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A main GMP requirement for GMP regulated active pharmaceutical ingredients (APIs) and drug products (DPs) is the need of a written stability program / plan.
The results of the stability testing are to be used in determining appropriate storage conditions and a product's expiration date. The WHO as well as the ICH have issued various guidelines for stability testing of marketed pharmaceutical products, products under development and stability testing of new Drug Substances (APIs).
The purpose of a stability testing program is to establish a re-test and to define storage conditions that could influence the quality of a drug substance or drug product depending on a variety of environmental factors such as temperature, humidity, and light.
This Standard Operating Procedure (SOP) / Stability Study Program (Plan) will certainly help you to set up a concurrent Study Plan and Protocol in compliance with regulatory expectations. This procedure is applicable to drug substances and drug products.
This Standard Operating Procedure / Stability Study Program (Plan) consist out of 29 pages including 5 attachments and need only a little amount of company-specific modification before it can be used.
Table of Content:
1. Regulatory Basis, Reference Documents
4. Responsibilities and Accountabilities
4.1 Quality Control (QC)
4.2 Quality Assurance
5.2 Testing frequency
5.3 Testing Time Intervals
5.4 Preserving the samples
5.5 Storage conditions
5.6 Extension & Excursion of Temperature and Humidity
5.7 Maintenance of stability chambers
5.8 Alarm setup and actions
5.9 Stability Failures
5.9.1 Specification failure
5.9.2 Out of trend failure
5.10 Locating the samples in Stability chambers
5.11 Content of Stability Protocol and Report
5.11.1 Illustrative data of API stability batches
5.11.2 Illustrative data of capsule/tablet stability batches
5.12 Stability testing results
5.12.2 Selection of Batches
5.12.3 Potential instability issues of Finished Pharmaceutical Product
5.12.4 Stability-indicating quality parameters
5.12.5 Significant Change of Finished Pharmaceutical Products
5.12.6 Forced degradation tests
5.12.7 Prequalification experience
5.12.8 Tests at elevated temperature and/or extremes of humidity
5.12.9 Requirements for predictive stress conditions
5.12.10 Stress testing of API in solution
5.12.11 Stress testing of Finished Pharmaceutical Products in solid state
5.13.2 Evaluation – Best Case
5.13.3 Visible variability and trend
5.13.4 Evaluation – Change with Time
5. 14 Release and shelf-life specifications
5.15 Stability Commitment
5.16 Additional or New Stability Data
Annexure-1: Format for Stability samples log book
Annexure-2: Format for Equipment Log for Humidity Chambers
Annexure-3: Format for Check list for Stability Chamber Breakdown
Annexure-4: Format for Verification of Safety Alarm System
Annexure-5: Format for reporting Long-term Stability Data
Annexure-6: Format for reporting Accelerated Stability Data
Stability Study Program / Plan
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