Stability Study Overview | Stability Zones In Pharma

Stability Study Overview | Stability Zones In Pharma

In this post, we will go through the Stability Studies and stability zones in the Pharma industry. I know many people have too many questions regarding this stability topic, but we will discuss it in fragments because stability is a very vast topic.

In this post, we will see only the general look out of the Stability study. for more details refer to my blogs as I tried to overlook all sides of stability study in different blogs.

What is a stability study? 

We will see from the scratch. Stability means how any material is stable in some conditions. Here we look at the case of Finished Product or Active Pharmaceutical Ingredient (API). How that Finished Product or API is stable in some environmental conditions like temperature, humidity, and light for some given period of time. Now Stability Study means we Study the effect of such factors on the stability of Finished Product or on API.  Apart from these environmental factors like temperature, humidity, and light some other factors also influence the quality of product like container closure system, packaging material, the interaction between API and excipient or within excipients.

why does this stability study is performed?

Now next question is why do this stability study in the pharmaceutical industry? The first reason for this is the regulatory requirement as we need to submit this stability study data while we are filling a new product or API. Regulatory authorities ask for the stability data. The second reason, there is a need for this stability study is to identify the Stability of the finished product and API from which one can find out the shelf life of the product. This study gives us confidence in the stability of the product for a given period in such conditions. This stability study data will be evidence of how the finished product or API is varying according to the temperature, humidity, and light.

Here we are clear about the basics of stability study actually what it is and why to do it? Now we know that we have to do stability study but how to do it? This is the general question may you rise in your mind. We don't need to think about it because there are some regulatory guidelines by ICH that provide us detail knowledge about how to do stability study. There are different guidelines for a Stability study. 

Q1A: Stability testing of new drug substances and products 
Q1B: Stability testing: Photostability testing of new drug substances and products Q1C: Stability testing for new dosage forms 
Q1D: Bracketing and matrixing designs for stability testing of new drug substances and products
Q1E: Evaluation for stability data 
Q1F: Stability testing of API and finished Pharmaceutical products (it withdrew from the ICH website)

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Stability Zones:

There are some climatic zones of the ICH Stability Study. The world is divided into the following zones depending upon its environmental condition.

Zone	Type of climate
Zone I	Temperate zone
Zone II	Mediterranean/ Subtropical zone
Zone III	Hot Dry zone
Zone IV a	Hot-Humid/ Tropical zone
Zone IV b	Hot/ Higher Humid zone

Depending upon zones stability conditions for Long term Stability testing

Zone	Temperature	Humidity	Duration
Zone I	21 0C ± 2 0C	45 % RH ± 5 % RH	12 months
Zone II	25 0C ± 2 0C	60 % RH ± 5 % RH	12 months
Zone III	30 0C ± 2 0C	35 % RH ± 5 % RH	12 months
Zone IV a	30 0C ± 2 0C	65 % RH ± 5 % RH	12 months
Zone IV b	30 0C ± 2 0C	75 % RH ± 5 % RH	12 months
Refrigerated	5 ± 3 0C	No Humidity	12 months
Frozen	-15 ± 5 0C	No Humidity	12 months

Accelerated and Intermediate Stability testing conditions:

Climatic Zone	Temperature	Humidity	Duration
Accelerated Ambient	40 0C ± 2 0C	75 % RH ± 5 % RH	6 months
Accelerated refrigerated	25 0C ± 2 0C	60 % RH ± 5 % RH	6 months
Accelerated Frozen	5 ± 3 0C	No Humidity	6 months
Intermediate	30 0C ± 2 0C	65 % RH ± 5 % RH	6 months

General Stability Study conditions:

Study	Storage condition	Minimum period
Long term	25 0C ± 2 0C/ 60 % RH ± 5 % RH or	12 months or 6 months
	30 0C ± 2 0C/ 65 % RH ± 5 % RH or
	300C ± 2 0C/ 75 % RH ± 5 % RH
Intermediate	30 0C ± 2 0C/ 65 % RH ± 5 % RH	6 months
Accelerated	40 0C ± 2 0C/ 75 % RH ± 5 % RH	6 months

Stability study storage condition for refrigerated products:

Study	Storage condition	Minimum time period
Accelerated	25 0C ± 2 0C/ 60 % RH ± 5 % RH or	6 months
	30 0C ± 2 0C/ 65 % RH ± 5 % RH or
	300C ± 2 0C/ 75 % RH ± 5 % RH
Long term	5 0C ± 3 0C	12 months or 6 months

Stability Study Storage condition for Freezer:

Study	Storage condition	Minimum period
Long term	-20 0C ± 5 0C	12 months or 6 months

Stability Study Execution:

Now it's time to select guidelines and prepare a detailed stability protocol for the stability study. The protocol should contain,

• Title, 
• Need/Scope of study, 
• Any abbreviations and definitions, 
• Responsibilities, 
• Packaging material details with vendor address, 
• API details with vendor address, 
• Sampling plan, 
• Timepoint with stability condition details, 
• Details about which type of testing should carry out, 
• Conclusion.

Execution of this protocol is carried out step by step. As per protocol Sampling is done. Sampled product is tested in the Quality Control lab and Microbiology lab on the initial stage. As given in protocol stability samples shall be kept in stability chambers according to given stability conditions and time period. On given period samples shall be withdrawn and tested. Product is analyzed stage-wise. During this stability study, the chamber's stability condition is monitored and recorded on daily basis. Any variation for more than 24 hours is reported and evaluated. After completion of all studies, the stability of the product is evaluated.

Stability study related more posts:

API Stability Study | Finished product | ICH Q1F Overview

Stability Study For New Drug Substances, Products | ICH Q1A (R2)

Stability Study Evaluation and Conclusion:

Evaluation of the Studied stability product is done on one summary report. This summary report should include the details of the product (Product name, Strength, Batch number, Batch size, Stability protocol number, Stability condition with time point), results of physical, chemical, biological, and microbiological tests, the Shelf life of the product, container closure system and storage condition. This summary report is the final conclusion of the stability study.