SOP ON STABILITY OF FINISHED PRODUCT

1.  Purpose

This document details the procedure for the stability of finished product to be carried out in
ABC Pharmaceuticals

2. Objective

It is the policy of ABC Pharmaceuticals that a written procedure shall be followed for the
stability studies of finished product to assure the efficacy and safety of the drug products
manufactured by ABC Pharmaceuticals throughout the shelf life of the products and
products remain within specifications under the labelled storage conditions to meet the
regulatory requirements.     

3. SCOPE:

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:

i)  Major deviation in process

ii) New equipments

iii) New sources of raw material

iv) hange in primary packing material

v) One batch annually

4. RESPONSIBILITY

Persons along with their responsibilities are given below:

S. No Designation Responsibility
01 Executive - Corporate To prepare and follow the SOP
 accordingly. Maintain the record as
Quality Assurance per SOP.
02 Manager - Quality Control To ensure implementation of SOP
Manager - Quality
03 Assurance To ensure implementation of SOP.
Manager - Corporate Quality
04 Assurance To ensure implementation of SOP

5. PROCEDURE

5.1 GENERAL

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

5.1.2 Sample shall be incorporated into the stability programme at all storage conditions (as
applicable) on the same date.

5.1.3 In case the sampling falls on holiday(s), the sample shall be withdrawn from the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

5.1.4 The samples kept at different storage conditions shall be withdrawn at the stipulated
time interval and to be analysed within 15 days.  During this period the sample shall be
stored in refrigerator at 2ºC to 8ºC.

5.2 PURPOSE OF STABILITY STUDIES

5.2.1 To understand any chemical/ physical changes occur to the formulation due to the
exposure of different environmental conditions.
5.2.2 To confirm that Drug Products are assured for their efficacy and safety in marketed
packs   throughout the cycle of warehousing, distribution, storage and uses.

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

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

5.2.5 To support and assured the Drug products registration in different countries.

5.3 REGULAR STABILITY STUDIES

5.3.1 Long term stability studies shall be done at two different storage conditions for shelf
life, considering the climatic zones.

I)  Temperature             : 25 ± 2ºC

    Relative Humidity    : 60 ± 5%

II) Temperature             : 30 ± 2ºC (Intermediate Condition for Zone I & II)

    Relative Humidity    : 65 ± 5%

5.3.2 Intermediate stability data for climatic zone I & II shall be collected from long term
stability data of climatic zone III & IV (if required)

5.3.3 Accelerated stability study shall be done at following storage condition up to six

months.

             Temperature             : 40 ± 2ºC

            Relative Humidity    : 75 ± 5%

5.3.4 Storage period for stability studies can be extended after shelf life, which shall be
addressed    in specific protocol(s).                                                                                       
5.3.5 Initial optimisation and validation batches and subsequently minimum one batch
(preferably first batch of the year) per year shall be subjected for stability studies
(“Initially” means the product is subjected for stability for the first time at the location).

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

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

5.3.8 Q.A. department shall ensure that these samples are packed in simulated market
packing.

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

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

5.3.11 The samples shall be analysed for the different parameters as per the guidelines given
in the protocol (product specific).

5.3.12 In case of long-term stability studies, the sample shall be analysed 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.

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

5.3.14 In case of accelerated stability studies samples shall be analysed at an interval of 3

months and 6 months.
5.3.15 The stability studies shall be discontinued if there shall be any loss of chemical
purity / potency / efficacy / safety of the product as observed after analysis and reviewing
the analytical results, by technical committee, below the acceptable criteria as per the
respective specification.