SOP for Stability of Finished Goods | Accelerated Stability Studies

This document details the procedure for the stability of the finished product to be carried out in XYZ Limited. It is the policy of XYZ Limited that a written procedure shall be followed for the stability studies of the finished products to assure the efficacy and safety of the drug products manufactured by XYZ Limited, by the client, or by a tie-up company throughout the shelf life of the products and products remain within specifications under the labeled storage conditions to meet the regulatory requirements.

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This procedure is to be applied at the time of manufacturing of new formulation in the company and its routine observation and but not limited to:

Major deviation in the process

New equipment

New sources of raw material

Change in primary packing material

One batch annually


Persons along with their responsibilities are given below:

Executive  - Corporate Quality Assurance:- To prepare the SOP. Maintain the record as per SOP.

Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To follow the SOP accordingly

Manager -Quality Control/ Quality Assurance:- To ensure implementation of SOP

General Manager – Technical:- To ensure implementation of SOP

Procedure Of stability studies of finished goods


“Initial” (Zero) month shall be defined as the “date of testing of finished product sample” and in case the product is packed for stability purposes, prior to actual packing operation, the date of testing will be considered as initial (zero) month.

A sample shall be incorporated into the stability program at all storage conditions (as applicable) on the same date.

In case the sampling falls on a holiday(s), the sample shall be withdrawn from the stability chamber/storage conditions on the next working day.

The samples kept at different storage conditions shall be withdrawn at the stipulated time interval and to be analyzed within 15 days ( in case of long-term stability) and within 7 days (in case of accelerated stability).  During this period the sample shall be stored in a refrigerator from 2ºC to 8ºC.


To understand any chemical/ physical changes that occur to the formulation due to the exposure to different environmental conditions.

To confirm that Drug Products are assured of their efficacy and safety in marketed packs throughout the cycle of warehousing, distribution, storage, and use.

To compile data for confirming the storage conditions, retest period, and shelf life.

To monitor the impact of any chemical or physical change(s) in the manufacturing process and/or Recipients on product quality

To support and ensure the Drug product's registration in different countries.

Accelerated stability studies

Long-term stability studies shall be done at 30˚ C + 2˚C / 65 + 5% Rh
conditions for shelf life, considering the climatic zones.

An accelerated stability study shall be done at the following storage condition up to six months.

Temperature: 40 ± 2ºC

Relative Humidity: 75 ± 5%

5.3.3 The storage period for stability studies can be extended after shelf life, which shall be addressed in a specific protocol(s).

Initial optimization and three validation batches and subsequently a minimum of one batch (preferably the first batch of the year) per year shall be subjected to stability studies (“Initially” means the product is subjected to stability for the first time at the location).

Products for initial stability studies shall be subjected to long-term and/or Intermediate and accelerated stability studies, depending upon the market (Zone Wise) for which the product is manufactured.

5.3.6 Products for subsequent ongoing stability studies shall be subjected to long-term stability studies, depending upon the market (Zone Wise) in which the product is manufactured.

5.3.7 The Quality Assurance department shall ensure that these samples are packed in simulated market packing.

5.3.8 Sample quantity shall be sufficient to carry out repeat analysis as per the scheduled frequencies at different storage conditions.

5.3.9 A sampling schedule is prepared and fresh samples shall be included as and when required.

5.3.10 The samples shall be analyzed for the different parameters as per the guidelines given in the protocol (product-specific).

5.3.11  In the case of long-term stability studies, the sample shall be analyzed at an interval of 3  months, 6 months, 9 months, 12 months, 18 months, 24 months, and annually thereafter till the shelf life of a specific product.

The long-term stability data of Zone III & IV (Temperature 30o+ 2oC & RH 65 %  + 5%) at an interval of 3 months, 6 months, 9 months, and 12 months and also considered for intermediate stability study of Zone I & II (if applicable).

In the case of accelerated stability studies, samples shall be analyzed at an intervals of 01, 03 months, and 6 months.

SOP For Stability of Finished Products.

The stability studies shall be discontinued if there is any loss of 5% of its initial value of chemical purity and potency/efficacy/safety of the product as observed after analysis and reviewing the analytical results, by a technical committee, below the acceptance criteria as per the respective specification.


Accelerated stability testing

Additional stability studies under stress conditions shall be done (if required) to check the stability of the drug products.

The following conditions are suggested for stress testing of drug products: Increments of 5°C or 10°C higher than an accelerated temperature of 40°C to cover the studies of the influence of dry heat on drug products. This test is to simulate hot conditions faced by drug products during transportation and shipment. Simultaneous exposure to 40°C and a minimum of 1.2 million lux h fluorescent light and 200W h/m2 UV light. This test is meant to study the influence of tropical conditions on drug products. Any other storage conditions specified by regulatory authorities or any tie-up companies. The stress testing shall be done on a single and initial batch of a product, which must be of the same formulation and quality as the marketing product, including the packaging. The stress testing shall be conducted at the time interval of 1 month, 2 months, and 3 months.

Additional stability studies shall be done in case (but not limited) of major deviation in process, new equipment, new sources of raw material, and/or change in primary packing material but depth of studies like no. of batches, storage condition(s) shall be decided based on risk assessment.

5.4.3 Additional stability studies shall be carried out for the same batches kept for regular stability studies beyond the stipulated time intervals/conditions as per the directives received from Tie Up Company or location Quality Assurance

5.4.4 Additional stability studies shall be carried out as per the customer’s requirement based on the storage conditions and the frequencies of analysis as given by the customer.

5.4.5 Additional stability studies shall be carried out as per the directions received from the “Change Control Committee”.

5.4.6  Additional stability studies shall be carried out as per the requirement of Tie Up Company or the direction of Regulatory agencies(s) at any other specified temperature and RH conditions.


5.5.1  The IPQA(In-process Quality Assurance) personnel shall collect the product samples for stability studies from one optimization and three validation batches and subsequently a minimum of one batch (preferably first batch of the year) per year including all different packing like blisters, strips, and/or containers, etc shall be considered.

5.5.2 The Quality Assurance department shall inform the warehouse in charge of the stability plan with the product name, batch number, and sample quantity. IPQA personnel shall collect the stability sample from a warehouse.

5.5.3 The Quality Control department/ Analytical division shall label the stability samples individually with colored labels specified as per the SOP Labeling Policy.

The quality Control department/ Analytical division shall put the samples at different storage conditions in stability chambers and maintain the storage record on the SOP Finished Product Stability Sample Storage Record (Appendix). 

Withdraw the samples as per the schedule and maintain the record on APL/CQA/SOP-016/FR-02 Accelerated Stability Withdrawal Record (Appendix) and SOP Long Term Stability Withdrawal Record (Appendix).

Bracketing of product

In case the product has an identical formulation but there are different packing configurations with the same primary packing material, then anyone type of packing configuration shall be chosen and samples shall be collected.

If a product is manufactured under different brand names but the formulation, strength, and manufacturing process remain the same with the same primary packing materials then samples of anyone brand name shall be collected.


Maintain the record for storage and withdrawal of finished product stability samples as per the respective appendix.

A monthly schedule shall be prepared on Annexure-II and a copy of the same to the Quality Control - Head.

Send the information to the Quality control department/ Analytical division for storage of the stability sample with details like product name, mfg. date, expiry date, sample quantity, date of collection, storage conditions, and stability intervals in Appendix II and/or Appendix III depending upon their requirement.

A calendar for stability study shall be prepared by the Quality Control department/ Analytical division for the products undergoing stability studies.

A stability study protocol shall be prepared and studies shall be executed accordingly.

A logbook for receiving and issuance of stability samples shall be maintained by the quality control department.

The raw data of analytical studies of stability products shall be recorded in the test protocol. 


Analytical reports and supporting data like chromatograms/charts/graphs, etc. shall be cross-checked by the Quality control department / analytical division for the correctness of results, calculations, formulae used for calculating results, analytical findings, and observations and shall be countersigned.

Unusual observations shall be highlighted in the report and shall be informed to Tie Up Company and/or Regulatory agency with necessary details.

Composite data shall be prepared at the time of submission as per the requirement of that company.


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