Sop for handling of Primary Standards

This Document describes (Standard Operating procedure) Sop for handling of Primary Standards

Sop for handling of Primary Standards

I. Purpose & Scope:

• The purpose of the SOP is to lay down a procedure for handling of Primary Standards
• This procedure is applicable for handling of Primary Standards used in Quality control Laboratories

II. Responsibilities:

• All Quality Control and Quality Assurance personnel’s shall be responsible to follow and implement this SOP.

III : Introduction and Procedural Part :

Definition :

• Primary Standard: High purity material that is acknowledged to have appropriate characteristic within a specified context and whole value is accepted without requiring comparison to another substance. This is supplied by the manufacture.

Procurement of primary standards: 

• The requirement of Primary Standard shall be given to Purchase department by Head QC or designee.
• Purchase order shall be raised for the desired “Primary Standard” to be procured from sources.
• New Primary standard shall be procured in Change in Batch No. / Lot No. or Expire which is earlier
• Store all Primary standards as per the storage condition mentioned in respective COA from supplier.
• Primary standard for non-pharmacopoeia materials shall be arranged from related Manufacturer/ supplier along with COA.

Procedure for receipt and storage of primary standard : 

• Primary standard shall be received in the original container of the certifying and supplying agency.
• On the receipt of Primary standards, entry shall be made in “Primary Standard Inward Register” refer Annexure I.
• Primary standard shall be stored in its original stopper container.
• List shall be Prepared of all Primary standard as per Annexure II

Handling of primary Standards : 

• Precautions shall be taken during handling of primary standard to avoid cross-contamination, to avoid exposure to light and moisture.
• Where drying is recommended, a small quantity shall be transferred to a clean dry container for drying and the original container shall not be dried as such temperature before weighing. Takeout the Primary standards bottle and keep in desiccators and allow it to equilibrate with room temperature. Material taken out for weighing that is an excess of the requirement should not be returned to the container of the standards hence very small amount must be removed at a time.
• The consumption record of the Primary standard shall be maintained refer Annexure III.
• Analyst has to ensure the validity of the Primary standard before starting the analysis and seal the Primary standard vial with aluminum seal after every use.
• Vials which are in current use and to be stored at ambient condition shall be stored in a desiccators containing self-indicating silica gel.
• Self-indicating silica gel can be used up to one year. If the color of Silica gel is changed from blue to white, it shall be dried at 105°C, till the color of silica gel becomes blue.
• Do not insert any of the dispensing equipment like spatulas, glass rods, and butter paper in to the Primary standard containers.
• Excess material after weighing shall not be returned to the container
• The vials remaining after the validity date of respective Primary standards shall be destroyed.

Disposal of primary standard: 

• Expired Primary Standards should not be used and should be disposed immediately.

Annexure :

Annexure I      :  Primary Standard Inward Register

Annexure II     :  List of Primary Standard

Annexure III     : Consumption Record of Primary Standard

Annexure-I

Primary standard inward register 

Annexure -II

List of Primary standards

Prepared by:                                      Checked by:                                  Head QC

Date:                                                    Date:                                              Date:

Annexure -III

Consumption Record- Primary Standard