Guidelines for Evaluating the Impact of Storage Conditions on Drug Products
1) Purpose
The purpose of this SOP is to provide guidelines for assessing the impact of different storage conditions on the stability of drug products. The study aims to evaluate the effects of temperature, humidity, and light exposure on the safety, potency, and quality of drug products.
2) Scope
This SOP applies to all drug products manufactured, stored, or distributed by the organization, including oral, injectable, and topical formulations. It is intended for personnel involved in formulation development, quality control, and regulatory affairs.
3)
Formulation Development Team: Responsible for designing the stability study protocol.
Quality Control (QC) Team: Responsible for conducting stability tests and recording results.
QA Team: Responsible for reviewing data, approving the protocol, and ensuring compliance with regulatory standards.
4) Procedure
4.1 Study Design:
- Select stability-indicating parameters, such as appearance, assay, dissolution, and microbial limits, for evaluation.
- Define storage conditions to be tested, including accelerated (40°C/75% RH), intermediate (30°C/65% RH), and long-term (25°C/60% RH) conditions.
- Prepare a detailed study protocol outlining the sampling schedule, analytical methods, and acceptance criteria.
4.2 Sample Preparation:
- Prepare samples from representative production batches and label them with relevant details, including batch numbers, storage conditions, and sampling time points.
- Store samples in designated stability chambers under specified conditions.
4.3 Testing Schedule:
- Conduct initial testing to establish baseline data for the selected parameters.
- Perform follow-up testing at predetermined intervals (e.g., 1 month, 3 months, 6 months) to monitor changes over time.
- Document all test results and analyze data for trends or deviations from acceptance criteria.
4.4 Data Analysis and Reporting:
- Analyze data using statistical methods to determine the impact of storage conditions on product stability.
- Prepare a stability study report summarizing findings, conclusions, and recommendations for storage and handling conditions.
- Submit the report for QA review and archiving.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
RH: Relative Humidity
6) Documents, if any
Storage Condition Impact Study Protocol: Document detailing the study plan and methodology.
Analytical Data Records: Data sheets for all tests performed.
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
8) SOP Version
Version 1.0