Standard Operating Procedure for Receipt, Storage and Handling of Primary Standards

1.0 Purpose:

2.0 Scope:

3.0 Responsibility:

4.0 Definitions

5.0 Procedure:

6.0 Acceptance Criteria:

7.0 Frequency:

8.0 Format for recording:

To lay down a procedure for Receipt, Storage and Handling of Primary Standards.

The scope of this SOP is applicable for Receipt, Storage and Handling of Primary Standards in the Quality Control Department at [company name].

QC Personnel: To Procure, Receipt, Store and Handle the Primary Standards.

Head QC/ Designee: To monitor the activity.

5.1 The Primary Standard is used for the standardization of the Volumetric Solution.

5.2 The expiry or validity of the Primary Standard shall be as mentioned in the supplier’s certificate or on the bottle label.

5.3 In case the supplier of the Primary Standard does not mention the expiry or validity date on the certificate or bottle label, it shall be considered three years from the opening date of the bottle.

5.4 The Primary Standard bottle shall be tightly closed after every usage.

5.5 A list of Primary Standards shall be maintained as per the respective format.

5.6 Chemical reagents and solvents used as standards shall be considered primary standards.

5.7 If the storage condition is not mentioned on the container label of the Primary Standard, it shall be considered from MSDS or COA of reagent and the label of that storage condition shall be affixed on the container of the Primary Standard.

5.8 If the storage condition is not available from any of the above reliable sources or any other reliable source (e.g., literature), the Primary Standard shall be stored at room temperature and a label for the same shall be affixed on the container.

5.9 Handle the Primary Standards carefully.

5.10 Avoid contamination of Primary Standards during storage and handling.

5.11 Do not put dispensed quantity back into the Primary Standard bottle.

5.12 Procurement of Primary Standards:

Primary Standards shall be procured from standard stipulated sources, i.e., E. Merck, Ranbaxy, Lancaster, etc.
The requisition for the requirement of Primary Standards shall be made to the Purchase Department through mail specifying the name, required quantity, source, and necessary entries shall be made in the “Material Requisition Register”.

5.13 Receipt of Primary Standards:

The requested Primary Standard is received by Stores Department and inventory shall be done in SAP. The material shall be hand over to QC Person along with the Challan and other documents (like Supplier’s Certificate, etc).
QC Person shall check the Supplier’s Certificate, requested Quantity, Grade and shall make the necessary entries in the “Challan Logbook”.
QC Person shall make remark on the Challan as “Received By” with signature and date and shall return the copy of Challan to the Store Person for the further processing.
In case the Primary Standard received is not as per the requisition made, QC Person shall make remark on the Challan as “Not Received” with signature and date and shall return the copy of Challan and Primary Standard to the Store Person for the further processing.
QC Person shall bring the Primary Standard to the Quality Control Department and shall complete the remaining entries in the “Material Requisition Register”.
He / She shall label the Primary Standard bottles and shall assign the code number as follows;

[Define Numbering system as per company policy]

Once the code number is assigned to the particular Primary Standard, it shall remain same for the second time receipt of same Primary Standard.
For Eg.: For Primary Standard, Sodium Nitrite code number is assigned as PS – 01 for first time receipt and shall remain the same in case new lot of Sodium Nitrite is received.
In case the new Primary Standard is procured, it shall be updated in the “List of Primary Standard”.

5.14 Storage of Primary Standards:

5.14.1 QC Person shall store the Primary Standards in the desiccators or as per the condition recommended on the Supplier’s Label.

5.15 Handling of Primary Standards:

During usage, QC person shall take the Primary Standard bottle from the desiccator or designated place. In case the bottle is new, QC Person shall mention the Opening Date on the label before usage.
He / She shall dispense the required quantity.
After usage the Primary Standard bottle shall be closed properly and kept at its designated place and shall make necessary entries in the “Primary Standard Consumption Record”.
In case any change in the appearance or any lump formation is observed while using the Primary Standard before its Expiry inform to the Supervisor and the primary standard shall be discarded as per SOP for Disposal of Left Over Samples and Scrap and new bottle shall be issued.

Not Applicable.

As and when required.

Opening Date

Usage Date

Quantity Used

Balance Quantity

Signature and Date

Discarded By and Date

8.1 Format for “List of Primary Standard”.

Sr. No.	Name of Primary Standard	Make	Batch No.	Code No.	Expiry

8.2 Format for “Primary Standard Consumption Record”.

Name of Primary Standard :

Batch Number of Primary Standard :

Make of Primary Standard :

Code of Primary Standard :

Expiry of Primary Standard :

Quantity Received :

SOP Reference No. :

8.3 Format for “Primary Standard Label”.

PRIMARY STANDARD

Name
Batch No.
Code No.
Opening Date
Physical state
Storage Condition
Expiry Date

8.4 Format for “Material Requisition Register”.

8.5 Format for “Challan Logbook”.

Sr. No.	Material Name	Quantity	Challan No.	Challan Date	Supplier	Material Given By and Date	Received By and Date	Remarks