Reference Standards Procurement and Handling

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 :