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 in Quality Control Laboratory.

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 have been submitted.

The received samples shall be kept at room temperature or at recommended storage temperature until they are charged to appropriate stability condition.

A stability study protocol for individual batch shall be prepared by Executive stability or nominee according to detail received from QA in Stability sample requisition slip.

Executive stability or nominee shall prepare the summarized protocol for exhibit batches and summarized protocol for commercial batches

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.

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).

Executive or nominee shall prepare and update schedule for charging and analysis of stability samples.

The withdrawn date and station shall be written on the label after withdrawing the samples from stability chamber at appropriate stations.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.

Stability samples monthly Planner:

A monthly planner for next month shall be prepared at the last week of month for the withdrawn of stability samples for analysis.

The samples shall be withdrawn from stability chamber according to this monthly planner by QC Chemist or above.

Analysis of stability samples:

R. Number shall be allotted to each sample after making entry in stability samples A.R. Number register.

After withdrawal of sample from stability chamber (s), samples shall be kept at room temperature or recommended temperature as per labeling.

Samples shall be allotted to concerned analyst along with worksheet and worksheet number shall be maintained in A.R. Number register.

Stability Section-Head shall plan the testing of the stability samples.

The analysis shall be carried out as per current version of Specification and STP of respective product and raw data shall be recorded in the respective worksheet.

The analysis initiation date and completion date shall be entered in the Stability sample A.R. number register.

After completion of analysis, samples shall be destructed as per SOP.

List of Annexure – Stability Samples Location List

Categories: Quality Control
shivpharma2016: