Procedure For Stability product handling and testing

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Procedure For Stability product handling and testing

1.0 Objective
Objective of this Standard Operating Procedure is to provide guidelines for Stability product handling and testing.
2.0 Scope
Standard Operating Procedure is to provide guidelines for Stability product handling & testing in the

quality control department at abc company.
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 Selection of Batches
5.1.1 For Submission
Stability information study from accelerated and long term testing is to be provided on

at least three consecutive batches.
5.2 Sampling Considerations
5.2.1 The selection of containers from the batches selected for stability studies should

be carried out so as to ensure that the samples chosen represent the batch as a whole.

As a rule, dosage units should be sampled randomly, with each unit having an equal chance to be included in the sample.
5.3 Sample Orientations
5.3.1 Products should be stored in both the upright and either inverted or on-the side positions

until contact with the container/ closure system has been shown not to impact on drug product quality.
5.3.2 The evaluation should include the set of test parameters that are listed for specific dosage form.
5.3.3 Once it has been demonstrated that the product in maximum contact with the primary

pack does not have a significantly greater impact on drug product quality than the upright orientation, stability studies may be
5.3.4 Continued only in the most stressful orientation, which is generally the inverted or on-the –side position.
5.4 Test Criteria and Test Procedures
5.4.1 The testing should cover as necessary the physical, chemical, and microbiological test characteristics.

Validated stability indicating testing methods should be applied.
5.4.2 Evaluation of samples should essentially include following test parameters, but should not be limited to these.
a) Appearance
b) Clarity
c) pH
d) Assay
e) Disintegration
f) Dissolution
g) Related substances
5.5 Specifications
5.5.1 Limits of acceptance should relate to the finished product limit (where applicable), In general the

product on stability should meet the claimed specifications for the tests listed in the respective monograph.
5.6 Storage/ Test Conditions
a) Long- term stability
Studies are carried out at 30+2C and 65+5 %RH.
b) Accelerated stability
Studies are carried out at 40+2C and 75+5 %RH.
5.7 Testing Frequency
5.7.1 The testing frequency to be followed for Accelerated and long-term stability studies is described as below.
5.8 Long- term stability
5.8.1 It is a real time testing carried out for a sufficient time to cover shelf life. Testing under the defined

long-term conditions will normally be every 3 months over the first year, every 6 months over the second year, and then annually.
5.9 Accelerated stability
5.9.1 Accelerated stability is carried out for 06 months. The testing frequency will be at 1 month, 2 month & 6 month.
5.9.2 Mention the time period allowed to test the sample against the due date of analysis. On the date

of analysis the samples shall be withdrawn from the Humidity Controlled oven and kept at controlled

room temperature. The samples shall be analysed as per the STP’s.

6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History