Procurement and Handling of Reference Standards – SOP

By / Quality control, SOP / QC, SOP /

SOP for Procurement and Handling of Reference Standards in Pharmaceutical Industry | Reference Standard SOP |

  • Reference Standards SOP covers below points:
    • What is Reference Standard
    • Procurement of reference standard
    • Receipt of reference standard
    • Handling of reference standard
    • Storage of reference standard
    • Discard of reference standard
    • Reference Standard Usage Register / Log format
1.0 OBJECTIVE :
  • To lay down a procedure for Procurement and Handling of Reference Standards.
2.0 SCOPE :
  • This procedure is applicable for procurement and Handling of Reference Standards.
3.0 RESPONSIBILITY :
  • Quality Control Officer and above
4.0 ACCOUNTABILITY:
  • Quality Control Head
5.0 PROCEDURE :

5.1 REFERENCE STANDARD :

  • Reference Standard is widely acknowledged to have the appropriate characteristics with high purity, within a specified content, and whose value is accepted without requiring comparison to another substance.
  • These substances are obtained from officially recognized sources.
  • Reference Standard are supplied by the official pharmacopoeia commissions. 
  • These are used as a basis of comparison for determining the purity of the test specimen. 
  • As Reference Standard  is available only in small quantities, working standards are prepared to act as substitutes after standardization at regular interval against the Reference Standard.

5.2 PROCUREMENT OF REFERENCE STANDARD :

  • Send requisition mail to agency for required reference standard.
  • Get the proforma invoice with details of Reference Standard from respective agencies for the current lot.
  • Procure the  Reference Standard of IPRS, BPCRS, USP and EPCRS from respective agencies as mentioned in the respective pharmacopoeia.
  • Procure certified  Reference Standard from IFPRESS Mumbai / Central Drug  Laboratory, Kolkata / Central Drug Testing Laboratory, Mumbai / Central Indian Pharmacopoeia laboratory / Chromachemie according to the requirement.

5.3 RECEIPT OF REFERENCE STANDARD  :

  • When a new  Reference Standard is received, verify it for any intactness of the seal and appropriateness of the label which must mention LOD / Water content and assay on dried basis / on as is basis or potency.
  • Receive reference standard  only in the original container of the certifying and supplying agency with Invoice and Safety Data sheet for reference standard.
  • Collect the CRS information leaflet and batch validity statement from the internet from catalogue code number (mentioned in Invoice).
  • The Label on the container of reference standard contains the following information :
    • Name of the issuing agency
    • The name of the substance
    • Batch or Lot Number
    • Approximate quantity of material in the container
  • Enter the details of  received  Reference Standard like Sr. No., Receipt date, Name of reference standard, LOD, Assay and Pack size in Reference Standard Register. 
  • File the letter copy in the  Reference Standard file.
  • Check the quantity of  Reference Standard every six months.
  • Arrange for procurement of reference standard  If the reference standard quantity is not sufficient for future use.
  • Ensure that the entry of Reference Standard is done after each withdrawal.
  • Send the original copy of invoice to Accounts Department and preserve photocopy.

5.4 HANDLING OF REFERENCE STANDARD :

  • Handle / open the Reference standards in controlled temperature, free from fumes / smoke etc. to avoid any cross contamination.
  • Do not insert spatula or butter paper in the vial to avoid the contamination.
  • Do not transfer the balance quantity in to the original vial.
  • Allow the Reference Standard to attain the Room temperature when the vial is taken out from the respective storage condition prior to use.
  • Store the vial in prescribed storage condition after weighing of Reference Standard.

5.5 STORAGE OF REFERENCE STANDARD :

  • Store the Reference standards as per recommended conditions.
  • Store in original small air tight container in refrigerator (2ºC to 8º C).
  • Avoid possible contamination by careful handling to ensure its integrity .

5.6  DISCARD OF REFERENCE STANDARD :

  • Empty the content in a waste beaker containing water and dispose off this slurry in sink with continuous flow of water.
  • Deface the label of the Reference Standard vials.
  • Discard the vial in dustbin.
  • Record the destruction of Reference standard in Remark Column of Reference Standard Register.
 6.0 ABBREVIATIONS:
AbbreviationExpanded form
0CDegree Celsius
LODLoss On Drying
EPCRS European Pharmacopoeia Chemical Reference Substances
BPCRSBritish Pharmacopoeia Chemical Reference Substances
USPUnited States Pharmacopeia
IFPRESS Indian Foundation For Pharmaceutical Reference Standard Substances 
IPRSIndian Pharmacopoeia Reference Substances

7.0 ANNEXURES:
Annex. No.                                 Title
01Reference Standard Usage Register

8.0 SOP REFERENCES
  • GLP Guidelines

END OF THE SOP

ANNEXURES :

Annex. No. 01 Reference Standard Usage Register