      • XX = Stands for the Serial Number of primary standard.
      • P = Stands for the Primary standard
    • Coding system for the secondary standards shall be as follows.
      • Code No. = S / XX
      • Where,
      • XX = Stands for the Serial Number of secondary standard.
      • S = Stands for the Secondary standard
    • Analyst shall affix the label as given below and assign the desired code No. on the standards and mention its recommended storage condition.
          • Material Name :
          • Code No.:
          • Storage condition :
    • Use the standards as per the expiry date provided in the manufacturer COA.
    • In case the manufacturer does not mention the expiry or use before date, the expiry date shall be assigned as 3 years from the date of opening.
    • Entry in log book:

    • Analyst shall allocate the page number for respective primary and secondary standards in the usage logbook.
    • Analyst shall mention the “Name of Primary Standard” “Batch No. “Receipt Date” “Mfg. by” and “Use before date” on the top of the page and shall make entries in respective columns during usage.
    • Discardation of Standards :

    • Analyst shall destroy the excess dried standard after use. Fill it back to the same container.
    • Analyst shall destroy the standards after expiry as per the following procedure,
    • Make cross line on the bottle label.
    • Transfer the material into a bucket containing water.
    • Analyst shall stir the dispersion/ solution with the help of a glass rod and allow dispersing the material.
    • After the complete dispersion, drain the dispersion into drainage.
    • Analyst shall replace the old standard with the new standard and follow the above procedure.
    • If any change is observed in physical appearance of the standard, Inform QC Head immediately.
    • Do not use such solutions.

6.0   ANNEXURES – PRIMARY AND SECONDARY STANDARDS:

Annexure 1 : Primary and secondary standards log book.

Name of Primary Standard
Batch No.
Receipt Date
Mfg. By
Code No. Use Before:
Date Receipt Qty

(In gm)

Issue Qty.

(In gm)

Balance Qty.

(Theoretical in gm)

Used in standardization of Volumetric Solution Name Standardization Protocol/Template No. Analyst Sign/Date Remarks

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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