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SOP for Stability Study of Products

To lay down the procedure for Selection of batches, Sample Requirement, Initiation, Monitoring, Evaluation of Stability Study and Preconditioning stability study of Drug Products.

This SOP shall be applicable for the Selection of batches, Sample Requirement, Initiation, Monitoring and Evaluation of Stability Study of Drug Products manufactured at XYZ Limited

Initiation - Chemist & above-QA Department
Execution- Chemist & above-QC Department.
Checking- Asst. Manager & above-QC & QA Department.

Selection of batches:
For existing products:
  • 1st optimization batch for LT and ACC,
  • 1st validation batch for LT and ACC.
  • 2nd and 3rd validation batch for ACC only.
For New products: 
  • 1st optimization batch for LT and ACC,
  • Three validation batches for LT and ACC.
For ongoing stability study: 
  • If the stability study of three batches has been completed for a particular product with existing formulation which is found stable, minimum one batch for every alternative year shall be kept for long term stability study

  • QA shall initiate the stability study and the batches selected for the stability study through stability study intimation sheet as per the format given in Annexure-3.
  • Stability study protocol shall be prepared and approved for each product as per annexure-1.
  • Numbering of protocol shall be given as SP/X/YYY/ZZ Where, SP : Stability Protocol, X : Product Code, YYYY : Serial no starting from 001, ZZ : Serial no for same product starting from 00
  • Chemist and above of QC department shall review and receive the intimation slip along with stability samples and acknowledge the same.
  • Chemist and above shall check the finished product release date. The initial finished product analysis result shall be considered as initial (0 month) stability data. If stability study is initiated after more than 30 days of initial analysis date, reanalysis must be done for “0” month (only instrumental test which are listed in the stability protocol / stability information sheet).
  • Chemist and above shall make entry in the “MASTER STABILITY SCHEDULE” register as per Annexure No.-2 after receiving the stability samples.
  • Prepare “STABILTY SAMPLE LABEL” as per Annexure No.-4 and affix it on the sample container. Incubate the samples as per the required storage conditions mentioned in the intimation slip for stability study.
  • Prepared the monthly schedule from master schedule. According to the “MONTHLY STABILITY SCHEDULE” concerned person shall schedule the analysis planning for the product being analyzed

  • Stability chemist shall arrange for the photocopy and issuance of the Stability Datasheet for the due product.
  • Due dates are to be calculated according to the kept on date e.g. for accelerated condition if a sample is kept on 21st of January then its 1st month due shall be 21st February. For long term condition if a sample is kept on 21st of January then its 3rd month due shall be 21st of April. The sample withdrawal date shall be 3 days before and after the due date. During closure periods (Holidays and factory closure) sampling will be performed after the due date. And if the sample analysis is not planned till then, then it should be stored in the refrigerator.
  • Chemist shall withdraw the samples as required.
  • QC chemist shall make entry of the sample withdrawn in “Stability Sample Reconciliation and Destruction Form as per Annexure No.-7.
  • In case if any stability station is missed, Analysis for next subsequent stability station or any other station shall be conducted and the actual date of analysis shall be mentioned in the Stability Summary Report as per Annexure No.-5. Missed stability station shall be mentioned as “Missed station” in Stability Summary Report.
  • Analysis shall be done as per respective Standard Test Procedure and enter the raw data in the respective datasheet.
  • Analysis must be completed within 15 days from the sample withdrawal dates for the accelerated study and within 21 days for long term stability study. Analysis, which requires extended time, shall be justified.
  • On completion of analysis of all tests, the chemist shall give the stability report for checking along with the raw data to the designated person.
  • After checking and approval of stability reports the concerned person shall enter the results in the stability summary report and remarks shall be given by comparing the results obtained with the evaluation parameters and from previous stability summary report. Actual date should be mentioned in summary report in case of missed / delayed analysis.
  • On completion of stability schedule analysis (all stations) of a particular batch, Head of Quality Control Department or his Designee shall give remarks by evaluating all results generated against the remarks.

Temperature and humidity monitoring:
  • The actual temperature and humidity should be monitored during stability storage to avoid any excursions.
  • The excursions during the storage conditions should be reported & if it is more than 24 hours then the suitable corrective & preventive action shall be taken. If instrument malfunctioning is observed then switch off the instrument and inform the engineering department for rectification and if instrument is not rectified within 48 hours then shift the samples to another location or chamber.
  • If the temperature exceeds 10°C more than the set value for more than 24 hours because of malfunctioning of the equipment, then the study may be discontinued.

Evaluation - Handling of Significant changes and Failure:
  • Significant changes are defined as follows:
  1. 5% potency loss from the initial assay value of the batch.
  2. Any specified degradant exceeding its specification limit.
  3. The product exceeding its pH limits.
  4. Dissolution exceeding the specification limit of 12 capsules or tablets.
  5. Failure to meet specification for appearance and physical properties.
  • In case any significant change occurs, Head QC & QA or his Designee shall evaluate the data and confirm significant changes / failure, & shall suggest an additional testing as follows.
  • In case significant change occurs in accelerated condition, samples from real time shall be withdrawn in triplicate for analysis.
  • If sample does not meet the specifications, Head QC or his Designee shall investigate the out of specification (OOS) results and final conclusion shall be given by Head Quality Assurance.
  • Head Quality Assurance shall discuss with technical group comprising of Plant Head, Head Production and Head QC to take joint decision for recall/ revision of formulation / revision in product storage conditions

SOP : Standard Operating Procedure
Asst. : Assistant
No. : Number
Qty. : Quantity
QA : Quality Assurance
QC : Quality Control
BOM : Bill of Material
BMR : Batch Manufacturing Record
Mfg. : Manufacturing
ACC : Accelerated
LT : Long term

Annexure No.-1 : Stability study protocol
Annexure No.-2 : Master stability schedule
Annexure No.-3 : Sample Intimation slip
Annexure No.-4 : Stability sample label
Annexure No.-5 : Stability summary report
Annexure No.-6 : Monthly stability schedule
Annexure No.-7 : Stability sample reconciliation and destruction form

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  1. Dear Mr. Mubarak, unable to download the annexure; please advice, what to do?