SOP on receipt and handling of stability samples

SOP on receipt and handling of stability samples

Objective:

• To lay down a procedure for Receipt and handling of stability samples.

Scope:

• This SOP is applicable for receipt and handling of stability samples

Responsibility:

• QC Chemist or above

Accountability:

• Head – Quality Control

Procedure:

Receipt of stability samples :

•  Samples for stability studies shall be received by Executive/Nominee stability section.
•  Executive/Nominee stability section shall verify the respective details in the stability   sample requisition slip and on the samples.
• The officer / Executive stability shall check the quantity of the samples received for the  proposed stability studies and ensure that adequate quantity of samples to complete the proposed stability studies has been submitted.
• The received samples shall be held at room temperature until they are charged to appropriate stability chamber.
• A stability study protocol shall be prepared by Executive stability as per Annexure No.A11 according to detail received from QA in Stability study requisition.

Stability samples labeling:

• The Executive/Nominee stability shall segregate the samples as per the requirement in approved stability protocol.
• The stability labels shall be affixed on the samples with reference to SOP No.
• The charging date shall be written manually on the stability labels after approval of  stability protocol and when samples are ready to charge in the identified stability chamber (s).
• The withdrawn date and station shall be written on the label after withdrawing the  samples from stability chamber at appropriate stations.

Charging samples on stability:

• The officer / Executive shall ensure that all samples have been appropriately labeled.
• The samples shall  be placed in the respective stability chambers and location of samples shall be maintained as per Annexure No. A01

Stability Samples monthly Planner:

• A monthly planner for next month shall be prepared at the last working day of  month for the withdrawn of stability samples for analysis as per Annexure No A12.
• The samples shall be withdrawn from stability chamber according to this monthly planner by QC Chemist or above.
• R. Number shall be allotted to each sample after making entry in stability samples A.R. number register.
• Samples shall be allotted to concerned analyst along with worksheet and worksheet number shall be maintained in A.R. Number register.
• The samples pulled out from stability chamber (s) shall be taken in a cupboard at room temperature .

Analysis of stability samples:

• Stability-Head shall plan the testing of the stability samples and shall assign an analyst to perform the testing.
• The analysis shall be carried out as per current STP for the product and recorded in the respective worksheet.
• The analysis initiation date and Completion date shall be entered in the A.R. number register.

Samples After completion of Analysis :

• After completion of analysis samples shall be kept in cup-board labeled as “Under-review”.
• After data review samples shall be kept in a cup-board labeled as “Samples for destruction”.
• Then these samples shall be destructed as per SOP .

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List of Annexure / Format :

 References :

• If any

Reason for Revision :

• Not applicable due to first version of SOP

Abbreviation :

• STP                   :   Standard testing procedure
• SOP                  :    Standard Operating Procedure
• A.R. Number     :    Analytical reference number
• QA                      :    Quality Assurance

Annexure 1

Stability Samples Location List

 Stability Chamber Id. No. :

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