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Standard Operating Procedure (SOP) for withdrawal and analysis of Stability Study Samples (Finished Drug Product) from stability chambers.

Withdrawal and Analysis of Stability Study Samples

1.0   PURPOSE:

• • The purpose of this  SOP is to define the procedure for Withdrawal and Analysis of Stability Study samples from the stability chamber.

2.0   SCOPE:

• • This SOP is applicable for Stability Study Section for sending the samples outside the plant for analysis in the Quality Control Department at the pharmaceutical drug manufacturing plant.

3.0   REFERENCES:

• • SOP on stability Program.

• • SOP on Sampling Procedure for withdrawal of Stability Study Samples.

4.0   RESPONSIBILITY:

• Quality Assurance shall be responsible for :

• • Send the stability study test request form.

• • Provide the stability study samples to the Quality Control Department

• • Maintain the related documents.

• Section Head or Designee shall be responsible for :

• • Receive, schedule/ program, incubate, withdrawn, and plan for analysis of stability study samples.

• • Inform any OOS, out of trend, significant change or any stability failure results to Head QC or Designee.

• • Prepare stability study summary report and Evaluation.

• • Maintain stability documents and records.

• Quality Control Head or Designee shall be responsible for :

• • Ensure for the receiving, scheduling, incubation, and analysis of stability study sample as per SOP.

• • Verify the stability study sample schedule as per the SOP.

• • Initiate investigation in case of OOS result/ stability failures.

• • Review the stability summary report.

• Site Quality Head or Designee shall be responsible for :

• • To approval SOP.

• • Implementation of the system as per SOP.

5.0   ABBREVIATIONS & DEFINITION:

• • ACC : Accelerated condition

• • BMR: Batch manufacturing record

• • LTC: Long Term Condition

• • NA : Not applicable

• • NRGP : Non-Returnable Gate Pass

• • OOS : Out of Specification (Related – SOP for Handling of OOS Results)

• • SOP: Standard Operating Procedure

• • Stability:

• • The term with respect to a drug dosage form refers to the chemical and physical integrity of the dosage unit and when appropriate, the ability of the dosage unit to maintain protection against microbial contamination.

• • Accelerated testing:

• • Studies designed to increase the rate of chemical degradation or physical change of drug products by using exaggerated storage conditions as part of the formal stability studies.

• • Long Term Testing:

• • Stability studies under the recommended storage condition for the proposed or approved shelf life for labeling.

6.0   PROCEDURE FOR HANDLING STABILITY STUDY SAMPLES:

• • Withdrawal of Stability Study Samples :

• • After receiving the stability samples from the QA department stability section head or Designee shall verify the details such as “Batch Number “, Quantity of stability study sample” etc.

• • Section head or Designee shall make the entry in Stability samples receiving and transferring the tracking register (Annexure-1).

• • Schedule the stability Program and shall make an entry in the Master Stability Schedule (Annexure – 2) as per SOP.

• • Section head or designee shall make the entry in the Monthly Schedule for Stability (Annexure-6).

• • Section Head or Designee shall divide the stability sample quantity according to the stability conditions/no. of stations.

• • Trained Manpower or Designee shall affix the respective label (ACC and LTC) on stability study samples as per SOP.

• • Section head or Designee shall make the NRGP for transferring of product for incubation at other locations lab within 15 calendar days from the stability samples received from QA as per SOP.

• • Section head or Designee shall arrange the facility to send the sample at other locations lab.

• • Analysis of Stability Study Samples :

• • Section head or Designee shall-

• • • Make the respective entry (ACC and LTC) in Stability samples charging and withdrawal tracking register (annexure-2 and Annexure-3).

• • • Incubate the stability samples in the stability chamber as per the respective SOP for Stability Study (Link available in the reference section).

• • • Update the Master Stability schedule and Sample Reconciliation and Destruction sheet as per SOP.

• • • Withdrawal the stability samples of the due product station from the respective chamber in specified quantity at the time of analysis from other locations lab.

• • • After the withdrawal of stability study samples as per SOP (SOP for Stability Study) shall keep the sample in a suitable controlled temperature area or as per product storage condition.

• • • Make the respective entry (ACC and LTC) in Stability  samples charging and withdrawal tracking register (Annexure-2 and annexure-3).

• • • Arrange the facility to send the sample from other locations lab to the main plant for analysis purposes.

• • • Schedule the analysis, planning, and issue the stability template for stability analysis according to the stability schedule.

• • • Make the entry of Sample withdrawal in Stability Sample reconciliation and destruction logbook for Qty. drawn, Qty. drawn date/by, Station no. / Due on, Qty. balance and remarks. (Annexure-10) as per SOP (SOP for Stability Study)

• • The analyst shall analyze the samples as per the test procedures given instability Template.

• • On completion of the analysis of all the tests, the analyst shall enter the results in the Stability summary report as per (SOP for Stability Study).

7.0   DISTRIBUTION – SOP FOR STABILITY STUDY SAMPLES:

• • Quality Control.

• • Quality Assurance.

8.0   ANNEXURES –SOP FOR STABILITY STUDY SAMPLES:

Annexure-1: Stability of samples receiving and transferring tracking Register.

*RU = Receiving Unit

Annexure-2:  Stability Samples charging and Withdrawal tracking register for ACC.

*RU = Receiving Unit

Annexure-3: Stability Samples charging and withdrawal tracking register for LTC.

*RU = Receiving Unit

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