SOP on procurement and handling of working standards

• SOP on procurement and handling of working standards

• Objective:To lay down a procedure for the procurement and handling of working standards.

• Scope:This SOP is applicable for procurement and handling of working standards in quality control laboratory of pharmaceutical company name with location.

• Responsibility:Chemist or above of QC laboratory shall be responsible for follow the procedure mentioned in this SOP.

• Accountability:Department Head & QA Head shall be accountable for implementation of this SOP

• Procedure:

• Preparation and Qualification of working standards.

• All actives working standards are qualified against the current lot of the reference standards.

• The analyst shall verify the current lot of the reference standard with the official catalogue before starting the analysis.

• Any unexpected  reason like non availability of Reference Standard from Pharmacopoeia commission or delay in procurement, the existing Lot of Reference Standards can be used for the qualification, with prior approval from QA.

• For qualification of working standard, assay, Loss on drying or water is carried out in triplicate, and remaining tests are carried out once as per standard test procedure.

• The RSD for three values of assay should not be more than 1.0 %.

• Prepare the working standard report.

• Being small quantity of reference standard, weight taken for analysis may be reduced without changing concentration of final dilution. This is done with prior permission from Head QC or his nominee.

• The working standard qualification reports are maintained as follows;

  • Working standard Number

  • Name of material

  • Batch No.

  • Mfg Date

  • Date

  • Manufacturer / Supplier name

  • Reference standard as per following details:

    • Batch No. / Lot No.

    • Mfg Date if applicable

    • Date if applicable

    • Potency

    • Manufacturer / Supplier name

    • Water / LOD

• After qualification of working standard, affix the label.

• Prepare COA of working standard.

• The working standard shall be re-qualified if there is a change in official lot of respective reference standard.

• Keep the working standards into desiccator’s containing silica gel, sealed with teflon tape and keep desiccator into refrigerator (Temperature range: 2°C to 8°C) or as per specified in monograph.

• Maintain the working standard Issuance record as per Annexure and keep it in desiccator with silica in to the refrigerator.

• After use of vial of working standard, seal the vial with Teflon tape; keep it into the desiccator of working standard in the refrigerator.

• The validity period of working standard shall be six months from the date of preparation or expiry of the raw material from which working standard is prepared whichever is earlier.

• Avoid any contamination in working standard while handling it and do not transfer extra material into the vial which is taken out.

• Ensure before using working standard, temperature of vial to room temperature.

• Ensure validity date of working standard before use on the label.

• Quantity of working standard shall be prepared minimum 10 vials x 1.5 gram (1 vial for 15 days) for routine usage in laboratory and 1 vial x 5.0 gram for sending for outside party or regulatory requirements.

• Remaining quantity (if any) of issued vial at the end of every 15 days shall be destroyed by dissolving in suitable solvent & thereafter discarding the solution.

• Discard the working standard after the expiry of the validity period.

• Maintain the consumption record of working standard as per Annexure.

• Numbering of working standard:

• The numbering system of working standard shall be five characters and alphanumeric by nature.Ex.  WS-XX-YY.

• Where “WS” represent the working standard

• The third character shall be dash (-).

• The fourth and fifth character represents the serial number of working standard.

• The six character shall be dash (-).

• The seven and eight character represents the preparation year year  of working standard.

• Forms and Records (Annexures)

• Working standard issue record- Annexure-I

• Working Standard Consumption Record – Annexure-II

• Distribution

• Master copy – Quality Assurance

• Controlled copies – Quality Assurance  &  Quality Control.

• History

  Date	Revision Number	Reason for Revision
  –	00	New SOP

                                                             Annexure-I

                                           Working standard issue record

WORKING  Standard  No. :                                      Qty:

Name of Material:                                            Batch No.:

                                                             Annexure-II

                                          Working Standard Consumption Record

Working Standard Name:                                                   A.R. No. :

Working Standard I.D     :

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