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Stability Studies Requirements in CTD: Research & Development Manager Al-Fares Pharmaceutical

The document discusses stability studies required for drug registration. It notes that stability studies provide evidence of how a drug's quality varies over time under different environmental factors like temperature, humidity, and light. The studies described include accelerated and long-term stability tests conducted on lab, pilot, and production batches using various packaging configurations and storage conditions. The results of these tests are reported in different sections of the CTD dossier to support establishing a drug's shelf life and storage conditions. Changes to a registered product that may require additional stability studies are also outlined.

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Oula Hatahet
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100 views25 pages

Stability Studies Requirements in CTD: Research & Development Manager Al-Fares Pharmaceutical

The document discusses stability studies required for drug registration. It notes that stability studies provide evidence of how a drug's quality varies over time under different environmental factors like temperature, humidity, and light. The studies described include accelerated and long-term stability tests conducted on lab, pilot, and production batches using various packaging configurations and storage conditions. The results of these tests are reported in different sections of the CTD dossier to support establishing a drug's shelf life and storage conditions. Changes to a registered product that may require additional stability studies are also outlined.

Uploaded by

Oula Hatahet
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
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Stability Studies

Requirements
in CTD
Ph. Oula Hatahet
Research & Development Manager
Al-Fares Pharmaceutical
Evidence on how the quality of a drug
substance or drug product varies with time
under the influence of a variety of
environmental factors such as temperature,
humidity and light.

ICH Q1A(R2): Stability testing of new drug substances and products -2003
Shelf Life
Drug product clinical Studies
Excipient
Excipients Compatibility

Formulation Drug Product


Development Packaging
Selection

API

API Stability Final


Process Impurity Packaging Interaction
Storage Condition Packaged
Product
API Bulk In-Process
Formal Stability In-Use Stability
Stability Stability Stability
Studies Studies
Studies Studies Studies

Product Manufacturing
Intermediate Finished
API Marketing
Product dosage Form

20/ 5
Test Sample: Laboratory batches
Study Type: Accelerated Study
Objective: Evaluation of the factors on the drug
substance
Module 3 Module 1

P. 2.6 Compatibility.3.2
Labeling 1.2
P. 3.2 Batch Formula.3.2
(Storage Conditions )
P.3.7 Container Closer system.3.2
Test Sample: Pilot/ Production Batches
Study Type: Accelerated / Long term Studies
Objective: Evaluation of the final formulation /
container for the various climate zones.

Module 3

3.2.P.3.8 Stability
3.2.P.8.1 Stability Summary Data
3.2.P.8.2 Protocol
3.2.P.8.3 Stability Data
• Design And Justification for Reduced stability Design
• Stress Study
• Analytical Procedure unique to stability Study
• Statistical Analysis.
• Shelf life
Test Sample: Production batches
Study Type: Long term Study
Objective: Confirmation of stability profile
on the production batch
Oral Powder For Reconstitution
Multi dose form (Eye Drops)
Reconstituted Vails
Samples should be exposed to light providing
an overall illumination of not less than 1.2
million lux hours and an integrated near
ultraviolet energy of not less than 200 watt
hours/square meter.
Stabi
lity S
tu dies i
n CT
D
Module 1 Not Part
of CTD
Regional
Administrative
Information

Nonclinical Clinical
Quality Overview Overview
Overall
Module Summary Nonclinical Clinical
2 Summaries Summary
CTD

Module 3 Module 4 Module 5

Quality Nonclinical Clinical


Study Reports Study Reports
Module 1 Module 2

Production site QOS


Primary Packaging Materials 2.3.S.7 Stability
Storage conditions (Labeling) 2.3.P.8 Stability
Shelf life in CPP

Stability Studies
in CTD
3.2.P.7 Stability 3.2.P.8 Stability
3.2.P.7.1 Stability Summary 3.2.P.8.1 Stability summary
3.2.P.7.2 Post approval Stability Protocol 3.2.P.8.2 Post approval Stability protocol
3.2.P.7.3 Stability Data 3.2.P.8.3 Stability Data

Module 3 - S Part Module 3 - P Part


Module 3 - S Part

3.2.P.7 Stability
3.2.P.7.1 Stability Summary
3.2.P.7.2 Post approval Stability Protocol
3.2.P.7.3 Stability Data

DMF
GMP
2 CoA Form Supplier & Manufacturer
Specification Form Supplier & Manufacturer

Ph. Oula Hatahet


Module 3 - P Part
3.2.P.8 Stability
3.2.P.8.1 Stability Summary

The Study conducted.

Design And Justification for Reduced stability Design

The result of the stability Study

Shelf life

Storage Conditions
3.2.P.8 Stability
Full
3.2.P.8.1 Stability Summary
Reduced
3.2.P.8.2 Post approval Stability protocol
Manufacturing Date
Manufacturing Site
Primary Packaging
Materials Used
Batch Size
Starting Date

In-Use
Photo-Stability
Invert- upright Position
3.2.P.8 Stability
3.2.P.8.1 Stability Summary
3.2.P.8.2 Post approval Stability protocol
3.2.P.8.3 Stability Data
•Analytical Procedure unique to stability Study.

• Stability Indicating Method

•Validation Chromatogram

•Chromatogram of One Batch Covering Time Period

•Statistical Analysis.

•Evaluation of Results
API
P.7 Stability.3.2
Stability Protocol
Sampling
Packaging Condition Tests Batches
Times

ºC 2 ± 40
PE Bags in
Cardboard 0,1,3,6 .Lot No
drums month
% 5 ± 75 Description
Assay
pH
ºC 2 ± 25 Impurities
PE Bags in 0,1,3,6
Cardboard month .Lot No
drums
% 5 ± 65
Stability Specification
FDF Stability Protocol
Summary of results
 Registration
 Change Production site
 Reregistration
Changes such as:
API Composition
Manufacturing of the product
Process New Strength Primary
Outside Packaging
approved range Changes
Changes

Shape or /Coloring
Excipient Size of Flavoring
Minor Container Changes
Changes Scale Up

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